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2023年2月总局批准进口第一类医疗器械产品备案158个

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来源:飞速度医疗器械咨询  发布时间:2023-06-26  

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2023年3月13日来自国家药监局的消息,药监总局2023年2月共批准进口第一类医疗器械产品备案158个,如医用检查手套、一次性医用丁腈橡胶手套、导引针、高速冷冻离心机、头戴式放大镜、干式激光成像仪、压力绷带等众多产品,详见正文。

第一类医疗器械产品备案.jpg

2023年2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腕部固定系统手术器械国械备20200202号TriMed, Inc.27533 Avenue Hopkins, Santa Clarita, CA 91355, USA2023-02-28变更
2研光器国械备20230127号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
3橡皮障支架国械备20230126号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
4银汞合金输送器国械备20230125号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
5牙科用软组织环切刀国械备20230124号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
6牙骨锉国械备20230123号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
7橡皮障夹钳国械备20230122号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
8橡皮障打孔器国械备20230121号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-28有效
9成形片国械备20170117号Kerr CorporationVia Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-02-28变更
10人工肩关节系统手术器械包国械备20230120号Tornier SAS161 Rue Lavoisier, 38330 Montbonnot-Saint-Martin, FRANCE2023-02-27有效
11口腔科器械国械备20191336号A.Schweickhardt GmbH&Co.KGTuttlinger Stra?e 12 78606 Seitingen / Tuttlingen Germany2023-02-27变更
12牙用充填器国械备20230119号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-24有效
13牙科骨磨国械备20230118号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-24有效
14牙用尺国械备20230117号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-24有效
15牙科输送器国械备20230116号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-24有效
16牙科刮治器 国械备20161891 号株式会社YDM埼玉県東松山市今泉28番地2023-02-24变更
17印模转移杆国械备20190965号SHINHUNG MST CO., LTD.110-2,Donghwagongdan-ro,Munmak-eup,Wonju-si,Gangwon-do,26365,Rep. of KOREA2023-02-24变更
18正畸钳国械备20161162号株式会社YDM埼玉県東松山市今泉28番地2023-02-24变更
19口腔麻醉手动注射架国械备20230115号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-24有效
20牙科骨粉调和用金属容器国械备20230114号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-24有效
21EMA抗体试剂(免疫组织化学)国械备20230113号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-23有效
22bcl-2抗体试剂(免疫组织化学)国械备20230112号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-23有效
23Ber-EP4抗体试剂(免疫组织化学)国械备20230111号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-23有效
24检查手套国械备20181354号B. Braun Melsungen AGLatexx Partners Berhad, Lot 18374, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting, Taiping, Perak, Malaysia2023-02-23无效
25牙科种植用延长器国械备20161072号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
26试戴体国械备20161046号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
27牙科骨挤压器国械备20160935号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
28牙用尺国械备20160516号BioHorizons Implant Systems, Inc.2300 Riverchase Center Birmingham Alabama 35244 USA2023-02-23变更
29螺丝起国械备20161071号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
30基台适配器国械备20170668号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
31种植体内螺纹修复器国械备20161080号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
32牙科用锉国械备20161073号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
33转移帽国械备20161082号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23变更
34种植体旋入止停器国械备20190692号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama, 35244 USA2023-02-23变更
