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上月國家局累計批準進口第一類醫(yī)療器械備案246項
發(fā)布日期:2022-10-21 12:49瀏覽次數(shù):2953次
國家藥監(jiān)局公布數(shù)據(jù),2022年9月,國家藥監(jiān)局累計批準進口第一類醫(yī)療器械備案246項,批準數(shù)量創(chuàng)年內新高。制造商既有來自歐洲、美國、日本醫(yī)療器械主要生產(chǎn)地,亦有來自臺灣、馬來西亞等區(qū)域產(chǎn)品。

國家藥監(jiān)局公布數(shù)據(jù),2022年9月,國家藥監(jiān)局累計批準進口第一類醫(yī)療器械備案246項,批準數(shù)量創(chuàng)年內新高。制造商既有來自歐洲、美國、日本醫(yī)療器械主要生產(chǎn)地,亦有來自臺灣、馬來西亞等區(qū)域產(chǎn)品。

進口第一類醫(yī)療器械備案.jpg

2022年9月進口第一類醫(yī)療器械備案信息

序號產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1橡皮障國械備20160823號Henry   Schein Inc.No   16, Persiaran Perindustrian Kanthan 1, Kawansan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia2022-09-30 變更
2質譜樣品處理基質國械備20140127號Bruker   Daltonics GmbH & Co. KGFahrenheitstrasse   4,28359 Bremen,Germany2022-09-30 變更
3替代體國械備20200547號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-09-30 變更
4牙科工具包國械備20220480號TALLADIUM   ESPA?A, S.L.C/   Virginia Woolf, 17 - 25005 LLEIDA, Spain2022-09-30 有效
5齲齒指示劑國械備20160741號Ultradent   Products, Inc.505   West 10200 South, South Jordan, UT 84095, USA2022-09-30 變更
6咬嘴國械備20140232號QuinTron   Instrument Company, Inc.2208   S 38th St Milwaukee, WI 532152022-09-30 變更
7唇頰牽開器國械備20220479號Align   Technology, Inc.Ave.   La Cuspide No.1 Del. Playas de Tijuana, TIJUANA, Baja California Mexico 225002022-09-29 有效
8口腔科手術器械國械備20220478號GUARD   SURGICALDhabula   Near Al-Khidmat Hospital, Sialkot-Pakistan.2022-09-29 有效
9非接觸式眼底廣角觀察鏡  國械備20180441號OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar,Germany2022-09-29 變更
10倒像鏡及裝置 國械備20180442號OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar,Germany2022-09-29 變更
11牙科拋光磨頭國械備20190884號EVE   Ernst Vetter GmbHNeureutstra?e   6,75210 Keltern, Germany2022-09-29 無效
12手動推車國械備20170508號Stryker   Medical3800   E. Centre Avenue Portage Michigan 49002 USA2022-09-29 變更
13采血筆國械備20170065號テルモ株式會社山梨県中巨摩郡昭和町築地新居1727-12022-09-29 變更
14顱腦手術頭架國械備20220477號Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen,Germany2022-09-29 有效
15軟軸牽開器國械備20220476號Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen,Germany2022-09-29 有效
16口腔拉鉤國械備20220475號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
17口鏡國械備20220474號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
18吸唾管國械備20220473號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
19牙科用鑿國械備20220472號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
20增強液國械備20200322號DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany2022-09-29 變更
21剔挖器國械備20220471號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
22牙刮匙國械備20220470號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
23牙用充填器國械備20220469號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
24牙探針國械備20220468號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
25顯微眼用剪國械備20151163號D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2022-09-28 變更
26顯微眼用鑷國械備20151247號D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2022-09-28 變更
27成形片夾國械備20220467號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
28橡皮障打孔器國械備20220466號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
29橡皮障夾國械備20220465號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
30牙科骨充填材料攪拌器國械備20220464號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
31石膏剪國械備20220463號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
32牙科樹脂充填器國械備20220462號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
33研光器國械備20220461號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
34牙用測力計國械備20220460號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
35CD45抗體試劑(免疫組織化學)國械備20220459號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-09-28 有效
