2018年05月进口第一类医疗器械产品备案信息
发布日期:2018-6-8 点击数:1303新闻来源:国家药品监督管理局
 

201805月进口第一类医疗器械产品备案信息

序号

产品名称

备案号

备案人名称原文

生产地址原文

备案日期

状态

1

p63抗体试剂(免疫组织化学)

国械备20180714

Dako Denmark A/S

Produktionsvej 42, DK-2600 Glostrup, Denmark

2018-05-31

有效

2

外固定支架系统工具

国械备20151361

Smith & Nephew,Inc.

1450 Brooks Road, Memphis, Tennessee, 38116,USA; Via Mercadante 15 20124 Milano ITALY; Alemannenstraβe 14 ,D-78532 Tuttlingen 78352 Germany

2018-05-31

变更

3

外固定支架工具(包)

国械备20150798

Smith & Nephew,Inc.

1450 Brooks Road, Memphis, Tennessee,38116,USA;      

VIA MERCANDANTE 15 MILANO, Lombardia,ITALY 20124; ALEMANNENSTRASSE 14 TUTTLINGEN,Baden-Wurttemberg GERMANY, 78532;

2,Lengkok Telok Kumbar 1 Jalan Telok KumbarPenang, Pulau Pinang Malaysia;

11920 SCHACHENALLEE29 AARAU, Aargau SWITZERLAND CH-5001.

2018-05-31

变更

4

缓冲液

国械备20180713

HYPHEN BioMed

155 rue d’Eragny, 95000 Neuville-sur-Oise, France

2018-05-31

有效

5

全自动免疫检验系统用底物液

国械备20180712

Adaltis S.r.l.

Via Luigi Einaudi 7-Guidonia Montecelio 00012 Roma ITA

2018-05-31

有效

6

研光器

国械备20152057

ASA DENTAL S.p.A.

Via Valenzana, 60-55054 Bozzano (LU) -Italy

2018-05-31

变更

7

银汞合金输送器

国械备20152056

ASA DENTAL S.p.A.

Via Valenzana, 60-55054 Bozzano (LU) -Italy

2018-05-31

变更

8

骨撬

国械备20150325

 DePuy Ireland

Loughbeg Ringaskiddy Co.Cork Ireland

2018-05-30

变更

9

骨科钻头

国械备20150728

 DePuy (Ireland)

Loughbeg Ringaskiddy Co.Cork Ireland

2018-05-30

变更

10

膝关节固定器

国械备20150882

 DePuy (Ireland)

Loughbeg Ringaskiddy Co.Cork Ireland

2018-05-30

变更

11

骨锤

国械备20150875

Exactech,Inc.

2320 NW 66th,Court Gainesville,Florida 32653,USA

2018-05-30

变更

12

膝关节伸直间隙评估垫片

国械备20150731

 DePuy (Ireland)

Loughbeg Ringaskiddy Co.Cork Ireland

2018-05-30

变更

13

股骨髓腔探棒

国械备20150394

DePuy Ireland

 Loughbeg Ringaskiddy Co.Cork Ireland

2018-05-30

变更

14

螺钉取出器

国械备20150382

DePuy Ireland

Loughbeg Ringaskiddy Co.Cork Ireland

2018-05-30

变更

15

鼻咬切钳

国械备20160205

ArthroCare Corporation

28210 Constellation Rd Valencia, CA 91355

2018-05-30

变更

16

骨导引针

国械备20161269

GS Medical Co.,Ltd.

90, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea

2018-05-30

变更

17

胸腰椎融合器手术器械

国械备20160004

Spineart SA

20 route de Pré-Bois CP 1813 1215 Geneva (Switzerland)

2018-05-30

变更

18

样本稀释液

国械备20180707

Adaltis S.r.l.

Via Luigi Einaudi 7-Guidonia Montecelio 00012 Roma ITA

2018-05-30

有效

19

口腔开口器

国械备20180706

()오성엠앤디

경기도 김포시 양촌읍 황금로 109번길 57

2018-05-30

有效

20

组织钳

国械备20161919

MEDICON eG

Gänsäcker 15, 78532 Tuttlingen, GERMANY

2018-05-30

变更

21

转移帽

国械备20161082

BioHorizons Implant Systems, Inc.

2300 Riverchase Center, Birmingham, Alabama 35244 USA

2018-05-29

变更

22

正畸钳

国械备20180705

Dentsply GAC International

Calle Industrial Del Acero # 18 Parque Industrial “EI Vigia” Mexicali, Baja California 21397 Mexico

2018-05-29

有效

23

牙科种植修复用工具包

国械备20180704

Valoc AG

CH-4434 Hölstein

2018-05-29

有效

24

检查手套

国械备20180703

Central Medicare Sdn Bhd

PT 2609-2620Bt 8Jln Changkat Jong Mukim Changkat Jong 36000 Teluk IntanPerak MALAYSIA

2018-05-29

有效

25

样本稀释液

国械备20151076

DiaMed GmbH

Pra Rond 23, 1785 Cressier FR, Switzerland

2018-05-29

变更

26

孵育器

国械备20160759

DiaMed GmbH

18 avenue du Polygone-42300 ROANNE-France

2018-05-29

变更

27

孵育器

国械备20171203

DiaMed GmbH

Pra Rond 23, 1785 Cressier FR, SWITZERLAND

2018-05-29

变更

28

细胞保存液

国械备20170617

DiaMed GmbH

Pra Rond 23, 1785 Cressier FR, Switzerland

2018-05-29

变更

29

医用离心机

国械备20160760

DiaMed GmbH

18 avenue du Polygone-42300 ROANNE-France

2018-05-29

变更

30

苏木素染色液

国械备20170298

Leica Biosystems Richmond, Inc.

5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA

2018-05-29

变更

31

医用离心机

国械备20180068

DiaMed GmbH

Pra Rond 23, 1785 Cressier FR, SWITZERLAND

2018-05-29

变更

32

苏木素染色液

国械备20170296

Leica Biosystems Richmond, Inc.

5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA

2018-05-29

变更

33

苏木素染色液

国械备20160336

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-29

变更

34

苏木素染色液

国械备20160334

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-29

变更

35

苏木素染色液

国械备20160337

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-29

变更

36

橡皮障

国械备20170006

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-29

变更

37

血细胞分析用溶血剂

国械备20161433

HORIBA ABX SAS

Parc Euromédecine,rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

38

牙科种植体手术工具

国械备20180702

WARANTEC CO., Ltd.

