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牙科手术器械包等139项进口第一类医疗器械产品备案获批
发布日期:2023-05-11 22:11浏览次数:1775次
2023年5月11日，国家药监局发布《2023年4月进口第一类医疗器械产品备案信息》，2023年4月累计批准医用检查手套、牙科手术器械包、呼吸训练器等139项进口第一类医疗器械备案事项。详见正文。

2023年5月11日，国家药监局发布《2023年4月进口第一类医疗器械产品备案信息》，2023年4月累计批准医用检查手套、牙科手术器械包、呼吸训练器等139项进口第一类医疗器械备案事项。详见正文。

第一类医疗器械产品备案.jpg

2023年4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全自动免疫检验系统用终止液国械备20160411号Phadia   ABRapsgatan   7P, P.O. Box 6460, 751 37 Uppsala2023-04-28 变更
2样本稀释液国械备20160409号Phadia   ABRapsgatan   7P, P.O.Box 6460, 751 37 Uppsala2023-04-28 变更
3清洗液国械备20160410号Phadia   ABRapsgatan   7P, P. O. Box 6460, 751 37 Uppsala2023-04-28 变更
4扭力扳手国械备20230257号????   ????????   ??? ?????4? 23-32023-04-28 有效
5血细胞分析用溶血剂国械备20230256号シスメックス株式会社兵庫県小野市匠台17番地2023-04-28 有效
6血细胞分析用染色液国械备20230255号シスメックス株式会社兵庫県小野市匠台17番地2023-04-28 有效
7医用检查手套国械备20230254号Koon   Seng Sdn.Bhd.PTD   16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-04-27 有效
8医用检查手套国械备20230253号Koon   Seng Sdn.Bhd.PTD   16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-04-27 有效
9脊柱外科手术器械包国械备20161359号CM   Instrumente GmbH G?ns?cker   56，78532 Tuttlingen，Germany2023-04-27 变更
10绑扎胶布国械备20170250号3M   Thailand Limited53/1   Soi Sukhapiban 2, Tambol Rahaeng, Amphur, Lardloomkaew, Pathumthani 12140,   Thailand2023-04-27 无效
11血细胞分析用染色液国械备20230252号シスメックス株式会社兵庫県小野市匠台17番地2023-04-27 有效
12血细胞分析用稀释液国械备20230251号シスメックス株式会社兵庫県小野市匠台17番地2023-04-27 有效
13鼻骨锉国械备20161945号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstra?e 8, 78532 Tuttlingen,   GERMANY2023-04-27 变更
14CD79a检测试剂国械备20230250号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
15TNFα检测试剂国械备20230249号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
16CD79a检测试剂国械备20230248号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
17全自动核酸提取纯化仪国械备20150040号HAMILTON   BONADUZ AGVia   Crusch 8 CH-7402 Bonaduz Switzerland2023-04-26 变更
18AMACR/p504s抗体试剂（免疫组织化学）国械备20181784号Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2023-04-25 变更
19鼻组织钳国械备20161696号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France; Schlo??ckerweg 6/1, 78582 Balgheim, Germany2023-04-25 变更
20显微持针钳国械备20161942号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-04-25 变更
21 革兰染色液 Color Gram 2 (COLOR GRAM 2-F) 国械备20140221号bioMérieux   SASite   de Montesquieu – Bordeaux Technopolis 33650 MARTILLAC France2023-04-25 变更
22替代体国械备20161880号  DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal，SWEDEN 2023-04-25 变更
23楔子国械备20181129号Polydentia   SAVia   Cantonale 47,CH-6805 Mezzovico2023-04-25 变更
24打磨抛光组件国械备20170149号Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss Deutschland 2023-04-25 变更
25上/下肢医用外固定支具国械备20230247号JC   OrthoHeal Private LimitedJC   OrthoHeal Private Limited GF-33/34, Classic Towers,Near Akota Garden,   Akota,Vadodara, Gujarat-390020，India2023-04-25 有效
26放射治疗患者用固定装置国械备20230246号Medtec,   LLC dba CIVCO Radiotherapy1401   8th St. SE, Orange City, IA, 51041, United States2023-04-25 有效
27生物显微镜国械备20210551号株式会社エビデント長野県上伊那郡辰野町大字伊那富6666番地2023-04-24 变更
28牙科手术器械包国械备20230245号ABRAHAM   BLACKSMITHAbrona   Street, Small Industrial Estate, Sialkot-51310-Pakistan2023-04-23 有效
29影像板及暗盒国械备20200585号PaloDEx   Group OyNahkelantie   160, FI-04300 Tuusula, Finland2023-04-23 变更
30口腔数字观察仪国械备20200629号WINUS   Technology Co., Ltd5F,   298-7, Gongdan-ro, Gunpo-si, Gyeonggi-do, 15809, KOREA2023-04-23 变更
31膝关节手术器械包国械备20230244号Blue   Belt Technologies, Inc.76   South Meridian Ave Oklahoma City Oklahoma 73107-6512 USA2023-04-21 有效
32股骨髓腔对线手柄套国械备20152022号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 变更