35替代体国械备20190775号BioHorizons Implant Systems, Inc.2300 Riverchase Center, Birmingham, Alabama, 35244 USA2023-02-23变更
36基台夹持器国械备20191276号BioHorizons Implant Systems, Inc.2300 Riverchase Center Birmingham Alabama, 35244 USA2023-02-23变更
37Ber-EP4抗体试剂(免疫组织化学)国械备20230110号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-23有效
38ERG抗体试剂(免疫组织化学)国械备20230109号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-23有效
39医用外固定支具国械备20230108号DJO,LLCNo.143, Sec.2, Zhangxin Rd., Hemei Township, Changhua County 50854, Taiwan (R.O.C.)2023-02-23有效
40导航定位系统工具国械备20230078号Medtronic Navigation, Inc.826 Coal Creek Circle Louisville, CO 80027 United States of America2023-02-23变更
41CD21抗体试剂(免疫组织化学)国械备20230107号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-22有效
42巨细胞病毒抗体试剂(免疫组织化学)国械备20230106号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-22有效
43巨细胞病毒抗体试剂(免疫组织化学)国械备20230105号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-22有效
44CD7抗体试剂(免疫组织化学)国械备20230104号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-22有效
45bcl-6抗体试剂(免疫组织化学)国械备20230103号Agilent Technologies Singapore (International) Pte Ltd.Produktionsvej 42 DK-2600 Glostrup DENMARK2023-02-22有效
46牙科种植材料取出器国械备20151824号Nobel Biocare ABDimbov?gen 2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California 92887 USA;Engvej 33, 3330 G?rl?se, Denmark;74950 SCIONZIER France;Trophagener Weg 25, 32657 Lemgo Deutschland;3233 W. Harvard Street, Santa Ana, California, 92704,USA2023-02-22变更
47牙科用软组织环切刀国械备20151961号Nobel Biocare ABDimbovagen 2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California 92887 USA;Engvej 33, 3330 G?rl?se, Denmark;3233 W. Harvard Street, Santa Ana, California, 92704,USA2023-02-22变更
48牙科器械钳国械备20230102号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-22有效
49截石位手术体位固定架国械备20160606号ALLEN MEDICAL SYSTEMS,INC.100 Discovery Way Acton,MA 017202023-02-22变更
50牙科用镊国械备20230101号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-22有效
51牙科用剪国械备20230100号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-22有效
52硅橡胶复制材料包国械备20210231号DETAX GmbHCarl-Zeiss-Straβe 4, 76275 Ettlingen, Germany2023-02-22变更
53X射线胶片显影液国械备20230099号Carestream Health,Inc.1049 West Ridge Road,Rochester, NY USA 146152023-02-22有效
54X射线胶片显影液和定影液国械备20230098号Caretsream Health,Inc.1049 West Ridge Road,Rochester,NY USA 146152023-02-22有效
55X射线胶片定影液国械备20230097号Carestream Health,Inc.1049 West Ridge Road,Rochester, NY USA 146152023-02-22有效
56拔牙钳国械备20230096号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-22有效
57牙科用牵开器国械备20230095号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-22有效
58牙科用刀国械备20230094号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-22有效
59硅橡胶复制材料国械备20190650号DETAX GmbHCarl-Zeiss-Straβe 4, 76275 Ettlingen, Germany2023-02-21变更
60模型树脂包国械备20190744号DETAX GmbHCarl-Zeiss-Straβe 4, 76275 Ettlingen, Germany2023-02-21变更
61微生物比浊仪国械备20230093号Beckman Coulter, Inc.25 Bradley Drive, Westbrook, Maine 04092, USA2023-02-21有效
62自粘弹力绷带国械备20161076号3M Company601 22nd Ave. South Brookings, South Dakota, 57006, USA2023-02-21变更
63自粘弹力绷带国械备20150894号3M Company3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA2023-02-21变更
64医用退热凝胶国械备20210308号SACRUM ALGAE株式会社東京都足立区梅田六丁目9番6号2023-02-21变更
65人体定位垫国械备20230092号Philips Medical Systems Nederland B.V.Veenpluis 6, 5684 PC Best, The Netherlands2023-02-21有效