#412, Suntec City, 474, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

2018-05-29

有效

39

血细胞分析用染色液

国械备20161697

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

40

血细胞分析用稀释液

国械备20161436

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

41

清洗液

国械备20151463

HORIBA ABX SAS

Parc Euromédecinerue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

42

血细胞分析用溶血剂

国械备20161437

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

43

血细胞分析用溶血剂

国械备20151132

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

44

血细胞分析用溶血剂

国械备20161411

HORIBA ABX SAS

Parc Euromédecine,rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

45

血细胞分析用稀释液

国械备20161434

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

46

血细胞分析用染色液

国械备20151462

HORIBA ABX SAS

Parc Euromédecine,rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

47

血细胞分析用溶血剂

国械备20161412

HORIBA ABX SAS

Parc Euromédecine,rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

48

血细胞分析用溶血剂

国械备20161438

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-29

变更

49

组织扩张器或乳房假体试模

国械备20170169

Allergan

Global Park Free Zone, La Aurora de Heredia 900 Parkway CRI

2018-05-28

变更

50

牙探针

国械备20160678

Ormco Corporation also trading as Sybron Endo

 6575 Butler Creek Road, Missoula, Montana, 59808, USA

2018-05-28

变更

51

牙科手术器械

国械备20180701

博美股份有限公司

桃園市桃園區汴洲里春日路149224

2018-05-28

有效

52

牙科树脂充填器

国械备20160367

KerrHawe S. A.

Via Strecce 4 P.O. 272, 6934 Bioggio Switzerland

2018-05-28

变更

53

牙科树脂充填器

国械备20170699

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

54

显微剪

国械备20180700

株式会社シャルマン

福井県鯖江市川去町6-8

2018-05-28

有效

55

核酸分析用磁珠试剂

国械备20160248

Roche Diagnostics GmbH

1080 US Highway 202 South, Branchburg, NJ 08876, USA

2018-05-28

变更

56

样本稀释液

国械备20151712

Roche Diagnostics GmbH

1080 US Highway 202 South, Branchburg, NJ 08876, USA

2018-05-28

变更

57

研光器

国械备20161043

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

58

核酸分析用病毒裂解试剂

国械备20160251

Roche Diagnostics GmbH

1080 US Highway 202 South, Branchburg, NJ 08876, USA

2018-05-28

变更

59

研光器

国械备20170104

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

60

拔髓针

国械备20160788

Ormco Corporation also trading as Sybron Endo

Bayerwaldstraβe 15, 81737 München, GERMANY

2018-05-28

变更

61

根管充填器

国械备20160553

Ormco Corporation also trading as Sybron Endo

1332 South Lone Hill Avenue Glendora, California 91740 USA;Calle 21 No 1103 AMP CD Industrial Uman Yucatan 97390 Mexico

2018-05-28

变更

62

根管充填器

国械备20160554

Ormco Corporation also trading as Sybron Endo

1332 South Lone Hill Avenue Glendora, California 91740 USA

2018-05-28

变更

63

根管锉

国械备20160608

Ormco Corporation also trading as Sybron Endo

1332 South Lone Hill Avenue Glendora, California 91740 USA; Calle 21 No 1103 AMP CD Industrial Uman Yucatan 97390 Mexico

2018-05-28

变更

64

成形片

国械备20170117

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

65

口腔X光摄片架

国械备20170032

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

66

研光器

国械备20170118

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

67

抛光杯

国械备20170115

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

68

橡皮障夹

国械备20150074

KerrHawe S.A.

Via Strecce 4, 6934 Bioggio, Switzerland

2018-05-28

变更

69

楔子

国械备20170236

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

70

研光器

国械备20170116

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

71

口角拉钩

国械备20170194

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

72

研光器

国械备20161935

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

73

核酸提取或纯化试剂

国械备20180699

Vela Operations Singapore Pte. Ltd.

NEUMANN-NEANDER-STR. 6-8, 52355 DUREN DEUTSCHLAND

2018-05-28

有效

74

手术工具

国械备20161592

BM KOREA CO.,LTD.

(Dangjeong-dong), 58, Dangjeong-ro, Gunpo-si, Gyeonggi-do, 435-832, Korea

2018-05-28

变更

75

组织钳

国械备20180698

SAHIL SURGICAL (PVT) LIMITED

Noul More, Roras Road, Sialkot-51310 Pakistan

2018-05-28

有效

76

研光器

国械备20170103

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

77

手术刀柄

国械备20180697

SAHIL SURGICAL (PVT) LIMITED

Noul More, Roras Road, Sialkot-51310 Pakistan

2018-05-28

有效

78

橡皮障楔线

国械备20170480

KerrHawe S.A.

Via Strecce 4 P.O. 272 6934 Bioggio Switzerland

2018-05-28

变更

79

海绵钳

国械备20180696

SAHIL SURGICAL (PVT) LIMITED

Noul More, Roras Road, Sialkot-51310 Pakistan

2018-05-28

有效

80

代型材料

国械备20180695

VERICOM CO., LTD

48Toegyegongdan 1-gilChuncheon-si, Gangwon-do, 200-944,Republic of KOREA

2018-05-28

有效

81

琼脂复制材料

国械备20151411

megadental GmbH

Seeweg 20,63654 Büdingen Germany

2018-05-25

变更

82

磷酸盐铸造包埋材料

国械备20151413

megadental GmbH

Seeweg 20,63654 Büdingen Germany

2018-05-25

变更

83

牙科种植手术辅助器械包

国械备20161777

Hager & Meisinger GmbH

Hansemannstraβe 10, 41468 Neuss Deutschland

2018-05-25

变更

84

螺丝起

国械备20170497

Hager & Meisinger GmbH

Hansemannstraβe 10, 41468 Neuss, Deutschland

2018-05-25

变更

85

检查手套

国械备20180694

W.A.RUBBERMATE CO.,LTD.

67/1 Bypass Road, Moo 4 Nongmaidaeng , Muang, Chonburi 20000, Thailand.