33骨撬国械备20152018号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 变更
34 骨拉钩国械备20152012号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 变更
35骨锥 国械备20152024号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 变更
36测深器国械备20151879号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 变更
37骨科钻头国械备20152029号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-04-21 变更
38骨铰刀国械备20152028号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-04-21 变更
39牙科种植手术修复工具包国械备20230243号BEGO   Implant Systems GmbH & Co. KGWilhelm-Herbst-Str.   1, 28359 Bremen, Germany2023-04-20 有效
40快接头国械备20230242号Synthes   GmbH4500   Riverside Drive, Palm Beach Gardens, FL 33410, USA2023-04-20 有效
41医用检查手套国械备20150165号Hartalega   Sdn. Bhd.7,   Kawasan Perusahaan Suria, 45600 Bestari Jaya, Selangor Malaysia2023-04-20 变更
42手术剪国械备20230241号Georg   Alber GmbHLindenstrasse   13-78603 Renquishausen Germany2023-04-20 有效
43呼吸训练器国械备20160866号/C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-04-20 变更
44成形片夹国械备20230240号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
45拔牙钳 国械备20230239号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
46口腔麻醉注射架国械备20230238号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
47口腔止血钳国械备20230237号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
48上颌窦内提升器国械备20230236号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
49牙科器械钳 国械备20230235号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
50基础外科用钳国械备20230234号FIRST   CLASS TRADERSP.O.   Box: 1762, Kingra Road, Lageriali, Sialkot-51310-Pakistan2023-04-20 有效
51橡皮障夹钳 国械备20230233号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
52橡皮障支架国械备20230232号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
53橡皮障夹国械备20230231号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
54橡皮障打孔器国械备20230230号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
55牙挺国械备20230229号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
56牙科用镊国械备20230228号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
57正畸钳 国械备20230227号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
58牙科用剪国械备20230226号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
59牙科用牵开器国械备20230225号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
60牙科去冠器 国械备20230224号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
61视力表灯箱国械备20230223号Good-Lite   Company1155   Jansen Farm Drive Elgin, IL 601232023-04-19 有效
62CD5抗体试剂（免疫组织化学）国械备20180756号Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2023-04-18 变更
63阿利辛蓝－过碘酸雪夫氏染色液国械备20230222号Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-18 有效
64吸唾管国械备20160481号Henry   Schein Inc.VIA   DELL'ARTIGIANATO 7-36030 MONTECCHIO PRECALCINO(VI) ITALY2023-04-18 变更
65橡皮障国械备20160823号Henry   Schein Inc.No   16, Persiaran Perindustrian Kanthan 1, Kawansan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia2023-04-18 变更
66医用检查手套国械备20220660号Henry   Schein Inc.189,   Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160, THAILAND2023-04-18 变更
67核酸提取或纯化试剂国械备20180501号BIOMERIEUX   S.A.Centre   Christophe Merieux-5 rue des Berges-38024 GRENOBLE  CEDEX 01-FRANCE2023-04-18 变更
68放射治疗患者用固定装置国械备20140355号Medtec,   LLC dba CIVCO Radiotherapy1401   8th St. SE, Orange City, IA, 51041, United States2023-04-18 变更
69放射治疗患者用固定装置国械备20181007号Medtec,   LLC dba CIVCO Radiotherapy1401   8TH ST. S.E. Orange City, IA USA 510412023-04-18 变更
70正畸自锁托槽开启器国械备20230221号3M   Unitek Corporation3232   N. Rockwell Street, Chicago, IL, 60618, United States2023-04-17 有效
71扭力扳手国械备20140364号Alpha-Bio   Tec Ltd.7   Hatnufa St.,Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel2023-04-17 变更