66非接触裂隙灯前置镜国械备20210237号VOLK OPTICAL INC.7893 ENTERPRISE DR. Mentor, OH USA 440602023-02-21变更
67种植体清洁刷国械备20200167号光弘生醫科技股份有限公司桃園市蘆竹區內厝里大豐街21號2023-02-20变更
68创伤手术器械包国械备20151190号Zimmer Switzerland Manufacturing GmbHSulzerallee 8, Winterthur, 8404, Switzerland2023-02-20变更
69肱骨髓内钉手术工具国械备20210174号Zimmer Switzerland Manufacturing GmbHSulzerallee 8, Winterthur 8404 Switzerland2023-02-20变更
70手术托架国械备20220036号ミズホ株式会社新潟県五泉市赤海3631番14,千葉県佐倉市太田2173番地132023-02-17变更
71腹腔用拉钩装置器国械备20160311号Max Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e 33,78532 Tuttlingen Germany2023-02-17变更
72牙科骨磨国械备20230091号A.Schweickhardt GmbH & Co.KGTuttlinger Stra?e 12 78606 Seitingen/ Tuttlingen Germany2023-02-17有效
73注射器辅助推进枪国械备20230090号Owen Mumford LimitedPrimsdown Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire,OX7 5XP, United Kingdom2023-02-17有效
74药敏接种培养液国械备20230089号Remel, Inc12076 Santa Fe Trail Drive Lenexa Kansas 66215 USA2023-02-16有效
75肉汤培养基国械备20230088号Remel, Inc12076 Santa Fe Trail Drive Lenexa Kansas 66215 USA2023-02-16有效
76清洗液国械备 20170375号EKF-diagnostic GmbHEbendorfer Chaussee 3, 39179 Barleben, GERMANY2023-02-16变更
77样本稀释液国械备20150741号Wallac OyMustionkatu 6, FI-20750 Turku, Finland2023-02-16无效
78上肢医用外固定支具国械备20170269号?ssur hf.Grjotháls 1-5 Reykjavik 110 Iceland2023-02-15变更
79粪便检验预处理装置国械备20151619号EIKEN CHEMICAL CO., LTD.3585, Kando, Yoshida-cho, Haibara-gun, Shizuoka, 421-0304 JAPAN2023-02-15变更
80骨科手术器械国械备20191138号Limacorporate S.p.A.Via Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY2023-02-15变更
81医用检查手套国械备20230087号UG GLOBAL RESOURCES SDN. BHD.Lot 62 & 63, Lorong Senawang 3/2,Kawasan Perindustrian Senawang, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia2023-02-15有效
82医用支撑腿架国械备20230086号MAQUET GmbHKehler Straβe 31, 76437 Rastatt, Germany2023-02-14有效
83手术剪国械备20230085号Berger Surgical Medical Products GmbHTake-off-Gewerbepark 4 D-78579 Neuhausen ob Eck2023-02-14有效
84肛门镜国械备20230084号Berger Surgical Medical Products GmbHTake-off-Gewerbepark 4 D-78579 Neuhausen ob Eck2023-02-14有效
85外耳道扩张器国械备20230083号Berger Surgical Medical Products GmbHTake-off-Gewerbepark 4 D-78579 Neuhausen ob Eck2023-02-14有效
86压板国械备20230082号Berger Surgical Medical Products GmbHTake-off-Gewerbepark 4 D-78579 Neuhausen ob Eck2023-02-14有效
87种植辅助器械包国械备20180112号ALTATEC GmbHMaybachstr. 5,71299 Wimsheim, Germany2023-02-13变更
88牙科模型材料国械备20161677号ALTATEC GmbHMaybachstr.5, 71299 Wimsheim, GERMANY2023-02-13变更
89转移帽国械备20180208号ALTATEC GmbHMaybachstr. 5,71299 Wimsheim, Germany2023-02-13变更
90种植体安装辅助器械国械备20190350号ALTATEC GmbHMaybachstr. 5, 71299 Wimsheim, GERMANY2023-02-13变更
91种植体安装辅助器械国械备20180987号ALTATEC GmbHMaybachstr. 5, 71299 Wimsheim, Germany2023-02-13变更
92牙科种植辅助器械包国械备20180988号ALTATEC GmbHMaybachstr. 5, 71299 Wimsheim, Germany2023-02-13变更
93种植辅助材料国械备20181551号ALTATEC GmbHMaybachstr. 5, 71299 Wimsheim, GERMANY2023-02-13变更
94牙科骨挤压器国械备20170960号ALTATEC GmbHMaybachstr. 5,71299 Wimsheim, Germany2023-02-13变更
95夹板及固定带国械备20190059号VAR?TEKS ORTOPED? SANAY? A.?.Maltepe Mah, Aile Bah?e Sok., Litros Yolu, No: 10, 34010, Zeytinburnu, ?stanbul, Turkey2023-02-13变更
96踝部固定器国械备20230081号PAVIS S.P.A.Via G.Rossini, 11/B - 21020 Buguggiate (VA), Italy2023-02-10有效
97麦氏比浊计国械备20220077号Trek Diagnostic Systems LtdViking House Ellingham Way Ashford TN23 6NF United Kingdom2023-02-10变更
98髋关节手术器械国械备20151787号Smith & Nephew,Inc1450 Brooks Road, Memphis, Tennessee, 38116, USA;

