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上月國(guó)家局累計(jì)批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械備案246項(xiàng)
發(fā)布日期:2022-10-21 12:49瀏覽次數(shù):2667次
國(guó)家藥監(jiān)局公布數(shù)據(jù)，2022年9月，國(guó)家藥監(jiān)局累計(jì)批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械備案246項(xiàng)，批準(zhǔn)數(shù)量創(chuàng)年內(nèi)新高。制造商既有來(lái)自歐洲、美國(guó)、日本醫(yī)療器械主要生產(chǎn)地，亦有來(lái)自臺(tái)灣、馬來(lái)西亞等區(qū)域產(chǎn)品。

國(guó)家藥監(jiān)局公布數(shù)據(jù)，2022年9月，國(guó)家藥監(jiān)局累計(jì)批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械備案246項(xiàng)，批準(zhǔn)數(shù)量創(chuàng)年內(nèi)新高。制造商既有來(lái)自歐洲、美國(guó)、日本醫(yī)療器械主要生產(chǎn)地，亦有來(lái)自臺(tái)灣、馬來(lái)西亞等區(qū)域產(chǎn)品。

進(jìn)口第一類(lèi)醫(yī)療器械備案.jpg

2022年9月進(jìn)口第一類(lèi)醫(yī)療器械備案信息

序號(hào)產(chǎn)品名稱(chēng)備案號(hào)備案人名稱(chēng)原文生產(chǎn)地址原文備案日期狀態(tài)
1橡皮障國(guó)械備20160823號(hào)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(guó)械備20140127號(hào)Bruker   Daltonics GmbH & Co. KGFahrenheitstrasse   4,28359 Bremen,Germany2022-09-30 變更
3替代體國(guó)械備20200547號(hào)Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-09-30 變更
4牙科工具包國(guó)械備20220480號(hào)TALLADIUM   ESPA?A, S.L.C/   Virginia Woolf, 17 - 25005 LLEIDA, Spain2022-09-30 有效
5齲齒指示劑國(guó)械備20160741號(hào)Ultradent   Products, Inc.505   West 10200 South, South Jordan, UT 84095, USA2022-09-30 變更
6咬嘴國(guó)械備20140232號(hào)QuinTron   Instrument Company, Inc.2208   S 38th St Milwaukee, WI 532152022-09-30 變更
7唇頰牽開(kāi)器國(guó)械備20220479號(hào)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(guó)械備20220478號(hào)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(guó)械備20180441號(hào)OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar，Germany2022-09-29 變更
10倒像鏡及裝置 國(guó)械備20180442號(hào)OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar，Germany2022-09-29 變更
11牙科拋光磨頭國(guó)械備20190884號(hào)EVE   Ernst Vetter GmbHNeureutstra?e   6,75210 Keltern, Germany2022-09-29 無(wú)效
12手動(dòng)推車(chē)國(guó)械備20170508號(hào)Stryker   Medical3800   E. Centre Avenue Portage Michigan 49002 USA2022-09-29 變更
13采血筆國(guó)械備20170065號(hào)テルモ株式會(huì)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(guó)械備20220477號(hào)Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen,Germany2022-09-29 有效
15軟軸牽開(kāi)器國(guó)械備20220476號(hào)Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen,Germany2022-09-29 有效
16口腔拉鉤國(guó)械備20220475號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
17口鏡國(guó)械備20220474號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
18吸唾管國(guó)械備20220473號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
19牙科用鑿國(guó)械備20220472號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-29 有效
20增強(qiáng)液國(guó)械備20200322號(hào)DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany2022-09-29 變更
21剔挖器國(guó)械備20220471號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
22牙刮匙國(guó)械備20220470號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
23牙用充填器國(guó)械備20220469號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
24牙探針國(guó)械備20220468號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-28 有效
25顯微眼用剪國(guó)械備20151163號(hào)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(guó)械備20151247號(hào)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(guó)械備20220467號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
28橡皮障打孔器國(guó)械備20220466號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
29橡皮障夾國(guó)械備20220465號(hào)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(guó)械備20220464號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
31石膏剪國(guó)械備20220463號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
32牙科樹(shù)脂充填器國(guó)械備20220462號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
33研光器國(guó)械備20220461號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-28 有效
34牙用測(cè)力計(jì)國(guó)械備20220460號(hào)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(guó)械備20220459號(hào)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(guó)械備20220458號(hào)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(guó)械備20180262號(hào)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(guó)械備20180638號(hào)Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-09-28 變更
39造口袋國(guó)械備20190931號(hào)Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2022-09-27 變更