36Actin抗體試劑(免疫組織化學)國械備20220458號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2022-09-28 有效
37Synaptophysin抗體試劑(免疫組織化學) 國械備20180262號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-09-28 變更
38CD23抗體試劑(免疫組織化學)國械備20180638號Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-09-28 變更
39造口袋國械備20190931號Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2022-09-27 變更
40醫(yī)用退熱貼國械備20210572號英屬維京群島商凱富企業(yè)股份有限公司臺灣分公司屏東縣屏東市清溪里和生路三段1006號2022-09-27 變更
41牙科種植定位器國械備20140366號Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936, PetachTikva, 4951025 Israel2022-09-27 變更
42種植體掃描體國械備20181098號MIS   Implants Technologies Ltd.Bar   Lev Industrial Park 2015600, Israel2022-09-27 變更
43牙科種植定位器國械備20180648號 MIS Implants Technologies Ltd. Bar Lev Industrial Park,2015600,Israel2022-09-27 變更
44正畸鉗國械備20220457號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-27 有效
45方絲弓成型器國械備20220456號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
46壓舌板國械備20220455號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
47拉鉤國械備20220454號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
48牙科種植用扳手國械備20220453號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
49牙科用牽開器國械備20220452號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
50口腔麻醉注射架國械備20220451號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
51牙科用刀國械備20220450號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-27 有效
52骨鋸國械備20220449號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
53牙科用軟組織環(huán)切刀國械備20220448號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
54牙科骨磨國械備20220447號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
55種植用骨杯國械備20220446號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
56牙用充填器國械備20220445號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
57牙科輸送器國械備20220444號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
58牙科測量尺國械備20220443號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
59橡皮障支架國械備20220442號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
60吸唾管國械備20220441號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
61牙挺國械備20220440號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
62牙科用鑿國械備20220439號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
63超聲潔牙機工作尖國械備20191244號//2022-09-27 變更
64橡皮障器械國械備20191140號TOP   BM119421,   Россия, г. Москва, ул. Новатров, д. 7А, корп. 22022-09-27 變更
65成形片國械備20181356號TOP   BM119421,   Россия, r. Москва,  ул. Новаторов,   д.7А, корп.22022-09-27 變更
66楔子國械備20181357號TOP   BM119421,   Россия, r. Москва,  ул. Новаторов,   д.7А, корп.22022-09-27 變更
67成形片國械備20181225號TOP   BM119421,   Россия, r. Москва, ул. Новаторов, д.7А, корп.22022-09-27 變更
68打磨拋光清潔器具國械備20220438號EVE   Ernst Vetter GmbHNeureutstra?e   6,75210 Keltern, Germany2022-09-27 有效
69骨科手術器械20190124號CEATEC   Medizintechnik GmbHUntere   Hauptstrasse 6 78573 Wurmlingen, Germany2022-09-27 變更
70吸引貯液瓶國械備20220437號Bemis   Manufacturing CompanyW2940   Old County Road PP Sheboygan Falls , WI 53085 USA2022-09-26 有效
71轉移帽國械備20170193號medentis   medical GmbHGartenstr.12,   53507 Dernau, Deutschland2022-09-26 變更
72替代體國械備20181664號medentis   medical GmbHWalporzheimer   Str. 48-52 53474 Bad Neuena hr-Ahrweiler Deutschland2022-09-26 變更
73牙科石膏國械備20171085號SRL   Dental GmbHGiulinistraβe   2 67065 Ludwigshafen Germany2022-09-26 變更
74口腔燈國械備20151288號KaVo   Dental GmbHBismarckring   39 D-88400 Biberach,Germany;    Bahnhofstraβe 20 D-88447 Warthausen,Germany2022-09-26 變更
75口腔觀察儀國械備20161762號KaVo   Dental  GmbHBismarckring   39, 88400 Biberach, Germany; Bahnhofstraβe 20, 88447 Warthausen, Germany2022-09-26 變更
76口腔觀察儀國械備20151788號Kaltenbach﹠Voigt   GmbHBismarckring   39 D-88400 Biberach,Germany;    Bahnhofstraβe 20 D-88447 Warthausen,Germany2022-09-26 變更