Alemannenstraβe 14, D-78532, Tuttlingen, 78532, Germany;

2 lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, 11920 Bayan Lepas, Penang, MALAYSIA;

Schachenallee 29, 5001 Aarau, SWITZERLAND;

Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C. 22444, Mexico.

2023-02-09变更
99小骨关节植入物手术器械包国械备20160867号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
100空心加压螺钉系统手术器械包国械备20160475号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
101足踝系统用手术器械包国械备20161099号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
102骨折固定系统手术器械包国械备20160931号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
103足踝钉板系统用手术器械包国械备20191102号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
104模型树脂国械备20180695号VERICOM CO., LTD48,Toegyegongdan 1-gil,Chuncheon-si, Gangwon-do, 200-944,Republic of KOREA2023-02-09变更
105骨铰刀国械备20191045号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
106足踝钉板系统手术器械包国械备20190267号Wright Medical Technology, Inc11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
107足踝髓内钉系统手术器械包国械备20161201号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
108全踝关节手术器械包国械备20161100号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
109压力绷带国械备20230080号SIGVARIS Inc.13055 Riley St., Suite 30 Holland, Michigan 49424 USA2023-02-09有效
110肘关节手术器械包国械备20160724号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
111压力绷带国械备20230079号SIGVARIS Inc.13055 Riley St., Suite 30 Holland, Michigan 49424 USA2023-02-09有效
112全踝关节手术器械包国械备20191444号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
113骨铰刀国械备20191100号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
114全踝关节手术器械包国械备20200188号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
115骨科定位片国械备20191061号Wright Medical Technology, Inc.11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09变更
116导航定位系统工具国械备20230078号Medtronic Navigation, Inc.826 Coal Creek Circle Louisville, CO 80027 United States of America2023-02-09有效
117超声探头穿刺架国械备20230077号GE ヘルスケア?ジャパン株式会社〒191-8503 東京都日野市旭が丘 4-7-1272023-02-08有效
118牙科橡皮障楔线国械备20160116号Dent4You AG235 Ascot Parkway Cuyahoga Falls, OH 44223 United States of America2023-02-08变更
119骨科手术器械国械备20191433号Limacorporate S.p.A.Via Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY2023-02-08变更
120骨科手术器械国械备20200331号HPF S.r.l.Via Pinzano, 24 - 33030 Flagogna di Forgaria nel Friuli (UD) - Italy2023-02-08变更
121下肢医用外固定支具国械备20150418号Breg Inc.Calzada Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California, Mexico2023-02-08变更
122上肢医用外固定支具国械备20150417号Breg Inc.Calzada Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California, Mexico2023-02-08变更
123踝部固定器国械备20180276号Breg Inc见附件2023-02-08变更
124医用外固定支具国械备20180274号Breg IncCalzada Presidnte Venustiano Carrnza #33, C.p.21385, Mexicali, Baja California, Mexico.2023-02-08变更
125橡皮障支架国械备20160478号Dent4You AG235 Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-07变更
126橡皮障打孔器国械备20160375号Dent4You AG235 Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-07变更
127牙刮匙国械备20230076号ASA DENTAL SPAVIA FIERLA 13-33085 MANIAGO (PN)2023-02-07有效
128医用弹力贴布国械备20191353号ニチバン株式会社日本福岡県朝倉郡筑前町野町字禅門橋17132023-02-06变更
129妇产科手术器械国械备20200043号DELMONT IMAGING390 Avenue du Mistral, 13600 La Ciotat, France2023-02-06变更
