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上月国家局累计批准进口第一类医疗器械备案246项
发布日期:2022-10-21 12:49浏览次数:2878次
国家药监局公布数据,2022年9月,国家药监局累计批准进口第一类医疗器械备案246项,批准数量创年内新高。制造商既有来自欧洲、美国、日本医疗器械主要生产地,亦有来自台湾、马来西亚等区域产品。

国家药监局公布数据,2022年9月,国家药监局累计批准进口第一类医疗器械备案246项,批准数量创年内新高。制造商既有来自欧洲、美国、日本医疗器械主要生产地,亦有来自台湾、马来西亚等区域产品。

进口第一类医疗器械备案.jpg

2022年9月进口第一类医疗器械备案信息

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橡皮障国械备20160823号Henry   Schein Inc.No   16, Persiaran Perindustrian Kanthan 1, Kawansan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia2022-09-30 变更
2质谱样品处理基质国械备20140127号Bruker   Daltonics GmbH & Co. KGFahrenheitstrasse   4,28359 Bremen,Germany2022-09-30 变更
3替代体国械备20200547号Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-09-30 变更
4牙科工具包国械备20220480号TALLADIUM   ESPA?A, S.L.C/   Virginia Woolf, 17 - 25005 LLEIDA, Spain2022-09-30 有效
5龋齿指示剂国械备20160741号Ultradent   Products, Inc.505   West 10200 South, South Jordan, UT 84095, USA2022-09-30 变更
6咬嘴国械备20140232号QuinTron   Instrument Company, Inc.2208   S 38th St Milwaukee, WI 532152022-09-30 变更
7唇颊牵开器国械备20220479号Align   Technology, Inc.Ave.   La Cuspide No.1 Del. Playas de Tijuana, TIJUANA, Baja California Mexico 225002022-09-29 有效
8口腔科手术器械国械备20220478号GUARD   SURGICALDhabula   Near Al-Khidmat Hospital, Sialkot-Pakistan.2022-09-29 有效
9非接触式眼底广角观察镜  国械备20180441号OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar,Germany2022-09-29 变更
10倒像镜及装置 国械备20180442号OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar,Germany2022-09-29 变更
11牙科抛光磨头国械备20190884号EVE   Ernst Vetter GmbHNeureutstra?e   6,75210 Keltern, Germany2022-09-29 无效
12手动推车国械备20170508号Stryker   Medical3800   E. Centre Avenue Portage Michigan 49002 USA2022-09-29 变更
13采血笔国械备20170065号テルモ株式会社山梨県中巨摩郡昭和町築地新居1727-12022-09-29 变更
14颅脑手术头架国械备20220477号Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen,Germany2022-09-29 有效
15软轴牵开器国械备20220476号Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen,Germany2022-09-29 有效
16口腔拉钩国械备20220475号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
17口镜国械备20220474号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
18吸唾管国械备20220473号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
19牙科用凿国械备20220472号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
20增强液国械备20200322号DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany2022-09-29 变更
21剔挖器国械备20220471号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
22牙刮匙国械备20220470号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
23牙用充填器国械备20220469号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
24牙探针国械备20220468号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
25显微眼用剪国械备20151163号D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2022-09-28 变更
26显微眼用镊国械备20151247号D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2022-09-28 变更
27成形片夹国械备20220467号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
28橡皮障打孔器国械备20220466号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
29橡皮障夹国械备20220465号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
30牙科骨充填材料搅拌器国械备20220464号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
31石膏剪国械备20220463号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
32牙科树脂充填器国械备20220462号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
33研光器国械备20220461号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
34牙用测力计国械备20220460号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
35CD45抗体试剂(免疫组织化学)国械备20220459号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-09-28 有效
36Actin抗体试剂(免疫组织化学)国械备20220458号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-09-28 有效
37Synaptophysin抗体试剂(免疫组织化学) 国械备20180262号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-09-28 变更
38CD23抗体试剂(免疫组织化学)国械备20180638号Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-09-28 变更