77快接頭國械備20190456號KaVo   Dental GmbHBahnhofstra?e   20 88447 Warthausen, Germany2022-09-26 變更
78氣動潔牙機工作尖國械備20200502號KaVo   Dental GmbHBahnhofstraβe   20 D-88447 Warthausen2022-09-26 變更
79牙科用鑷國械備20220436號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
80牙齦剪國械備20220435號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
81組織鑷國械備20220434號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
82眼科鑷國械備20220433號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
83根管銼取出器國械備20220432號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
84口鏡國械備20220431號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
85根管充填器國械備20220430號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
86牙骨錘國械備20220429號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
87牙科用銼國械備20220428號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
88上頜竇提升器國械備20220427號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
89醫(yī)用檢查手套國械備20190299號A   R MEDICOM (M) SDN BHD3RD   FLOOR, WISMA KOON HOE, NO.3 JALAN 13/3, 46200 PETALING JAYA, SELANGOR DARUL   EHSAN, MALAYSIA2022-09-23 變更
90醫(yī)用檢查手套國械備20181202號A   R Medicom (M) Sdn BhdSuite   807, Block A, Kelana Centre Point, 3, Jalan SS7/19, 47301 Petaling Jaya,   Selangor, MALAYSIA2022-09-23 變更
91清洗液國械備20220426號DiaSorin   Inc.1951   Northwestern Avenue, Stillwater, Minnesota, 55082, USA2022-09-23 有效
92組織染色機國械備20140020號Agilent   Technologies Singapore (International) Pte. Ltd.Bayan   Lepas Free Trade Zone-Phase 3, 11900 Penang, Malaysia 2022-09-22 無效
93口腔治療器具國械備20210541號MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea2022-09-22 變更
94乳牙成形冠套國械備20220425號(?)??????????   ??? ??? 191 ,1?, 4?2022-09-22 有效
95緩沖液國械備20170256號EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-22 變更
96器械鉗國械備20220424號Accuram   InstrumentsStreet   316-C, Small Industrial Estate,Sialkot-51340, Pakistan2022-09-22 有效
97牙科用剪國械備20220423號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
98口腔止血鉗國械備20220422號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
99牙科用鑷國械備20220421號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
100牙科刮治器國械備20220420號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-22 有效
101聚酯襯墊國械備20171201號DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-22 變更
102醫(yī)用外固定支具國械備20161152號DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana2022-09-22 變更
103醫(yī)用外固定支具國械備20200140號DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL Florido, 22244,Mexico2022-09-22 變更
104可調式固定支具國械備20150118號DJO,   LLC1430   Decision Street Vista, California, 92081, USA2022-09-22 變更
105CD2檢測試劑國械備20220419號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
106CD5檢測試劑國械備20220418號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
107CD11b檢測試劑國械備20220417號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
108CD23檢測試劑國械備20220416號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
109CD45RA檢測試劑國械備20220415號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-22 有效
110牙骨鑿國械備20170076號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-21 變更
111拔牙鉗國械備20160486號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen, Germany2022-09-21 變更
112牙科用咬骨鉗國械備20180516號Storz   am Mark GmbHEmminger   Straβe 39 78576 Emmingen-Liptingen Germany2022-09-21 變更
113轉移帽國械備20160649號DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal,SWEDEN2022-09-21 變更
114全自動特殊染色機國械備20191429號Agilent   Technologies Singapore (International) Pte Ltd.Bayan  Lepas Free Trade Zone-Phase 3, 11900   Penang, Malaysia2022-09-20 變更
115吸唾組件國械備20220414號DryShield,   LLC11230   Grace Avenue, Suite B Fountain Valley, CA 92708 USA2022-09-20 有效
116牙科用毛刷國械備20170925號Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, Liechtenstein2022-09-20 變更
