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上月國家局累計批準(zhǔn)進(jìn)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):2666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(zhǔn)進(jìn)口第一類醫(yī)療器械備案246項，批準(zhǔn)數(shù)量創(chuàng)年內(nèi)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(zhǔn)進(jìn)口第一類醫(yī)療器械備案246項，批準(zhǔn)數(shù)量創(chuàng)年內(nèi)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(jìn)口第一類醫(yī)療器械備案.jpg

2022年9月進(jìn)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(zhì)譜樣品處理基質(zhì)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(shù)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(shù)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(xué)）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(xué)）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(xué)） 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(xué)）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(shù)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(zhuǎn)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(diào)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
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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
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進(jìn)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(yīng)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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