39造口袋国械备20190931号Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2022-09-27 变更
40医用退热贴国械备20210572号英屬維京群島商凱富企業股份有限公司台灣分公司屏東縣屏東市清溪里和生路三段1006號2022-09-27 变更
41牙科种植定位器国械备20140366号Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936, PetachTikva, 4951025 Israel2022-09-27 变更
42种植体扫描体国械备20181098号MIS   Implants Technologies Ltd.Bar   Lev Industrial Park 2015600, Israel2022-09-27 变更
43牙科种植定位器国械备20180648号 MIS Implants Technologies Ltd. Bar Lev Industrial Park,2015600,Israel2022-09-27 变更
44正畸钳国械备20220457号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-27 有效
45方丝弓成型器国械备20220456号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
46压舌板国械备20220455号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
47拉钩国械备20220454号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
48牙科种植用扳手国械备20220453号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
49牙科用牵开器国械备20220452号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
50口腔麻醉注射架国械备20220451号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
51牙科用刀国械备20220450号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-27 有效
52骨锯国械备20220449号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
53牙科用软组织环切刀国械备20220448号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
54牙科骨磨国械备20220447号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
55种植用骨杯国械备20220446号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
56牙用充填器国械备20220445号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
57牙科输送器国械备20220444号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
58牙科测量尺国械备20220443号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
59橡皮障支架国械备20220442号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
60吸唾管国械备20220441号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
61牙挺国械备20220440号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
62牙科用凿国械备20220439号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
63超声洁牙机工作尖国械备20191244号//2022-09-27 变更
64橡皮障器械国械备20191140号TOP   BM119421,   Россия, г. Москва, ул. Новатров, д. 7А, корп. 22022-09-27 变更
65成形片国械备20181356号TOP   BM119421,   Россия, r. Москва,  ул. Новаторов,   д.7А, корп.22022-09-27 变更
66楔子国械备20181357号TOP   BM119421,   Россия, r. Москва,  ул. Новаторов,   д.7А, корп.22022-09-27 变更
67成形片国械备20181225号TOP   BM119421,   Россия, r. Москва, ул. Новаторов, д.7А, корп.22022-09-27 变更
68打磨抛光清洁器具国械备20220438号EVE   Ernst Vetter GmbHNeureutstra?e   6,75210 Keltern, Germany2022-09-27 有效
69骨科手术器械20190124号CEATEC   Medizintechnik GmbHUntere   Hauptstrasse 6 78573 Wurmlingen, Germany2022-09-27 变更
70吸引贮液瓶国械备20220437号Bemis   Manufacturing CompanyW2940   Old County Road PP Sheboygan Falls , WI 53085 USA2022-09-26 有效
71转移帽国械备20170193号medentis   medical GmbHGartenstr.12,   53507 Dernau, Deutschland2022-09-26 变更
72替代体国械备20181664号medentis   medical GmbHWalporzheimer   Str. 48-52 53474 Bad Neuena hr-Ahrweiler Deutschland2022-09-26 变更
73牙科石膏国械备20171085号SRL   Dental GmbHGiulinistraβe   2 67065 Ludwigshafen Germany2022-09-26 变更
74口腔灯国械备20151288号KaVo   Dental GmbHBismarckring   39 D-88400 Biberach,Germany;    Bahnhofstraβe 20 D-88447 Warthausen,Germany2022-09-26 变更
75口腔观察仪国械备20161762号KaVo   Dental  GmbHBismarckring   39, 88400 Biberach, Germany; Bahnhofstraβe 20, 88447 Warthausen, Germany2022-09-26 变更
76口腔观察仪国械备20151788号Kaltenbach﹠Voigt   GmbHBismarckring   39 D-88400 Biberach,Germany;    Bahnhofstraβe 20 D-88447 Warthausen,Germany2022-09-26 变更
77快接头国械备20190456号KaVo   Dental GmbHBahnhofstra?e   20 88447 Warthausen, Germany2022-09-26 变更
78气动洁牙机工作尖国械备20200502号KaVo   Dental GmbHBahnhofstraβe   20 D-88447 Warthausen2022-09-26 变更
79牙科用镊国械备20220436号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
80牙龈剪国械备20220435号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
81组织镊国械备20220434号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
82眼科镊国械备20220433号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