117醫(yī)用退熱貼 國械備20220413號新タック化成株式會社〒769-1504香川県三豊市豊中町上高野4148番地2022-09-20 有效
118基礎外科手術器械國械備20220412號SURGISCAPEJaiser   Wala, Sialkot Road, Daska, Pakistan2022-09-20 有效
119基礎外科手術器械國械備20220411號ACCURAY   SURGICALS LIMITED71-A,   Small Industries Estate, Sialkot - Pakistan2022-09-20 有效
120牙探針國械備20161921號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 變更
121口鏡國械備20161984號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 變更
122牙科去冠器國械備20180451號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 變更
123牙科刮治器國械備20160644號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen, Germany2022-09-19 變更
124牙挺國械備20160645號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen, Germany2022-09-19 變更
125牙骨錘國械備20170036號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 變更
126牙骨銼國械備20170035號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-19 變更
127孵育器國械備20160759號DiaMed   GmbH18   avenue du Polygone-42300 ROANNE-France2022-09-19 變更
128醫(yī)用離心機國械備20160760號DiaMed   GmbH18   avenue du Polygone-42300 ROANNE-France2022-09-19 變更
129神經(jīng)外科手術工具國械備20200314號MEDTECH   S.A.SZAC   Euréka, 900 rue du Mas de Verchant 34000 MONTPELLIER FRANCE2022-09-19 變更
130成形片國械備20220410號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-19 有效
131組織鑷國械備20160731號SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-19 變更
132顯微鑷國械備20160474號SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-19 變更
133正畸帶環(huán)就位器國械備20220409號AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-19 有效
134醫(yī)用檢查手套國械備20220408號O&M   Halyard, Inc.200   Moo 8 Kanchanavanich Road, Tambol Prik, Amphur Sadao, Songkhla 90120 Thailand2022-09-19 有效
135胸腔鑷國械備20220407號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
136 骨用牽開器國械備20220406號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
137骨膜剝離器國械備20220405號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
138鋼絲結扎鉗國械備20220404號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
139動脈瘤夾鉗國械備20220403號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
140顯微鉗國械備20220402號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
141頸椎牽開器國械備20220401號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
142外科牽開器國械備20220400號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
143夾持鉗國械備20220399號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
144持針鉗國械備20220398號Karlmed   GmbHCarl-Zeiss-Ring   12  85737 Ismaning Deutschland2022-09-16 有效
145醫(yī)用外固定支具國械備20171160號DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-16 變更
146口腔沖洗器國械備20170037號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-16 變更
147肩部固定帶國械備20210200號DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli El Florido, 22244,Mexico2022-09-16 變更
148醫(yī)用冰墊國械備20190940號DJO,   LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL Florido, 22244,Mexico2022-09-16 變更
149止血鉗國械備20161709號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-16 變更
150牙用充填器國械備20170075號Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-09-16 變更
151造口袋國械備20190016號アルケア株式會社千葉県千葉市花見川區(qū)千種町36-22022-09-16 變更
152造口袋國械備20140361號ァルケァ株式會社289-4   CHIGUSA-CHO, HANAMIGAWA-KU, CHIBA-SHI, CHIBA, JAPAN2022-09-16 變更
153造口袋國械備20190015號アルケア株式會社千葉県千葉市花見川區(qū)千種町36-22022-09-16 變更
154彈性醫(yī)用膠布國械備20140098號ァルケァ株式會社289-4   Chigusa-Cho, Hanamigawa-Ku, Chiba-Shi, Chiba, Japan2022-09-16 變更
155造口皮膚保護劑國械備20190017號アルケア株式會社千葉県千葉市花見川區(qū)千種町36-22022-09-16 變更
156造口灌洗器國械備20210041號アルケア株式會社千葉県千葉市花見川區(qū)千種町289-42022-09-16 變更
157醫(yī)用外固定支具國械備20161756號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 變更
158醫(yī)用冰墊國械備20150056號DJO,   LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-16 變更