2018-05-25

有效

86

样本稀释液

国械备20151856

 Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-24

变更

87

样本稀释液

国械备20160094

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-24

变更

88

透气胶贴

国械备20150551

3M Company, 3M Health Care

3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA

2018-05-24

变更

89

透气胶带

国械备20150484

3M Company, 3M Health Care

3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA

2018-05-24

变更

90

医用冷敷贴

国械备20151768

3M Company, 3M Health Care

601 22nd Ave. South Brookings, South Dakota, 57006, USA

2018-05-24

变更

91

弹性胶带

国械备20161077

3M Company, 3M Health Care

610 North County Rd.19, Aberdeen, South Dakota, 57401, USA

2018-05-24

变更

92

硅胶压敏胶带

国械备20160504

3M Company, 3M Health Care

610 North County Rd.19, Aberdeen, South Dakota, 57401, USA

2018-05-24

变更

93

聚酯衬垫

国械备20151836

3M Deutschland GmbH

Marialoopsteenweg 51 8760 Meulebeke(Tielt) Belgium

2018-05-24

变更

94

样本稀释液

国械备20180693

INOVA Diagnostics, Inc.

9900 Old Grove Road San Diego California 92131 USA

2018-05-24

有效

95

固定用弹力束带

国械备20140110

3M Company, 3M Health Care

425 North Gateway Avenue. Rockwood, TN 37854 USA

2018-05-24

变更

96

正畸钳

国械备20160365

3M Unitek Corporation

见附件。

2018-05-24

变更

97

正畸钳

国械备20150219

3M Unitek Corporation

3232 N. Rockwell Street, Chicago, IL, 60618, United States

2018-05-24

变更

98

牙科镊

 国械备20150608

3M Unitek Corporation

Steinendorfer Straβe 27 - 42699 Solingen, Germany

2018-05-24

变更

99

托槽定位器

国械备20160247

3M Unitek Corporation

1828 Evergreen Street Duarte,CA 91010

2018-05-24

变更

100

探针

国械备20160245

3M Unitek Corporation

La Marnasse 63880 Olliergues France

2018-05-24

变更

101

 带环挺

国械备20150476

 3M Unitek Corporation

3232 N. Rockwell Street, Chicago, IL, 60618, United States

2018-05-24

变更

102

带环挺

国械备20150538

3M Unitek Corporation

2724 South Peck Road, Monrovia, California, 91016, USA.

2018-05-24

变更

103

牙科表面粘接剂去除器及托槽定位器

国械备20160440

3M Unitek Corporation

3232 N.Rockwell Street,Chicago,IL,60618,United States

2018-05-24

变更

104

扭力扳手

国械备20170499

Hager & Meisinger GmbH

Hansemannstraβe 10, 41468 Neuss, Deutschland

2018-05-24

变更

105

打磨抛光组件

国械备20170149

Hager & Meisinger GmbH

Hansemannstraβe 10, 41468 Neuss Deutschland

2018-05-24

变更

106

弓丝置入器

国械备20160246

3M Unitek Corporation

La Marnasse 63880 Olliergues France

2018-05-24

变更

107

牙科结扎丝压入器

国械备20160441

3M Unitek Corporation

28 Imaizumi Higashimatsuyama-shi Saitama 355-0042 Japan

2018-05-24

变更

108

牙探针

国械备20170422

3M Unitek Corporation

3232 N Rockwell Street, Chicago, IL 60618, United States

2018-05-24

变更

109

医用图像打印机

国械备20180692

Bermedi Medical Solutions GmbH

Bölschestraße 27, 12587 Berlin, Germany

2018-05-24

有效

110

医用X射线胶片

国械备20180691

Bermedi Medical Solutions GmbH

Bölschestraße 27, 12587 Berlin, Germany

2018-05-24

有效

111

玻璃纤维绷带

国械备20160217

3M Company, 3M Health Care

5500 Ooaza-Osanagi,Higashine-shi,Yamagata 999-3737 Japan

2018-05-24

变更

112

石膏衬垫

国械备20140238

3M Company, 3M Health Care

Marialoopsteenweg 51 8760 Meulebeke (Tielt), Belgium

2018-05-24

变更

113

弹性绷带

国械备20180690

Mölnlycke Health Care AB

Tubiton House Medlock Street Oldham OL1 3HS United Kingdom

2018-05-24

有效

114

根管锉

国械备20151818

Ormco Corporation also trading as Sybron Endo

1332 South Lone Hill Avenue Glendora, California 91740 USA;Calle 21 No 1103 AMP CD Industrial Uman Yucatan 97390 Mexico

2018-05-24

变更

115

螺丝起

国械备20140371

Alpha-Bio Tec. Ltd.

7 Hatnufa St., Kiryat Arye, POB 3936, Petach-TiKva, 4951025, Israel

2018-05-23

变更

116

上颌窦提升器

国械备20140365

Alpha-Bio Tec Ltd.

7 Hatnufa St., Kiryat Arye, POB 3936, Petach Tikva, 4951025 Israel

2018-05-23

变更

117

牙科种植定位器

国械备20140366

Alpha-Bio Tec. Ltd.

7 Hatnufa St., Kiryat Arye, POB 3936, Petach-TiKva, 4951025, Israel

2018-05-23

变更

118

样本释放剂

国械备20150850

Abbott Ireland Diagnostics Division

Lisnamuck, Longford, Co. Longford, Ireland

2018-05-23

变更

119

伊红染色液

国械备20170321

Leica Biosystems Richmond, Inc.

5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA

2018-05-23

变更

120

伊红染色液

国械备20161802

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-23

变更

121

伊红染色液

国械备20170299

Leica Biosystems Richmond, Inc.

5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA

2018-05-23

变更

122

苏木素染色液

国械备20160338

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-23

变更

123

伊红染色液

国械备20160471

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-23

变更

124

牙科电动抽吸系统

国械备20151899

DÜRR DENTAL SE

Höpfigheimer Str. 17, 74321 Bietigheim-Bissingen, Germany

2018-05-23

变更

125

牙科空气压缩机

国械备20140085

DÜRR DENTAL SE

Hoepfigheimer Strasse 17,74321 Bietigheim-Bissingen, Germany

2018-05-23

变更

126

牙科电动空压机

国械备20161426

DÜRR DENTAL SE

Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany

2018-05-23

变更

127

置骨器

国械备20161902

A.B. Dental Devices Ltd

19 Hayahalomim Street Ashdod 7761117 Israel

2018-05-23

变更

128

根管锉

国械备20161101

MICRO-MEGA SA

5-12, rue du Tunnel, 25006 BESANCON CEDEX FRANCE

2018-05-23

变更

129

螺丝起

国械备20150871

오스템임플란트()

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea

2018-05-23

变更

130

牙科种植定位器

国械备20161362

A.B. Dental Devices Ltd.