130橡皮障夹钳国械备20160376号Dent4You AG235 Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-06变更
131橡皮障夹国械备20151720号Dent4You AG235 Ascot Parkway Cuyahoga Falls, OH 44223 United States of America2023-02-06变更
132口腔科手术器械国械备20230075号ASAS AND BROTHERS ENTERPRISESMODEL TOWN,UGOKI,SIALKOT,PAKISTAN2023-02-06有效
133异硫氰酸荧光素(FITC)标记的兔抗人C3c(含伊文氏兰)国械备20200399号EUROIMMUN Medizinische Labordiagnostika AGWerkstraβe 1, 23942 Dassow, Germany2023-02-06变更
134异硫氰酸荧光素(FITC)标记的羊抗人IgG(含碘化丙啶)国械备20200400号EUROIMMUN Medizinische Labordiagnostika AGWerkstraβe 1, 23942 Dassow, Germany2023-02-06变更
135异硫氰酸荧光素(FITC)标记的羊抗人IgM(含伊文氏兰)国械备20200398号EUROIMMUN Medizinische Labordiagnostika AGWerkstraβe 1, 23942 Dassow, Germany2023-02-06变更
136干式激光成像仪国械备20151260号コニカミノルタ株式会社埼玉県狭山市広瀬台二丁目2番1号 2-2-1, Hirosedai,Sayama-shi,Saitama2023-02-06变更
137干式激光成像仪国械备20170398号コニカミノルタ株式会社1 Sakura-machi,Hino-shi,Tokyo,Japan;2-2-1, Hirosedai,Sayama-shi,Saitama,Japan2023-02-06变更
138医用检查手套国械备20230074号GLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia.2023-02-06有效
139止血钳国械备20150031号Max Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e 33,78532 Tuttlingen Germany2023-02-03变更
140超声洁牙机工作尖国械备20191244号//2023-02-03变更
141医用干式银盐胶片国械备20230073号AGFA NVSeptestraat 27, 2640 Mortsel , Belgium 1658 Bushy Park Road, Goose Creek, South Carolina 29445, USA2023-02-03有效
142高速冷冻离心机国械备20150368号Thermo Electron LED GmbH Zweigniederlassung OsterodeAm Kalkberg, 37520 Osterode am Harz, Germany2023-02-03变更
143种植辅助材料国械备20230072号A.B. Dental Devices Ltd.19 Hayahalomim Street Ashdod 7761117 Israel2023-02-03有效
144药敏接种培养液国械备20140220号Remel, Inc12076 Santa Fe Trail Drive , Lenexa, Kansas 66215, USA2023-02-02变更
145头戴式放大镜国械备20162018号Metrex Research LLC dba Orascoptic3225 Deming Way Suite 190 Middleton Wisconsin 53562 USA2023-02-02变更
146CD36检测试剂国械备20230071号BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-02-02有效
147CD71检测试剂国械备20230070号BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-02-02有效
148虹膜拉钩国械备20181048号MICROSURGICAL TECHNOLOGY, INC.8415 154th Ave Ne Redmond, WA 980522023-02-02变更
149导引针国械备20171015号Boston Scientific Corporation10700 Bren Road West, Minnetonka, MN USA 553432023-02-01变更
150器械钳国械备20171065号Boston Scientific Corporation10700 Bren Road West, Minnetonka, MN USA 553432023-02-01变更
151削切刀国械备20151269号Gebr. Brasseler GmbH & Co. KGTrophagener Weg 25 32657 Lemgo Deutschland2023-02-01无效
152骨铰刀国械备20150482号Gebr. Brasseler GmbH & Co. KGTrophagener Weg 25 32657 Lemgo Deutschland2023-02-01无效
153锯片国械备20151270号Gebr. Brasseler GmbH & Co. KGTrophagener Weg 25 32657 Lemgo Deutschland2023-02-01无效
154一次性医用丁腈橡胶手套国械备20230069号GLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia.2023-02-01有效
155医用检查手套国械备20230068号GLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia.2023-02-01有效
156成像板暗盒国械备20170460号コニカミノルタ株式会社日本国東京都日野市さくら町1番地;日本国埼玉県狭山市広瀬台2-2-12023-02-27无效
157成像板暗盒国械备20170461号コニカミノルタ株式会社日本国東京都日野市さくら町1番地;日本国埼玉県狭山市広瀬台2-2-12023-02-27无效
158检查手套国械备20151388号B. Braun Melsungen AG110 Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-02-23无效

众多进口第一类医疗器械产品备案获批,也说明第一类医疗器械产品在国内也有大的市场,也说明生产第一类医疗器械还有许多机会。


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