40醫(yī)用退熱貼國(guó)械備20210572號(hào)英屬維京群島商凱富企業(yè)股份有限公司臺(tái)灣分公司屏東縣屏東市清溪里和生路三段1006號(hào)2022-09-27 變更
41牙科種植定位器國(guó)械備20140366號(hào)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(guó)械備20181098號(hào)MIS   Implants Technologies Ltd.Bar   Lev Industrial Park 2015600, Israel2022-09-27 變更
43牙科種植定位器國(guó)械備20180648號(hào) MIS Implants Technologies Ltd. Bar Lev Industrial Park,2015600,Israel2022-09-27 變更
44正畸鉗國(guó)械備20220457號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-27 有效
45方絲弓成型器國(guó)械備20220456號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
46壓舌板國(guó)械備20220455號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
47拉鉤國(guó)械備20220454號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
48牙科種植用扳手國(guó)械備20220453號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
49牙科用牽開(kāi)器國(guó)械備20220452號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
50口腔麻醉注射架國(guó)械備20220451號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
51牙科用刀國(guó)械備20220450號(hào)AOYA   HYDROJET INSTRUMENT PREM   NAGER ROAD,SILVER STAR CHOCK,SIALKOT 51310 ,PAKISTAN2022-09-27 有效
52骨鋸國(guó)械備20220449號(hào)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(guó)械備20220448號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
54牙科骨磨國(guó)械備20220447號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
55種植用骨杯國(guó)械備20220446號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
56牙用充填器國(guó)械備20220445號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
57牙科輸送器國(guó)械備20220444號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
58牙科測(cè)量尺國(guó)械備20220443號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
59橡皮障支架國(guó)械備20220442號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
60吸唾管國(guó)械備20220441號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
61牙挺國(guó)械備20220440號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
62牙科用鑿國(guó)械備20220439號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-27 有效
63超聲潔牙機(jī)工作尖國(guó)械備20191244號(hào)//2022-09-27 變更
64橡皮障器械國(guó)械備20191140號(hào)TOP   BM119421,   Россия, г. Москва, ул. Новатров, д. 7А, корп. 22022-09-27 變更
65成形片國(guó)械備20181356號(hào)TOP   BM119421,   Россия, r. Москва,  ул. Новаторов,   д.7А, корп.22022-09-27 變更
66楔子國(guó)械備20181357號(hào)TOP   BM119421,   Россия, r. Москва,  ул. Новаторов,   д.7А, корп.22022-09-27 變更
67成形片國(guó)械備20181225號(hào)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(guó)械備20220438號(hào)EVE   Ernst Vetter GmbHNeureutstra?e   6,75210 Keltern, Germany2022-09-27 有效
69骨科手術(shù)器械20190124號(hào)CEATEC   Medizintechnik GmbHUntere   Hauptstrasse 6 78573 Wurmlingen, Germany2022-09-27 變更
70吸引貯液瓶國(guó)械備20220437號(hào)Bemis   Manufacturing CompanyW2940   Old County Road PP Sheboygan Falls , WI 53085 USA2022-09-26 有效
71轉(zhuǎn)移帽國(guó)械備20170193號(hào)medentis   medical GmbHGartenstr.12,   53507 Dernau, Deutschland2022-09-26 變更
72替代體國(guó)械備20181664號(hào)medentis   medical GmbHWalporzheimer   Str. 48-52 53474 Bad Neuena hr-Ahrweiler Deutschland2022-09-26 變更
73牙科石膏國(guó)械備20171085號(hào)SRL   Dental GmbHGiulinistraβe   2 67065 Ludwigshafen Germany2022-09-26 變更
74口腔燈國(guó)械備20151288號(hào)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(guó)械備20161762號(hào)KaVo   Dental  GmbHBismarckring   39, 88400 Biberach, Germany; Bahnhofstraβe 20, 88447 Warthausen, Germany2022-09-26 變更
76口腔觀察儀國(guó)械備20151788號(hào)Kaltenbach﹠Voigt   GmbHBismarckring   39 D-88400 Biberach,Germany;    Bahnhofstraβe 20 D-88447 Warthausen,Germany2022-09-26 變更
77快接頭國(guó)械備20190456號(hào)KaVo   Dental GmbHBahnhofstra?e   20 88447 Warthausen, Germany2022-09-26 變更
78氣動(dòng)潔牙機(jī)工作尖國(guó)械備20200502號(hào)KaVo   Dental GmbHBahnhofstraβe   20 D-88447 Warthausen2022-09-26 變更
79牙科用鑷國(guó)械備20220436號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
80牙齦剪國(guó)械備20220435號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
81組織鑷國(guó)械備20220434號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
82眼科鑷國(guó)械備20220433號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
83根管銼取出器國(guó)械備20220432號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
84口鏡國(guó)械備20220431號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
85根管充填器國(guó)械備20220430號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