19 Hayahalomim Street Ashdod 7761117 Israel

2018-05-23

变更

131

螺丝起

国械备20170255

Alpha-Bio Tec. Ltd.

7 Hatnufa St., Kiryat Arye, POB 3936, Petach-TiKva, 4951025, Israel

2018-05-23

变更

132

自动染片机

国械备20180689

Lumatas Biosystems Inc

47747 Warm Springs Blvd Fremont,CA USA94539

2018-05-23

有效

133

探针

国械备20170512

Wexler Surgical, Inc.

11333 Chimney Rock Road, Suite 110 Houston, Texas 77035 USA

2018-05-23

变更

134

核酸染色液

国械备20180688

㈜나노엔텍

851-14 Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 18531, Republic of Korea

2018-05-22

有效

135

颅骨固定与修复手术器械

国械备20180687

Synthes GmbH

见附件。

2018-05-22

有效

136

腰椎固定带

国械备20180686

高禎實業有限公司

臺中市龍井區龍津里三港路32668

2018-05-22

有效

137

颈椎固定器

国械备20180685

高禎實業有限公司

臺中市龍井區龍津里三港路32668

2018-05-22

有效

138

医用外固定支具

国械备20180684

高禎實業有限公司

臺中市龍井區龍津里三港路32668

2018-05-22

有效

139

显微剪

国械备20180683

nopa instruments Medizintechnik GmbH

Weilatten 7 - 9 78532 Tuttlingen

2018-05-22

有效

140

样本稀释液

国械备20152165

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-22

变更

141

四肢内固定手术器械(包)

国械备20150980

Smith &Nephew, Inc.

1450 Brooks Road, Memphis,Tennessee,38116,USA

2018-05-22

变更

142

髓内钉工具系统

国械备20161580

Smith &Nephew, Inc.

见附件

2018-05-22

变更

143

踝关节融合接骨板工具系统

国械备20151797

Smith&Nephew, Inc.

1450 Brooks Road, Memphis, Tennessee, 38116,USA

2018-05-22

变更

144

骨科手术器械

国械备20160085

Smith &Nephew, Inc.

1450 Brooks Road Memphis, Tennessee 38116 USA;Alemannenstraβe 14,78532 TuttlingenGermany;2,Lengkok Teluk Kumbar 1 Jalan Teluk Kumbar 11920 Bayan Lepas, Penang, Malaysia

2018-05-22

变更

145

钢板螺钉工具系统

国械备20161364

Smith &Nephew, Inc.

1Alemannenstraße 14 D-78532 Tuttlingen 78532 Germany;21450 Brooks Road Memphis, Tennessee 38116 USA

2018-05-22

变更

146

根管锉

国械备20160552

Ormco Corporation also trading as Sybron Endo

1332 South Lone Hill Avenue Glendora, California 91740 USA; Calle 21 No 1103 AMP CD Industrial Uman Yucatan 97390 Mexico

2018-05-22

变更

147

自动染片机

国械备20180681

RAL DIAGNOSTICS

16 rue de la Comtesse, 25640 Marchaux, France

2018-05-22

有效

148

研光器

国械备20180680

AR INSTRUMED

Airport Road Gohad Pur,Sialkot 51360-PAKISTAN

2018-05-22

有效

149

全自动核酸提取纯化仪

国械备20140235

Abbott Molecular Inc.

1300 East Touhy Avenue, Des Plaines, IL 60018, USA

2018-05-22

变更

150

眼科镊

国械备20180065

BAUSCH & LOMB, INC.

499 SOVEREIGN CT. MANCHESTER, MO USA 63011

2018-05-22

变更

151

眼科手术刀

国械备20180066

BAUSCH & LOMB, INC.

499 SOVEREIGN CT. MANCHESTER, MO USA 63011

2018-05-22

变更

152

眼用剪

国械备20180046

BAUSCH & LOMB, INC.

499 SOVEREIGN CT. MANCHESTER, MO USA 63011

2018-05-22

变更

153

眼用测量器

国械备20171165

BAUSCH & LOMB, INC.

499 SOVEREIGN CT. MANCHESTER, MO USA 63011

2018-05-22

变更

154

医用头灯

国械备20180679

GENERAL SCIENTIFIC CORP.

77 Enterprise Dr., Ann Arbor, MI 48103

2018-05-22

有效

155

造口袋

国械备20180677

KONFORT OZEL SAGLIK HIZMETLERI TIBBI MALZ. SAN VE TIC LTD STI

ORGANIZE SANAYI BOLGESI 9.CADDE NO:32 ESKISEHIR/ TURKEY

2018-05-21

有效

156

牙科用研磨材料

国械备20180676

Ivoclar Vivadent AG

Rastatter Straβe 30, 75179 Pforzheim, Germany

2018-05-21

有效

157

弹性绷带

国械备20180675

Kowa Company Ltd.

5-321 Osaki, Kahoku-shi, Ishikawa 929-1127 Japan

2018-05-21

有效

158

弹性绷带

国械备20180674

Kowa Company Ltd.

1619, Yamaguchi, Kouhoku-machi, Kishima-gun, Saga-Ken 849-0501 Japan

2018-05-21

有效

159

自动组织脱水机

国械备20150787

Leica Biosystems Nussloch GmbH 

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-21

变更

160

牙科用研磨材料

国械备20180673

株式会社 松风プロダクツ京都

京都府久世郡久御山町市田新珠城21番地1

2018-05-18

有效

161

硅橡胶复制材料

国械备20180672

Vericom Co., Ltd

48Toegyegongdan 1-gil Chuncheon-si, Gangwon-do, 200-944,Republic of Korea

2018-05-18

有效

162

牙用分离器(包)

国械备20180671

AR INSTRUMED

Airport Road Gohad Pur,Sialkot 51360-PAKISTAN

2018-05-18

有效

163

髋臼杯系统工具

 国械备20140147

Depuy Orthopaedics, Inc.