83根管锉取出器国械备20220432号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
84口镜国械备20220431号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
85根管充填器国械备20220430号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
86牙骨锤国械备20220429号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
87牙科用锉国械备20220428号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
88上颌窦提升器国械备20220427号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
89医用检查手套国械备20190299号A   R MEDICOM (M) SDN BHD3RD   FLOOR, WISMA KOON HOE, NO.3 JALAN 13/3, 46200 PETALING JAYA, SELANGOR DARUL   EHSAN, MALAYSIA2022-09-23 变更
90医用检查手套国械备20181202号A   R Medicom (M) Sdn BhdSuite   807, Block A, Kelana Centre Point, 3, Jalan SS7/19, 47301 Petaling Jaya,   Selangor, MALAYSIA2022-09-23 变更
91清洗液国械备20220426号DiaSorin   Inc.1951   Northwestern Avenue, Stillwater, Minnesota, 55082, USA2022-09-23 有效
92组织染色机国械备20140020号Agilent   Technologies Singapore (International) Pte. Ltd.Bayan   Lepas Free Trade Zone-Phase 3, 11900 Penang, Malaysia 2022-09-22 无效
93口腔治疗器具国械备20210541号MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea2022-09-22 变更
94乳牙成形冠套国械备20220425号(?)??????????   ??? ??? 191 ,1?, 4?2022-09-22 有效
95缓冲液国械备20170256号EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-22 变更
96器械钳国械备20220424号Accuram   InstrumentsStreet   316-C, Small Industrial Estate,Sialkot-51340, Pakistan2022-09-22 有效
97牙科用剪国械备20220423号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
98口腔止血钳国械备20220422号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
99牙科用镊国械备20220421号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
100牙科刮治器国械备20220420号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
101聚酯衬垫国械备20171201号DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-22 变更
102医用外固定支具国械备20161152号DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana2022-09-22 变更
103医用外固定支具国械备20200140号DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL Florido, 22244,Mexico2022-09-22 变更
104可调式固定支具国械备20150118号DJO,   LLC1430   Decision Street Vista, California, 92081, USA2022-09-22 变更
105CD2检测试剂国械备20220419号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
106CD5检测试剂国械备20220418号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
107CD11b检测试剂国械备20220417号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
108CD23检测试剂国械备20220416号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
109CD45RA检测试剂国械备20220415号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
110牙骨凿国械备20170076号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-21 变更
111拔牙钳国械备20160486号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen, Germany2022-09-21 变更
112牙科用咬骨钳国械备20180516号Storz   am Mark GmbHEmminger   Straβe 39 78576 Emmingen-Liptingen Germany2022-09-21 变更
113转移帽国械备20160649号DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal,SWEDEN2022-09-21 变更
114全自动特殊染色机国械备20191429号Agilent   Technologies Singapore (International) Pte Ltd.Bayan  Lepas Free Trade Zone-Phase 3, 11900   Penang, Malaysia2022-09-20 变更
115吸唾组件国械备20220414号DryShield,   LLC11230   Grace Avenue, Suite B Fountain Valley, CA 92708 USA2022-09-20 有效
116牙科用毛刷国械备20170925号Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, Liechtenstein2022-09-20 变更
117医用退热贴 国械备20220413号新タック化成株式会社〒769-1504香川県三豊市豊中町上高野4148番地2022-09-20 有效
118基础外科手术器械国械备20220412号SURGISCAPEJaiser   Wala, Sialkot Road, Daska, Pakistan2022-09-20 有效
119基础外科手术器械国械备20220411号ACCURAY   SURGICALS LIMITED71-A,   Small Industries Estate, Sialkot - Pakistan2022-09-20 有效
120牙探针国械备20161921号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 变更
121口镜国械备20161984号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 变更
122牙科去冠器国械备20180451号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 变更
123牙科刮治器国械备20160644号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen, Germany2022-09-19 变更