72牙用尺 国械备20180520号Alpha-Bio   Tec Ltd7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-04-17 变更
73检查手套国械备20170549号Mexpo   International Inc.马来西亚，雪兰州，巴生，奥夫嘉兰马路，巴图5，嘉兰特拉泰，5091地段2023-04-17 变更
74脊柱手术器械国械备20230220号Medos   International SARL见附件。2023-04-17 有效
75脊柱手术器械国械备20210227号Avalign   Technologies, Inc.8727   Clinton Park Dr, Fort Wayne, IN USA 46825; 8414 Clinton Park Dr, Fort Wayne,   IN USA 46825; 626 Cooper Ct, Schaumburg, IL USA 601732023-04-17 变更
76内镜清洗机国械备20220223号STEELCO   SPAVIA   BALEGANTE 27-31039 RIESE PIO X(TV)-Italy2023-04-17 变更
77口镜国械备20230219号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
78牙刮匙国械备20230218号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
79牙科洁治器国械备20230217号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
80牙骨膜分离器国械备20230216号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
81脊柱固定系统手术工具国械备20160103号Pioneer   Surgical Technology,Inc.375   River Park Circle,Marquette,MI 498552023-04-16 无效
82显微镊国械备20150527号FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-14 变更
83清洗脱蜡液国械备20230215号Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
84细胞角蛋白8&18抗体试剂(免疫组织化学)国械备20230214号Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
85 MC抗体试剂（免疫组织化学）国械备20230213号Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
86牙周探针国械备20230212号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
87剔挖器国械备20230211号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
88牙用充填器 国械备20230210号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
89牙探针国械备20230209号Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
90比浊仪国械备20210523号Becton，Dickinson   and Company100   Dayton Avenue, Ames, IA 50010, USA2023-04-14 变更
91CD1a抗体试剂（免疫组织化学）国械备20230208号Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-13 有效
92Smooth   Muscle Myosin抗体试剂（免疫组织化学）国械备20230207号Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-13 有效
93血管钳国械备20150528号FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-13 变更
94咬骨钳国械备20190134号FEHLING   INSTRUMENTS GmbH & Co. KG Hanauer Landstra?e 7A, 63791 Karlstein   Germany2023-04-13 变更
95样本稀释液国械备20191257号Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, MA, 02032, United States2023-04-13 变更
96样本释放剂国械备20191256号Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, MA, 02032, United States2023-04-13 变更
97样本稀释液国械备20160737号Ortho-Clinical   DiagnosticsFelindre   Meadows PENCOED, BRIDGEND CF35 5PZ UNITED KINGDOM2023-04-13 变更
98样本稀释液国械备20150458号Medirox   ABStudsvik,   611 82 NYK?PING, Sweden2023-04-13 变更
99一次性医用丁腈橡胶手套国械备20230206号MEDICAL   GLOVE CO.,LTD288   Moo 7, T.Lam Thap, A.Lam Thap, Krabi 81190 Thailand2023-04-13 有效
100医用橡胶检查手套国械备20230205号MEDICAL   GLOVE CO.,LTD288   Moo 7, T.Lam Thap, A.Lam Thap, Krabi 81190 Thailand2023-04-13 有效
101p120抗体试剂（免疫组织化学）   BOND Ready-to-Use Primary Antibody p120 Catenin (EP66)国械备20190013号Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-04-13 变更
102生物显微镜国械备20220063号株式会社二コン244-8533　日本神奈川県横浜市栄区長尾台町4712023-04-12 变更
103组织染色机国械备20140169号MEDITE   Medical GmbH国械备201401692023-04-12 变更
104轮转式切片机国械备20140038号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2023-04-12 变更
105冷冻切片机 国械备20150255号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2023-04-12 变更
106医用检查手套国械备20230204号HARTALEGA   SDN.BHD.NO.7,KAWASAN   PERUSAHAAN SURIA,45600 2023-04-11 有效
107双移动髋臼杯系统手术工具国械备20230203号SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，FRANCE2023-04-11 有效
108CD43抗体试剂（免疫组织化学）国械备20190634号Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-04-11 变更
109PMS2抗体试剂（免疫组织化学）国械备20210586号 Leica Biosystems Newcastle Ltd Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-04-11 变更