700 Orthopaedic Drive Warsaw Indiana 46582 USA

2018-05-18

变更

164

医用手臂吊带

国械备20180670

璟茂實業股份有限公司

新北市瑞芳區(魚桀)魚坑路67-3

2018-05-18

有效

165

样本稀释液

国械备20150124

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

166

样本稀释液

国械备20160165

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

167

分配头

国械备20180669

3M Deutschland GmbH

351, Asahi-machi, Kasama-shi, Ibaraki-ken 309-1717, Japan

2018-05-18

有效

168

弹力绷带

 国械备20150894

3M Company, 3M Health Care

3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA

2018-05-18

变更

169

样本稀释液

国械备20152166

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

170

样本稀释液

国械备20152164

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

171

样本稀释液

国械备20160333

Siemens Healthcare Diagnostics Inc.

600-1, Minami-issiki, Nagaizumi-Cho, Sunto-gun, Shizuoka-ken, 411-0932, Japan

2018-05-18

变更

172

样本稀释液

国械备20160345

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

173

样本稀释液

国械备20150068

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

174

弹力绷带

国械备20161076

3M Company, 3M Health Care

601 22nd Ave. South Brookings, South Dakota, 57006, USA

2018-05-18

变更

175

样本稀释液

国械备20151866

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-18

变更

176

膝关节固定器

国械备20170505

Disk dr. Co., Ltd.

(Seongsu-dong 2(i)-ga, Motor City Bldy.),  #601, 49, Gwangnaru-ro 6-gil, Seongdong-gu, Seoul

2018-05-18

变更

177

口腔科注射头和混合头

国械备20170501

Kerr Corporation also trading as Pentron Clinical

Ruetistrasse 7 Haag, Sankt Gallen Switzerland 9469

2018-05-18

变更

178

口腔科双组份材料混配枪

国械备20170796

Kerr Corporation

Ruetistrasse 7 Haag, Sankt Gallen Switzerland 9469

2018-05-18

变更

179

口腔科双组份材料混配枪

国械备20170502

Kerr Corporation also trading as Pentron Clinical

Ruetistrasse 7 Haag, Sankt Gallen Switzerland 9469

2018-05-18

变更

180

免疫组化抗原修复缓冲液

国械备20150540

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-17

变更

181

免疫显色试剂

国械备20150558

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-17

变更

182

脱腊液

国械备20140293

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-17

变更

183

原位杂交用蛋白酶

国械备20150495

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-17

变更

184

免疫显色试剂

国械备20151000

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-17

变更

185

苏木素染色液

国械备20151600

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-17

变更

186

自动组织脱水机

国械备20150514

Leica Biosystems Nussloch GmbH

12 Teban Gardens Crescent Singapore 608924 SINGAPORE

2018-05-17

变更

187

丝攻

国械备20180668

Medartis AG

Hochbergerstr. 60E, 4057 Basel, Schweiz

2018-05-17

有效

188

骨科钻头

国械备20150381

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive, Warsaw, IN 46582, U.S.A

2018-05-17

变更

189

显微镊

国械备20150397

Aesculap AG

Am Aesculap-Platz, 78532 Tuttlingen, Germany

2018-05-17

变更

190

试模

国械备20150412

DePuy International, Ltd.

St Anthony’s RoadLeedsLS11 8DTUnited Kingdom

2018-05-17

变更

191

肩关节手术工具

国械备20160185

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive, Warsaw, Indiana 46582, USA

2018-05-17

变更

192

钢板弯曲器

国械备20180667

Medartis AG

Hochbergerstr. 60E, 4057 Basel, Schweiz

2018-05-17

有效

193

样本稀释液

国械备20152163

Siemens Healthcare Diagnostics Inc.

333 Coney Street, East Walpole, Massachusetts 02032, USA

2018-05-17

变更

194

冷冻切片机

国械备20161066

 Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

195

冷冻切片机

国械备20161064

Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

196

染色机

国械备20151320

Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

197

冷冻切片机

国械备20161067

Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

198

脊柱手术器械包

国械备20180666

DePuy Spine, Inc.

50 Scotland Blvd, Bridgewater Massachusetts, 02324 USA

2018-05-17

有效

199

染色机

国械备20151853

Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

200

染色机

国械备20151321

Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

201

骨钻

国械备20180665

A. TITAN INSTRUMENTS, INC.

10 Centre Drive, Orchard Park, NY 14127

2018-05-17

有效

202

冷冻切片机

国械备20150367

Leica Biosystems Nussloch GmbH

Heidelberger Strasse 17-19 69226 Nussloch Germany

2018-05-17

变更

203

牙龈刀

国械备20180664

A. TITAN INSTRUMENTS, INC.

10 Centre Drive, Orchard Park, NY 14127

2018-05-17

有效

204

样本稀释液

国械备20170585

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

205

样本稀释液

国械备20162044

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

206

样本稀释液

国械备20170232

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

207

样本稀释液

国械备20160269

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

208

免疫显色试剂

国械备20160636

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-16

变更

209

免疫显色试剂

国械备20160635

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-16

变更

210

样本稀释液

国械备20160753

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

211

样本稀释液

国械备20160268

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

212

样本稀释液

国械备20170424

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

213

样本稀释液

国械备20170191

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-16

变更

214

根管充填器

国械备20180663

MAILLEFER INSTRUMENTS HOLDING S.A.R.L.