86牙骨錘國(guó)械備20220429號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
87牙科用銼國(guó)械備20220428號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
88上頜竇提升器國(guó)械備20220427號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-23 有效
89醫(yī)用檢查手套國(guó)械備20190299號(hào)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(guó)械備20181202號(hào)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(guó)械備20220426號(hào)DiaSorin   Inc.1951   Northwestern Avenue, Stillwater, Minnesota, 55082, USA2022-09-23 有效
92組織染色機(jī)國(guó)械備20140020號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Bayan   Lepas Free Trade Zone-Phase 3, 11900 Penang, Malaysia 2022-09-22 無(wú)效
93口腔治療器具國(guó)械備20210541號(hào)MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea2022-09-22 變更
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165醫(yī)用檢查手套國(guó)械備20220397號(hào)Hartalega   NGC Sdn. Bhd.No.1   Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor Darul   Ehsan MALAYSIA2022-09-15 有效
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171牙科種植用延長(zhǎng)器國(guó)械備20200208號(hào)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(guó)械備20200210號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
173種植用牙鉆導(dǎo)向器國(guó)械備20200211號(hào)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(dǎo)向器國(guó)械備20200214號(hào)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(guó)械備20200215號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
176牙科種植手術(shù)定位件國(guó)械備20200216號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
177牙科種植導(dǎo)板國(guó)械備20200212號(hào)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(guó)械備20210008號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
179機(jī)動(dòng)基臺(tái)螺絲起國(guó)械備20200221號(hào)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(guó)械備20200220號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
181機(jī)動(dòng)種植體螺絲起國(guó)械備20200217號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
182扭力扳手國(guó)械備20180555號(hào)C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
183替代體國(guó)械備20181224號(hào)C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
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185印模帽國(guó)械備20200204號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
186印模轉(zhuǎn)移桿國(guó)械備20181259號(hào)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(zhǎng)器國(guó)械備20181230號(hào)C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
188印模轉(zhuǎn)移桿國(guó)械備20200205號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
189位置定位器國(guó)械備20200206號(hào)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(guó)械備20200207號(hào)C-TECH   IMPLANT SRLVia   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2022-09-14 變更
191牙用尺國(guó)械備20180554號(hào)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(guó)械備20180545號(hào)C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
193轉(zhuǎn)移帽國(guó)械備20180544號(hào)C-TECH   IMPLANT SRLVia   S. Benedetto, 1837, 40018 S. Pietro in Casale (BO), ITALY2022-09-14 變更
194鈣石灰 國(guó)械備20151138號(hào)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(guó)械備20220396號(hào)醫(yī)全實(shí)業(yè)股份有限公司新北市五股區(qū)五權(quán)路   34 號(hào) 1 樓2022-09-14 有效
196醫(yī)用護(hù)理墊國(guó)械備20171084號(hào)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(guó)械備20180210號(hào)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(shù)器械國(guó)械備20220395號(hào)Hoogland   Spine Products GmbHFeringastra?e   4, 85774 Unterf?hring, Germany2022-09-13 有效
199手術(shù)刀柄國(guó)械備20220394號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
200金冠剪國(guó)械備20220393號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
201帕巾鉗國(guó)械備20220392號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
202眼用剪國(guó)械備20220391號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
203止血鉗國(guó)械備20220390號(hào)Majestic   InstrumentsOpposite   Masjid Tajdary Madina, Shahab Pura Road, Sialkot - Pakistan2022-09-13 有效
204清洗液國(guó)械備20151574號(hào)EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-09 變更
205清洗液國(guó)械備20151701號(hào)EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2022-09-09 變更
206穴位壓力刺激貼國(guó)械備20210607號(hào)和光電研株式會(huì)社大阪府八尾市太田新町1丁目33番地2022-09-09 變更