124牙挺国械备20160645号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen, Germany2022-09-19 变更
125牙骨锤国械备20170036号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 变更
126牙骨锉国械备20170035号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 变更
127孵育器国械备20160759号DiaMed   GmbH18   avenue du Polygone-42300 ROANNE-France2022-09-19 变更
128医用离心机国械备20160760号DiaMed   GmbH18   avenue du Polygone-42300 ROANNE-France2022-09-19 变更
129神经外科手术工具国械备20200314号MEDTECH   S.A.SZAC   Euréka, 900 rue du Mas de Verchant 34000 MONTPELLIER FRANCE2022-09-19 变更
130成形片国械备20220410号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-19 有效
131组织镊国械备20160731号SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-19 变更
132显微镊国械备20160474号SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-19 变更
133正畸带环就位器国械备20220409号AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-19 有效
134医用检查手套国械备20220408号O&M   Halyard, Inc.200   Moo 8 Kanchanavanich Road, Tambol Prik, Amphur Sadao, Songkhla 90120 Thailand2022-09-19 有效
135胸腔镊国械备20220407号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
136 骨用牵开器国械备20220406号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
137骨膜剥离器国械备20220405号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
138钢丝结扎钳国械备20220404号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
139动脉瘤夹钳国械备20220403号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
140显微钳国械备20220402号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
141颈椎牵开器国械备20220401号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
142外科牵开器国械备20220400号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
143夹持钳国械备20220399号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
144持针钳国械备20220398号Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
145医用外固定支具国械备20171160号DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-16 变更
146口腔冲洗器国械备20170037号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-16 变更
147肩部固定带国械备20210200号DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli El Florido, 22244,Mexico2022-09-16 变更
148医用冰垫国械备20190940号DJO,   LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL Florido, 22244,Mexico2022-09-16 变更
149止血钳国械备20161709号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-16 变更
150牙用充填器国械备20170075号Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-16 变更
151造口袋国械备20190016号アルケア株式会社千葉県千葉市花見川区千種町36-22022-09-16 变更
152造口袋国械备20140361号ァルケァ株式会社289-4   CHIGUSA-CHO, HANAMIGAWA-KU, CHIBA-SHI, CHIBA, JAPAN2022-09-16 变更
153造口袋国械备20190015号アルケア株式会社千葉県千葉市花見川区千種町36-22022-09-16 变更
154弹性医用胶布国械备20140098号ァルケァ株式会社289-4   Chigusa-Cho, Hanamigawa-Ku, Chiba-Shi, Chiba, Japan2022-09-16 变更
155造口皮肤保护剂国械备20190017号アルケア株式会社千葉県千葉市花見川区千種町36-22022-09-16 变更
156造口灌洗器国械备20210041号アルケア株式会社千葉県千葉市花見川区千種町289-42022-09-16 变更
157医用外固定支具国械备20161756号DJO,   LLC1)1430   Decision Street Vista, California, 92081, USA;2)Carretera Libre Tijuana   Tecate #20230 Submetropoli El Florido, Tijuana B. C. Mexico 222442022-09-16 变更
158医用冰垫国械备20150056号DJO,   LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-16 变更
159医用外固定支具国械备20181793号DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, 22244, Mexico2022-09-16 变更
160医用外固定支具国械备20170815号DJO,LLCOrthomerica   Products,Inc.6333 N Orange Blossom Trail, Orlando, Florida 32810 USA 2022-09-16 变更
161医用外固定支具国械备20151493号DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana B.C. Mexico 222442022-09-16 变更
162医用外固定支具国械备20170230号DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-16 变更
163医用外固定支具国械备20151492号DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana B.C. Mexico 222442022-09-16 变更
164踝部固定器国械备20220072号?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2022-09-16 变更
165医用检查手套国械备20220397号Hartalega   NGC Sdn. Bhd.No.1   Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor Darul   Ehsan MALAYSIA2022-09-15 有效