Chemin du Verger 3 CH-1338 Ballaigues Switzerland

2018-05-16

有效

215

代型材料

国械备20180662

DENTSPLY International, Inc. Prosthetics Division

570 West College Avenue York Pennsylvania 17401 USA

2018-05-16

有效

216

透气胶贴

国械备20150361

3M Company, 3M Health Care

3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA

2018-05-16

变更

217

样本稀释液

国械备20170698

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-15

变更

218

样本稀释液

国械备20152001

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-15

变更

219

缓冲液

国械备20170256

EUROIMMUN Medizinische Labordiagnostika AG

Seekamp 31, D-23560 Lübeck, Germany

2018-05-15

变更

220

样本稀释液

国械备20170272

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-15

变更

221

样本稀释液

国械备20161686

EUROIMMUN Medizinische Labordiagnostika AG

Seekamp 31, D-23560 Lübeck, Germany

2018-05-15

变更

222

样本稀释液

国械备20151941

EUROIMMUN Medizinische Labordiagnostika AG

Seekamp 31, D-23560 Lübeck, Germany

2018-05-15

变更

223

清洗液

国械备20151701

EUROIMMUN Medizinische Labordiagnostika AG

Seekamp 31, D-23560 Lübeck, Germany

2018-05-15

变更

224

检查手套

国械备20170208

Henry Schein Services GmbH

Lot 1365, Batu 17, Jalan Sungai Sembilang, Jeram, Kuala Selangor, Selangor Darul Ehsan 45800 Malaysia

2018-05-15

变更

225

免疫组化抗原修复缓冲液

国械备20150328

Leica Biosystems Newcastle Ltd

Second Avenue, Heatherhouse Industrial Estate, Irvine, KA12 8NB, United Kingdom

2018-05-15

变更

226

免疫显色试剂

国械备20150983

Leica Biosystems Newcastle Ltd

Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom

2018-05-15

变更

227

扭力扳手

国械备20140364

Alpha-Bio Tec Ltd.

7 Hatnufa St., Kiryat Arye, POB 3936, Petach Tikva, 4951025 Israel

2018-05-15

变更

228

种植体扫描体

国械备20180660

Elos Medtech Pinol A/S

Engvej 33, Gørløse 3330, Denmark

2018-05-15

有效

229

前交叉韧带修复系统手术工具

国械备20180659

Medos International SARL

详见附件。

2018-05-15

有效

230

反向杂交荧光染色液 PE-Conjugated Streptavidin

国械备20150012

One Lambda, Inc.

21001 Kittridge Street, Canoga Park, CA 91303 USA

2018-05-15

变更

231

成形片及成形片夹

国械备20180658

Ultradent Products, Inc.

505 West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA

2018-05-14

有效

232

螺丝起

国械备20180657

WARANTEC Co., Ltd.

#412, Suntec City, 474, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

2018-05-14

有效

233

缓冲液

国械备20151545

Leica Biosystems Newcastle Ltd

3506 South Broadway Saint Louis MO 63118

2018-05-14

变更

234

免疫显色试剂

国械备20150984

Leica Biosystems Newcastle Ltd

Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom

2018-05-14

变更

235

膝关节手术器械

国械备20140291

Smith & Nephew,Inc.

1450 Brooks Road Memphis Tennessee 38116 USA;

2 Lengkok Teluk Kumbar 1 Jalan Teluk Kumbar 11920 Bayan Lepas, Penang Malaysia

2018-05-11

变更

236

髓内钉手术工具包

国械备20180656

Sanatmetal Orthopaedic&Traumatologic Equipment Manufacturer Ltd

Eger Faiskola u.5. H-3300 Hungary

2018-05-11

有效

237

髋关节拉钩

国械备20151330

Smith & Nephew,Inc.

1450 Brooks Road, Memphis, Tennessee, 38116,USA

Alemannenstraβe 14, Tuttlingen, 78532, Germany.

2018-05-11

变更

238

样本稀释液

国械备20170425

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-10

变更

239

样本稀释液

国械备20160325

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-10

变更

240

样本稀释液

国械备20170697

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom

2018-05-10

变更

241

手持式眼睑张开器

国械备20180655

TearScience,Inc

5151 McCrimmon Parkway Suite 250 Morrisville North Carolina 27560 USA

2018-05-10

有效

242

样本稀释液

国械备20140369

DiaSorin Inc.

1951 Northwestern Avenue P.O. Box 285 Stillwater, Minnesota 55082 USA

2018-05-10

变更

243

口镜

国械备20180654

MAJESTIC INSTRUMENTS

Opposite Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan

2018-05-10

有效

244

牙科剪

国械备20180653

MAJESTIC INSTRUMENTS

Opposite Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan

2018-05-10

有效

245

成形片

国械备20180652

Polydentia SA

Via Cantonale 47,CH-6805 Mezzovico

2018-05-10

有效

246

医用冷敷贴

国械备20160015

得生製藥股份有限公司二廠

No.42-1,Huan Gong Road, Yong Kang District, Tainan City, Taiwan

2018-05-10

变更

247

苏木素-伊红染色液(H-E

国械备20170724

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-10

变更

248

刚果红染色液

国械备20161939

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-10

变更

249

苏木素-伊红染色液(H-E

国械备20170723

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-10

变更

250

苏木素-伊红染色液(H-E

国械备20161803

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-10

变更

251

阿利辛蓝染色液

国械备20161938

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-10

变更

252

眼科手术刀

国械备20180651

Amidia AG

Mattenstrasse 11, 2555 Brügg BE Switzerland

2018-05-10

有效

253

全髋关节置换手术手动工具

国械备20140087

Smith & Nephew,Inc.

1)1450 Brooks Road, Memphis, Tennessee, 38116, USA

2)Alemannenstraβe 14, D-Tuttlingen, 78532, Germany

3)2 LengkokTelukKumbar 1, JalanTelukKumbar, 11920 Bayan Lepas, Penang,Malaysia

2018-05-09

变更

254

冷冻包埋剂

国械备20140125

Leica Biosystems Richmond, Inc.

5205 Route 12,P.O.Box 528 Richmond, Illinois 60071,USA

2018-05-09

变更

255

过碘酸雪夫染色液

国械备20161940

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-09

变更

256

冷冻包埋剂

国械备20140126

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-09

变更

257

胶囊内牙科材料推送器

国械备20171034

3M ESPE Dental Products

770 River Road ,Shelton, Connecticut, 06484, USA

2018-05-09

变更

258

印模材料输送器

国械备20170810

3M Deutschland GmbH

Ohmstraße 3, 86899 Landsberg, Germany

2018-05-09

变更

259

骨测量器

国械备20160157

Smith & Nephew,Inc.

1450 Brooks Road, Memphis,Tennessee,38116,USA

2018-05-09

变更

260

髋关节手术器械

国械备20151787

Smith & Nephew,Inc.

见附件

2018-05-09

变更

261

膝关节手术器械

国械备20160155

Smith & Nephew, Inc.