159醫(yī)用外固定支具國械備20181793號DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, 22244, Mexico2022-09-16 變更
160醫(yī)用外固定支具國械備20170815號DJO,LLCOrthomerica   Products,Inc.6333 N Orange Blossom Trail, Orlando, Florida 32810 USA 2022-09-16 變更
161醫(yī)用外固定支具國械備20151493號DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana B.C. Mexico 222442022-09-16 變更
162醫(yī)用外固定支具國械備20170230號DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442022-09-16 變更
163醫(yī)用外固定支具國械備20151492號DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana B.C. Mexico 222442022-09-16 變更
164踝部固定器國械備20220072號?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2022-09-16 變更
165醫(yī)用檢查手套國械備20220397號Hartalega   NGC Sdn. Bhd.No.1   Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor Darul   Ehsan MALAYSIA2022-09-15 有效
166外科牽開器國械備20180343號TeDan   Surgical Innovations,Inc.12615   W. Airport Blvd, Suite 200, Sugar Land, TX 77478 United States2022-09-15 變更
167扭力扳手國械備20151905號Dentium   Co., Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea2022-09-15 變更
168組織剪國械備20200364號Berger   Surgical Medical Products GmbHKirchstra?e   22, 78532 Tuttlingen, Germany2022-09-15 無效
169髖關節(jié)手術工具包國械備20151731號Zimmer   Switzerland Manufacturing GmbHSulzerallee   8, Winterthur, 8404, Switzerland2022-09-15 變更
170替代體國械備20200218號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
171牙科種植用延長器國械備20200208號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
172牙科種植掃描體國械備20200210號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
173種植用牙鉆導向器國械備20200211號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
174種植用牙鉆限深導向器國械備20200214號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
175種植體螺絲起國械備20200215號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
176牙科種植手術定位件國械備20200216號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
177牙科種植導板國械備20200212號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
178牙科種植掃描體國械備20210008號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
179機動基臺螺絲起國械備20200221號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
180牙科種植用扳手國械備20200220號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
181機動種植體螺絲起國械備20200217號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
182扭力扳手國械備20180555號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
183替代體國械備20181224號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
184螺絲起國械備20180559號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
185印模帽國械備20200204號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
186印模轉移桿國械備20181259號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
187牙科種植用延長器國械備20181230號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
188印模轉移桿國械備20200205號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
189位置定位器國械備20200206號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
190牙科用軟組織環(huán)切刀國械備20200207號C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
191牙用尺國械備20180554號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
192鉆針深度停止器國械備20180545號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
193轉移帽國械備20180544號C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
194鈣石灰 國械備20151138號Intersurgical   LtdCrane   House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK2022-09-14 變更
195樣品后處理系統(tǒng)國械備20220396號醫(yī)全實業(yè)股份有限公司新北市五股區(qū)五權路   34 號 1 樓2022-09-14 有效
196醫(yī)用護理墊國械備20171084號TORU?SKIE   ZAK?ADY MATERIA?óW OPATRUNKOWYCH S.A.ul.   ?ó?kiewskiego 20/26, 87-100 TORU?, POLAND2022-09-14 變更
197醫(yī)用檢查手套國械備20180210號O&M   Halyard, Inc.Plot   6497-A, Lorong Haji Abdul Manan, 5 3/4 Milestone, Sementa, Jalan Kapar, 42100   Klang, Selangor, Malaysia2022-09-14 變更