110MSH6抗体试剂（免疫组织化学）国械备20210599号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-04-11 变更
111Mammaglobin抗体试剂（免疫组织化学）BOND   Ready-to-Use Primary Antibody Mammaglobin (EP249)国械备20190014号Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-04-11 变更
112CD103抗体试剂（免疫组织化学法）国械备20191113号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-04-11 变更
113Human   Growth Hormone抗体试剂（免疫组织化学）国械备20190631号Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-04-11 变更
114抗   PRAME（EPR20330)兔单克隆抗体（免疫组织化学法)国械备20230202号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive,  Tucson AZ   85755, USA2023-04-11 有效
115CA   19-9抗体试剂（免疫组织化学） BOND Ready-to-Use Primary Antibody CA19-9 (Sialyl   Lewis<sup>a</sup>) (C241:5:1:4)国械备20190006号Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-04-11 变更
116铲式担架国械备20151329号ME.BER   S.r.l. UnipersonaleVia   Langhirano, 270 l-43124 FONTANINI (PR)2023-04-11 变更
117担架国械备20151328号ME.BER   S.r.l. UnipersonaleVia   Langhirano, 270 l-43124 FONTANINI (PR)2023-04-11 变更
118救护车担架国械备20151325号ME.BER   S.r.l. UnipersonaleVia   Langhirano, 270 l-43124 FONTANINI (PR)2023-04-11 变更
119楼梯担架国械备20151323号ME.BER   S.r.l. UnipersonaleVia   Langhirano, 270 l-43124 FONTANINI (PR)2023-04-11 变更
120吸引管国械备20170144号FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-07 变更
121显微剪国械备20150526号FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-07 变更
122外科牵开器国械备20151609号FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A D-63791 Karlstein2023-04-07 变更
123持针钳国械备20150107号FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-07 变更
124牙科输送头国械备20230201号株式会社松風茨城県笠間市長兎路1320番地52023-04-06 有效
125牙科刮治器国械备20151611号LASCOD   S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)IT-50019   SESTO FIORENTINO (FI)-VIA L.LONGO, 182023-04-06 变更
126种植体清洁刷国械备20190863号Neobiotech   Co., Ltd.102,   103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 608, 10F, 36,   Digital-ro 27-gil, Guro-gu, Seoul/ 104,24, Digital-ro 27-gil, Guro-gu,Seoul/   1F, 60 Gasan digital 2-ro, Geumcheon-gu Seoul, Korea Rep.2023-04-06 变更
127呼吸训练器国械备20150135号/C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-04-06 变更
128骨科手术器械国械备20230200号Synthes   GmbHUnter   Hasslen 5, 78532 Tuttlingen, Germany; Im Bifang 6, 4614 H?gendorf,   Switzerland2023-04-06 有效
129医用检查手套国械备20210120号Supermax   Glove Manufacturing Sdn. Bhd.Lot   38,Putra Industrial Park, Bukit Rahman Putra 47000 Sungai Buloh, Selangor   Darul Ehsan MALAYSIA2023-04-04 变更
130脊柱固定系统手术工具包国械备20160952号Pioneer   Surgical technology,Inc.375   River Park Circle Marquette, Marquette, Michigan, 49855 USA2023-04-04 变更
131牙科骨磨国械备20230199号Storz   am Mark GmbHEmminger   Stra?e 39 78576 Emmingen-Liptingen Germany2023-04-04 有效
132样本稀释液国械备20230198号Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim,Germany2023-04-04 有效
133手术剪国械备20150929号Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany
   
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134骨科固定带国械备20181589号Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2023-04-04 变更
135耳鼻喉用镊国械备20230197号Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4,D-78579 Neuhausen ob Eck, Germany2023-04-04 有效
136耳针国械备20230196号Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4,D-78579 Neuhausen ob Eck, Germany2023-04-04 有效
137牙科手术器械包国械备20180108号DENTSPLY   Implants Manufacturing GmbH见附页。2023-04-04 变更
138显微镊国械备20190406号株式会社高山医療機械製作所東京都台東区谷中3-4-42023-04-03 变更
139医用检查手套国械备20230195号PT   Latexindo TobaperkasaJI.   Binjai Km 11, Mulyorejo – Sunggal 20352, Deli Serdang Indonesia2023-04-03 有效

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