请见附表3

2018-05-09

变更

262

伊红染色液

国械备20161801

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-09

变更

263

样本保存液

国械备20140224

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O. Box 528 Richmond Illinois 60071 USA

2018-05-09

变更

264

冷冻包埋剂

国械备20170649

Leica Biosystems Richmond, Inc.

Unit 80 Mochdre Industrial Estate, Newtown, Powys, SY16 4LE, UK

2018-05-09

变更

265

脱钙液

国械备20140118

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-09

变更

266

组织固定液

国械备20160444

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-09

变更

267

吸引管

国械备20160696

 Aesculap AG

 Am Aesculap-Platz, 78532 Tuttlingen, Germany

2018-05-09

变更

268

膝关节手术器械

国械备20151696

Smith & Nephew,Inc.

1450 Brooks Road Memphis Tennessee 38116 USA; 2 Lengkok Teluk Kumbar 1 Jalan Teluk Kumbar 11920 Bayan Lepas, Penang  Malaysia.

2018-05-09

变更

269

打入器

国械备20161382

Oticon Medical AB

Datavägen 37B,SE-436 32 Askim,Sweden

2018-05-08

变更

270

骨科用螺丝刀

国械备20160351

Oticon Medical AB

Datavägen 37B,SE-436 32 Askim,Sweden

2018-05-08

变更

271

试模

国械备20160692

Oticon Medical AB

Datavägen 37B,SE-436 32 Askim,Sweden

2018-05-08

变更

272

骨科用螺丝刀

国械备20160691

Oticon Medical AB

Datavägen 37B,SE-436 32 Askim,Sweden

2018-05-08

变更

273

扳手

国械备20161383

Oticon Medical AB

Datavägen 37B,SE-436 32 Askim,Sweden

2018-05-08

变更

274

糖化血红蛋白溶血剂

国械备20151494

Siemens Healthcare Diagnostics Inc.

8365 Valley PikeMiddletown, VA 22645 USA

2018-05-08

变更

275

缓冲液

 国械备20161151

Siemens Healthcare Diagnostics Inc.

3-1-2 Musashino, Akishima-City, Tokyo 196-8558, Japan

2018-05-08

变更

276

缓冲液

国械备20151660

Siemens Healthcare Diagnostics Inc.

3-1-2 Musashino, Akishima-City, Tokyo196-8558, Japan

2018-05-08

变更

277

 缓冲液

国械备20151661

Siemens Healthcare Diagnostics Inc.

3-1-2 Musashino, Akishima-City, Tokyo196-8558, Japan

2018-05-08

变更

278

离心涂片机

国械备20150720

サクラ精機株式会社

75.5, 1MOJIYA, CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-08

变更

279

自动染片机

国械备20170411

サクラ精機株式会社

75-5, IMOJIYA, CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-08

变更

280

包埋机

国械备20170146

サクラ精機株式会社

75-5, IMOJIYA, CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-08

变更

281

骨膜剥离器

国械备20180650

A. TITAN INSTRUMENTS, INC.

10 Centre Drive, Orchard Park, NY 14127

2018-05-08

有效

282

牙科剪

国械备20180649

A. TITAN INSTRUMENTS, INC.

10 Centre Drive, Orchard Park, NY 14127

2018-05-08

有效

283

牙科种植定位器

国械备20180648

 MIS Implants Technologies Ltd.

 Bar Lev Industrial Park,2015600,Israel

2018-05-08

有效

284

阿利辛蓝—过碘酸雪夫氏染色液

国械备20161937

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-08

变更

285

脱钙液

国械备20140119

Leica Biosystems Richmond, Inc.

5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA

2018-05-08

变更

286

外科牵开器

国械备20180343

TeDan Surgical Innovations, LLC

12615 W. Airport Blvd, Suite 200, Sugar Land, TX 77478 United States

2018-05-08

变更

287

妇产科手术器械

国械备20180647

Prestige Surgical Instruments (Pvt) Ltd.

Roras Road, Nowl, Sialkot-Pakistan

2018-05-07

有效

288

骨锉

国械备20160513

Aesculap AG

Am Aesculap-Platz, 78532 Tuttlingen, Germany

2018-05-07

变更

289

清洗液

国械备20151464

HORIBA ABX SAS

Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France

2018-05-07

变更

290

采血笔

国械备20160424

Roche Diabetes Care GmbH

Sandhofer Strasse 116, 68305 Mannheim, Germany

2018-05-07

变更

291

冷冻包埋剂

国械备20170682

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

292

巴氏染色液

国械备20171032

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

293

巴氏染色液

国械备20171030

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

294

脊柱手术工具包

国械备20180646

Stryker Spine, INC

ZI Marticot 33610 Cestas, France

2018-05-04

有效

295

巴氏染色液

国械备20171036

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

296

巴氏染色液

国械备20171037

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

297

分化液

国械备20171087

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

298

分化液

国械备20171088

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

299

口垫

国械备20180645

Hager & Werken GmbH & Co.KG

Ackerstraße 1. D-47269 Duisburg Germany

2018-05-04

有效

300

眼科镊

国械备20161521

Bausch & Lomb Incorporated

3365 Tree Court Industrial Blvd St. Louis, MO 63122 USA;

499 Sovereign Court Manchester MO 63011, USA

2018-05-04

变更

301

眼用剪

国械备20161680

Bausch & Lomb Incorporated

3365 Tree Court Industrial Blvd St. Louis MO 63122 USA; 499

Sovereign Court Manchester MO 63011 USA

2018-05-04

变更

302

注吸器

国械备20161780

Bausch & Lomb Incorporated

3365 Tree Court Industrial Blvd St. Louis, MO 63122 USA;

499 Sovereign Court Manchester MO 63011, USA

2018-05-04

变更

303

眼科手术刀

国械备20161907

Bausch & Lomb Incorporated

3365 Tree Court Industrial Blvd St. Louis, MO 63122 USA;

499 Sovereign Court Manchester MO 63011, USA

2018-05-04

变更

304

自动组织脱水机

国械备20170560

サクラ精機株式会社

75-5, IMOJIYA,CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-04

变更

305

组织脱水机

国械备20161922

サクラ精機株式会社

75-5, IMOJIYA, CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-04

变更

306

自动组织脱水机

国械备20170195

サクラ精機株式会社

75-5, IMOJIYA,CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-04

变更

307

自动组织脱水机

国械备20161905

サクラ精機株式会社

75-5, IMOJIYA, CHIKUMA-CITY, NAGANO.PREF., JAPAN

2018-05-04

变更

308

切片机

国械备20180641

大和光機工業株式会社

埼玉県朝霞市膝折町二丁目1443

2018-05-04

有效

309

MOC-31抗体试剂(免疫组织化学)

国械备20180642

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-04

有效

310

Kappa链抗体试剂(免疫组织化学)

国械备20180643

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-04

有效

311

IgG抗体试剂(免疫组织化学)

国械备20180644

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-04

有效

312

打磨抛光组件

国械备20170041

WORLD BIO TECH CO., LTD.