198骨科手術器械國械備20220395號Hoogland   Spine Products GmbHFeringastra?e   4, 85774 Unterf?hring, Germany2022-09-13 有效
199手術刀柄國械備20220394號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
200金冠剪國械備20220393號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
201帕巾鉗國械備20220392號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
202眼用剪國械備20220391號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
203止血鉗國械備20220390號Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
204清洗液國械備20151574號EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-09 變更
205清洗液國械備20151701號EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-09 變更
206穴位壓力刺激貼國械備20210607號和光電研株式會社大阪府八尾市太田新町1丁目33番地2022-09-09 變更
207導鉆國械備20200599號Stryker   Leibinger GmbH & Co. KG見附件2022-09-09 變更
208骨科手術器械包國械備20170820號Stryker   Leibinger GmbH & Co. KGB?tzinger   Str. 41 79111 Freiburg Deustschland2022-09-09 變更
209骨科導向器國械備20200601號 Stryker Leibinger GmbH & Co. KG ZI   du Moulin Cheyroux - 87700 Aixe-Sur-Vienne - FRANCE2022-09-09 變更
210樣本稀釋液國械備20151131號Roche   Diagnostics GmbHSandhofer   Strasse 116 , 68305 Mannheim,Germany2022-09-09 變更
211樣本稀釋液國械備20151715號Roche   Diagnostics GmbHSandhofer   Strasse 116  68305 Mannheim   ,Germany 2022-09-09 變更
212骨科定位器國械備20200600號Stryker   Leibinger GmbH & Co. KG 158   Rue de l’Eglise, 62180 Rang du Flier – France2022-09-09 變更
213骨科牽引架國械備20220389號MAQUET   GmbHKehler   Str. 31, 76437 Rastatt, Germany2022-09-08 有效
214引流管國械備20200267號Dornoch   Medical Systems Inc.200   Nw Parkway Rd Riverside, Mo 64150 USA2022-09-08 變更
215電動石膏鋸國械備20220388號HEBUmedical   GmbHBadstra?e   8, 78532 Tuttlingen, GERMANY2022-09-08 有效
216測瓣器 國械備20140239號Medtronic   Inc.1851   E.Deere Avenue, Santa, Ana ,CA 92705, USA2022-09-08 變更
217測瓣器 國械備20160233號Medtronic   Inc.3800   Annapolis Lane, Minneapolis MN 55447, USA2022-09-08 變更
218測瓣器國械備20160470號Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 變更
219測瓣器國械備20160571號Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 變更
220測瓣器國械備20161645號Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 變更
221測瓣器 國械備20161091號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 變更
222擔架車國械備20220387號Diacor,Inc.2550   DECKER LAKE BLVD.SUITE 26,West Valley City,UT USA 841192022-09-08 有效
223牙科開口器國械備20210094號Ultradent   Products, Inc.505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2022-09-07 變更
224支撐喉鏡國械備20160460號Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-09-07 變更
225牙科手術工具 國械備20161841號ZUGA  MEDICAL, INC. 24400      Chagrin Blvd  Ste  250    Beachwood, OH  441222022-09-05 變更
226種植體掃描體國械備20151682號ZUGA   MEDICAL, INC.24400   CHAGRIN BLVD STE 250 BEACHWOOD, OH USA 441222022-09-05 變更
227牙科種植體手術用工具國械備20160835號Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2022-09-05 變更
228種植體掃描體國械備20151342號Biodenta   Swiss AGTramstr.16   9442 Berneck Switzerland2022-09-05 變更
229替代體國械備20190919號Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2022-09-05 變更
230外科手術固定器械國械備20220386號P   and G Engineering, Incorporated20   MAIN ST., ACTON, MA 017202022-09-02 有效
231醫(yī)用新生兒床國械備20170669號Stryker   Medical3665   Midlink Drive, Kalamazoo, MI 490482022-09-01 變更
232手動攝影平床國械備20170400號Stryker   Medical 3800   E. Centre Avenue Portage Michigan 49002 USA2022-09-01 變更
233硅橡膠咬合檢查材料國械備20191434號//2022-09-01 變更
234正畸鉗國械備20160817號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 變更
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236牙科輸送頭國械備20200404號3M   Deutschland GmbHRütistrasse   7, CH-9469 Haag2022-09-01 變更
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進口第一類醫(yī)療器械備案產(chǎn)品備案數(shù)據(jù),一方面說明第一類醫(yī)療器械產(chǎn)品廣泛的臨床應用需求,另一方面,境外醫(yī)療器械制造企業(yè)對我國龐大的醫(yī)療器械消費市場的青睞。


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