166外科牵开器国械备20180343号TeDan   Surgical Innovations,Inc.12615   W. Airport Blvd, Suite 200, Sugar Land, TX 77478 United States2022-09-15 变更
167扭力扳手国械备20151905号Dentium   Co., Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea2022-09-15 变更
168组织剪国械备20200364号Berger   Surgical Medical Products GmbHKirchstra?e   22, 78532 Tuttlingen, Germany2022-09-15 无效
169髋关节手术工具包国械备20151731号Zimmer   Switzerland Manufacturing GmbHSulzerallee   8, Winterthur, 8404, Switzerland2022-09-15 变更
170替代体国械备20200218号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
171牙科种植用延长器国械备20200208号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
172牙科种植扫描体国械备20200210号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
173种植用牙钻导向器国械备20200211号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
174种植用牙钻限深导向器国械备20200214号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
175种植体螺丝起国械备20200215号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
176牙科种植手术定位件国械备20200216号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
177牙科种植导板国械备20200212号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
178牙科种植扫描体国械备20210008号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
179机动基台螺丝起国械备20200221号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
180牙科种植用扳手国械备20200220号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
181机动种植体螺丝起国械备20200217号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
182扭力扳手国械备20180555号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
183替代体国械备20181224号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
184螺丝起国械备20180559号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
185印模帽国械备20200204号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
186印模转移杆国械备20181259号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
187牙科种植用延长器国械备20181230号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
188印模转移杆国械备20200205号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
189位置定位器国械备20200206号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
190牙科用软组织环切刀国械备20200207号C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 变更
191牙用尺国械备20180554号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
192钻针深度停止器国械备20180545号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
193转移帽国械备20180544号C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 变更
194钙石灰 国械备20151138号Intersurgical   LtdCrane   House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK2022-09-14 变更
195样品后处理系统国械备20220396号醫全實業股份有限公司新北市五股區五權路   34 號 1 樓2022-09-14 有效
196医用护理垫国械备20171084号TORU?SKIE   ZAK?ADY MATERIA?óW OPATRUNKOWYCH S.A.ul.   ?ó?kiewskiego 20/26, 87-100 TORU?, POLAND2022-09-14 变更
197医用检查手套国械备20180210号O&M   Halyard, Inc.Plot   6497-A, Lorong Haji Abdul Manan, 5 3/4 Milestone, Sementa, Jalan Kapar, 42100   Klang, Selangor, Malaysia2022-09-14 变更
198骨科手术器械国械备20220395号Hoogland   Spine Products GmbHFeringastra?e   4, 85774 Unterf?hring, Germany2022-09-13 有效
199手术刀柄国械备20220394号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
200金冠剪国械备20220393号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
201帕巾钳国械备20220392号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
202眼用剪国械备20220391号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
203止血钳国械备20220390号Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
204清洗液国械备20151574号EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-09 变更
205清洗液国械备20151701号EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-09 变更
206穴位压力刺激贴国械备20210607号和光電研株式会社大阪府八尾市太田新町1丁目33番地2022-09-09 变更
207导钻国械备20200599号Stryker   Leibinger GmbH & Co. KG见附件2022-09-09 变更
208骨科手术器械包国械备20170820号Stryker   Leibinger GmbH & Co. KGB?tzinger   Str. 41 79111 Freiburg Deustschland2022-09-09 变更
209骨科导向器国械备20200601号 Stryker Leibinger GmbH & Co. KG ZI   du Moulin Cheyroux - 87700 Aixe-Sur-Vienne - FRANCE2022-09-09 变更