207導(dǎo)鉆國(guó)械備20200599號(hào)Stryker   Leibinger GmbH & Co. KG見(jiàn)附件2022-09-09 變更
208骨科手術(shù)器械包國(guó)械備20170820號(hào)Stryker   Leibinger GmbH & Co. KGB?tzinger   Str. 41 79111 Freiburg Deustschland2022-09-09 變更
209骨科導(dǎo)向器國(guó)械備20200601號(hào) 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(guó)械備20151131號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116 , 68305 Mannheim，Germany2022-09-09 變更
211樣本稀釋液國(guó)械備20151715號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116  68305 Mannheim   ,Germany 2022-09-09 變更
212骨科定位器國(guó)械備20200600號(hào)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(guó)械備20220389號(hào)MAQUET   GmbHKehler   Str. 31, 76437 Rastatt, Germany2022-09-08 有效
214引流管國(guó)械備20200267號(hào)Dornoch   Medical Systems Inc.200   Nw Parkway Rd Riverside, Mo 64150 USA2022-09-08 變更
215電動(dòng)石膏鋸國(guó)械備20220388號(hào)HEBUmedical   GmbHBadstra?e   8, 78532 Tuttlingen, GERMANY2022-09-08 有效
216測(cè)瓣器 國(guó)械備20140239號(hào)Medtronic   Inc.1851   E.Deere Avenue, Santa, Ana ,CA 92705, USA2022-09-08 變更
217測(cè)瓣器 國(guó)械備20160233號(hào)Medtronic   Inc.3800   Annapolis Lane, Minneapolis MN 55447, USA2022-09-08 變更
218測(cè)瓣器國(guó)械備20160470號(hào)Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 變更
219測(cè)瓣器國(guó)械備20160571號(hào)Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 變更
220測(cè)瓣器國(guó)械備20161645號(hào)Medtronic   Inc.1851   E. Deere Avenue, Santa Ana, CA92705, USA2022-09-08 變更
221測(cè)瓣器 國(guó)械備20161091號(hào)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(dān)架車(chē)國(guó)械備20220387號(hào)Diacor,Inc.2550   DECKER LAKE BLVD.SUITE 26,West Valley City,UT USA 841192022-09-08 有效
223牙科開(kāi)口器國(guó)械備20210094號(hào)Ultradent   Products, Inc.505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2022-09-07 變更
224支撐喉鏡國(guó)械備20160460號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-09-07 變更
225牙科手術(shù)工具 國(guó)械備20161841號(hào)ZUGA  MEDICAL, INC. 24400      Chagrin Blvd  Ste  250    Beachwood, OH  441222022-09-05 變更
226種植體掃描體國(guó)械備20151682號(hào)ZUGA   MEDICAL, INC.24400   CHAGRIN BLVD STE 250 BEACHWOOD, OH USA 441222022-09-05 變更
227牙科種植體手術(shù)用工具國(guó)械備20160835號(hào)Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2022-09-05 變更
228種植體掃描體國(guó)械備20151342號(hào)Biodenta   Swiss AGTramstr.16   9442 Berneck Switzerland2022-09-05 變更
229替代體國(guó)械備20190919號(hào)Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2022-09-05 變更
230外科手術(shù)固定器械國(guó)械備20220386號(hào)P   and G Engineering, Incorporated20   MAIN ST., ACTON, MA 017202022-09-02 有效
231醫(yī)用新生兒床國(guó)械備20170669號(hào)Stryker   Medical3665   Midlink Drive, Kalamazoo, MI 490482022-09-01 變更
232手動(dòng)攝影平床國(guó)械備20170400號(hào)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(guó)械備20191434號(hào)//2022-09-01 變更
234正畸鉗國(guó)械備20160817號(hào)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
235牙科輸送頭國(guó)械備20200401號(hào)3M   Deutschland GmbHOhmstra?e   3, 86899 Landsberg, GERMANY2022-09-01 變更
236牙科輸送頭國(guó)械備20200404號(hào)3M   Deutschland GmbHRütistrasse   7, CH-9469 Haag2022-09-01 變更
237CD79b檢測(cè)試劑國(guó)械備20220385號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
238CD14檢測(cè)試劑國(guó)械備20220384號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
239CD45RA檢測(cè)試劑國(guó)械備20220383號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
240CD7檢測(cè)試劑國(guó)械備20220382號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
241CD127檢測(cè)試劑國(guó)械備20220381號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
242CD11b檢測(cè)試劑國(guó)械備20220380號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-09-01 有效
243血管鉗國(guó)械備20160732號(hào)SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-01 變更
244手術(shù)剪 國(guó)械備20150597號(hào)SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-01 變更
245持針器國(guó)械備20150598號(hào)SCANLAN   INTERNATIONAL, INC.ONE   SCANLAN PLAZA Saint Paul, MN USA 551072022-09-01 變更
246肉湯培養(yǎng)基   MH BROTH with 3% LHB國(guó)械備20150486號(hào)Beckman   Coulter, Inc.1105   North Main Street, Lombard, Illiois 60148, USA2022-09-01 變更

進(jìn)口第一類(lèi)醫(yī)療器械備案產(chǎn)品備案數(shù)據(jù)，一方面說(shuō)明第一類(lèi)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(duì)我國(guó)龐大的醫(yī)療器械消費(fèi)市場(chǎng)的青睞。


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