BizCenter-302,(Sangdaewon-dong, SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do

2018-05-04

变更

313

正畸钳

国械备20170044

WORLD BIO TECH CO., LTD.

BizCenter-302,(Sangdaewon-dong, SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do

2018-05-04

变更

314

牙科电动抽吸系统

国械备20180640

CATTANI SPA

Via Natta,, 6/A-43122 Parma (PR) Italia

2018-05-04

有效

315

眼科手术辅助用钩

国械备20161778

Bausch & Lomb Incorporated

3365 Tree Court Industrial Blvd St. Louis, MO 63122 USA;

499 Sovereign Court Manchester MO 63011, USA

2018-05-04

变更

316

牙用尺

国械备20180639

()오성엠앤디

경기도 김포시 양촌읍 황금로 109번길 57

2018-05-04

有效

317

返蓝染色液

国械备20170598

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

318

冷冻包埋剂

国械备20170730

Richard-Allan Scientific Co.

4481 Campus Drive, Kalamazoo, Michigan 49008 USA

2018-05-04

变更

319

CD23抗体试剂(免疫组织化学)

国械备20180638

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-04

有效

320

CD7抗体试剂(免疫组织化学)

国械备20180637

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-04

有效

321

钻针深度停止器

国械备20171119

Alpha-Bio Tec. Ltd.

7 Hatnufa St., Kiryat Arye, POB 3936, Petach-TiKva, 4951025, Irsael

2018-05-03

变更

322

染色机

国械备20171212

Leica Biosystems Nussloch GmbH

1750A Costner Drive Warrington ,PA 18976

2018-05-03

变更

323

HPV探针试剂(原位杂交法)

国械备20180636

Roche Diagnostics GmbH

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-03

有效

324

Lambda链抗体试剂(免疫组织化学)

国械备20180635

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-03

有效

325

Actin抗体试剂(免疫组织化学)

国械备20180634

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-03

有效

326

转运车

国械备20180633

Linet spol. s r.o.

Želevcice 5, 274 01 Slaný, CZECH REPUBLIC

2018-05-03

有效

327

HPV探针试剂(原位杂交法)

国械备20180632

Roche Diagnostics GmbH

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-03

有效

328

流式细胞分析用鞘液

国械备20151489

Bio-Rad Laboratories, Inc.

4000 Alfred Nobel Drive, Hercules, CA 94547USA

2018-05-03

变更

329

清洗液

国械备20151108

Bio-Rad Laboratories, Inc.

4000 Alfred Nobel Drive, Hercules, CA 94547USA

2018-05-03

变更

330

骨刮匙

国械备20180631

Greatbatch Medical

4545 Kroemer Road Fort Wayne, IN 46818 USA

2018-05-03

有效

331

研磨材料

国械备20161288

Micerium S.p.A.

Via G. Marconi 83, I-16036 Avegno (GE)-Italy

2018-05-03

变更

332

CD22抗体试剂(免疫组织化学)

国械备20180630

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

333

IgM 抗体试剂(免疫组织化学)

国械备20180629

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

334

Tyrosinase抗体试剂(免疫组织化学)

国械备20180628

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

335

EZH2抗体试剂(免疫组织化学)

国械备20180627

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

336

CD44抗体试剂(免疫组织化学)

国械备20180626

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

337

IgA抗体试剂(免疫组织化学)

国械备20180625

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

338

细胞角蛋白17抗体试剂(免疫组织化学)

国械备20180624

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

339

AMACR/p504s抗体试剂(免疫组织化学)

国械备20180623

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

340

PSA抗体试剂(免疫组织化学)

国械备20180622

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

341

CD68抗体试剂(免疫组织化学)

国械备20180621

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

342

Kappa链抗体试剂(免疫组织化学)

国械备20180620

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

343

细胞角蛋白10抗体试剂(免疫组织化学)

国械备20180619

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

344

口腔观察仪

国械备20170947

廣達電腦股份有限公司

桃園市龜山區文化里文化二路1884

2018-05-02

变更

345

Lambda链抗体试剂(免疫组织化学)

国械备20180618

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA

2018-05-02

有效

346

剥离器

国械备20180617

Peter Lazic GmbH

Immelmannweg 2 78532 Tuttlingen Germany

2018-05-02

有效

347

骨锉

国械备20180616

Rebstock Instruments GmbH

In Weiheräcker 7 D-78589 Dürbheim Germany

2018-05-02

有效

348

骨探针

国械备20180615

Rebstock Instruments GmbH

In Weiheräcker 7 D-78589 Dürbheim Germany

2018-05-02

有效

349

胸腔止血钳

国械备20180614

Rebstock Instruments GmbH

In Weiheräcker 7 D-78589 Dürbheim Germany

2018-05-02

有效

350

浮标式氧气吸入器

国械备20151180

GIA Form Szerszám-és Alkatrészgyártó Kft.

HRSZ 076/36 H - 2030 Érd,Hungary

2018-05-22

无效

上一条:提升主动服务意识——第一时间获取延续注册审批信息   下一条:关于进一步加强机构改革期间药品医疗器械化妆品监管工作的通知
关于我们|联系我们|会员登录|会员注册|忘记密码|航空信息|火车信息|气象信息|旅游信息
  版权所有:中国医疗器械行业协会医用高分子制品分会  WWW.CNCAMDA.ORG
电话:010-68330336  邮政编码:100036  地址:北京市海淀区复兴路17号国海广场D座1815
未经书面许可严禁转载和复制本站的任何信息  目前您是第4167838位     技术支持:温州百度