210样本稀释液国械备20151131号Roche   Diagnostics GmbHSandhofer   Strasse 116 , 68305 Mannheim,Germany2022-09-09 变更
211样本稀释液国械备20151715号Roche   Diagnostics GmbHSandhofer   Strasse 116  68305 Mannheim   ,Germany 2022-09-09 变更
212骨科定位器国械备20200600号Stryker   Leibinger GmbH & Co. KG 158   Rue de l’Eglise, 62180 Rang du Flier – France2022-09-09 变更
213骨科牵引架国械备20220389号MAQUET   GmbHKehler   Str. 31, 76437 Rastatt, Germany2022-09-08 有效
214引流管国械备20200267号Dornoch   Medical Systems Inc.200   Nw Parkway Rd Riverside, Mo 64150 USA2022-09-08 变更
215电动石膏锯国械备20220388号HEBUmedical   GmbHBadstra?e   8, 78532 Tuttlingen, GERMANY2022-09-08 有效
216测瓣器 国械备20140239号Medtronic   Inc.1851   E.Deere Avenue, Santa, Ana ,CA 92705, USA2022-09-08 变更
217测瓣器 国械备20160233号Medtronic   Inc.3800   Annapolis Lane, Minneapolis MN 55447, USA2022-09-08 变更
218测瓣器国械备20160470号Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 变更
219测瓣器国械备20160571号Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 变更
220测瓣器国械备20161645号Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 变更
221测瓣器 国械备20161091号Medtronic,   Inc.1)   1851 East Deere Ave. Santa Ana, CA USA 92705; 2)Av. Paseo Cucapah 10510 El   Lago Tijuana, Baja California MEXICO C.P. 222102022-09-08 变更
222担架车国械备20220387号Diacor,Inc.2550   DECKER LAKE BLVD.SUITE 26,West Valley City,UT USA 841192022-09-08 有效
223牙科开口器国械备20210094号Ultradent   Products, Inc.505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2022-09-07 变更
224支撑喉镜国械备20160460号Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-09-07 变更
225牙科手术工具 国械备20161841号ZUGA  MEDICAL, INC. 24400      Chagrin Blvd  Ste  250    Beachwood, OH  441222022-09-05 变更
226种植体扫描体国械备20151682号ZUGA   MEDICAL, INC.24400   CHAGRIN BLVD STE 250 BEACHWOOD, OH USA 441222022-09-05 变更
227牙科种植体手术用工具国械备20160835号Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2022-09-05 变更
228种植体扫描体国械备20151342号Biodenta   Swiss AGTramstr.16   9442 Berneck Switzerland2022-09-05 变更
229替代体国械备20190919号Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2022-09-05 变更
230外科手术固定器械国械备20220386号P   and G Engineering, Incorporated20   MAIN ST., ACTON, MA 017202022-09-02 有效
231医用新生儿床国械备20170669号Stryker   Medical3665   Midlink Drive, Kalamazoo, MI 490482022-09-01 变更
232手动摄影平床国械备20170400号Stryker   Medical 3800   E. Centre Avenue Portage Michigan 49002 USA2022-09-01 变更
233硅橡胶咬合检查材料国械备20191434号//2022-09-01 变更
234正畸钳国械备20160817号Ormco   Corporation1)   1332 South Lone Hill Avenue, Glendora, California,  91740, USA;
   
    2) Circuito Sur No.31, Parque Industrial Nelson, Mexicali, B.C. C.P. 21395,   Mexico
   
    3) Calle Industrial Del Acero No.18, parque Industrial EL Vigia Mexicali,   Baja California Mexico 21397
2022-09-01 变更
235牙科输送头国械备20200401号3M   Deutschland GmbHOhmstra?e   3, 86899 Landsberg, GERMANY2022-09-01 变更
236牙科输送头国械备20200404号3M   Deutschland GmbHRütistrasse   7, CH-9469 Haag2022-09-01 变更
237CD79b检测试剂国械备20220385号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
238CD14检测试剂国械备20220384号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
239CD45RA检测试剂国械备20220383号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
240CD7检测试剂国械备20220382号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
241CD127检测试剂国械备20220381号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
242CD11b检测试剂国械备20220380号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
243血管钳国械备20160732号SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-01 变更
244手术剪 国械备20150597号SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-01 变更
245持针器国械备20150598号SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-01 变更
246肉汤培养基   MH BROTH with 3% LHB国械备20150486号Beckman   Coulter, Inc.1105   North Main Street, Lombard, Illiois 60148, USA2022-09-01 变更

进口第一类医疗器械备案产品备案数据,一方面说明第一类医疗器械产品广泛的临床应用需求,另一方面,境外医疗器械制造企业对我国庞大的医疗器械消费市场的青睐。


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