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當(dāng)前位置：網(wǎng)站首頁>新聞動態(tài) >11月共計95個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案被批準(zhǔn)
11月共計95個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案被批準(zhǔn)
發(fā)布日期:2021-12-07 00:00瀏覽次數(shù):2241次
據(jù)藥監(jiān)總局近日發(fā)布的官方數(shù)據(jù)，2021年11月，共計95個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案或變更備案被批準(zhǔn)。

據(jù)藥監(jiān)總局近日發(fā)布的官方數(shù)據(jù)，2021年11月，共計95個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案或變更備案被批準(zhǔn)。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2021年11月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

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)
1CD56檢測試劑國械備20210566號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-30 有效
2CD45檢測試劑國械備20210565號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-30 有效
3CD11b檢測試劑國械備20210564號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-30 有效
4CD16檢測試劑國械備20210563號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-30 有效
5CD117檢測試劑國械備20210562號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-30 有效
6自動樣本處理及制片機(jī)國械備20210561號Hologic, Inc.445 Simarano Drive Marlborough, Massachusetts 01752 USA2021-11-30 有效
7測瓣器國械備20210560號Medtronic, Inc.1851 E. Deere Avenue Santa Ana, CA 92705 USA2021-11-29 有效
8打磨拋光清潔器具國械備20210559號SWISSDENTACARE SAVia della Posta,3  6934 Bioggio SWITZERLAND2021-11-29 有效
9造口袋國械備20190949號Coloplast A/SKerék utca 4, 2800 Tatabánya, Hungary2021-11-29 變更
10造口袋國械備20200704號Coloplast A/SColoplast Hungary KFT, Kerék utca 4, 2800 Tatabánya , Hungary2021-11-29 變更
11造口袋國械備20200543號Coloplast A/SBúzavirág út 15, 2800 Tatabánya, Hungary /Calle 58, Zona Franca La Lima, La Lima, Guadalupe, 30106 Cartago, Costa Rica2021-11-29 變更
12外科手術(shù)探針國械備20150874號pfm medical titanium gmbhHoefener Straβe 45 90431 Nuernberg Germany2021-11-26 變更
13子宮刮匙國械備20210558號KARL STORZ SE & Co. KGtake-off Gewerbepark 44-47, 78579 Neuhausen ob Eck, GERMANY2021-11-26 有效
14口角拉鉤國械備20170194號Kerr CorporationVia Strecce 4 P.O. 272 6934 Bioggio Switzerland2021-11-26 變更
15吸引管國械備20210557號Geister Medizintechnik GmbHFoehrenstr. 2, 78532 Tuttlingen, GERMANY2021-11-26 有效
16微生物樣本前處理系統(tǒng)國械備20181190號Copan WASP s.r.l.Via F. Perotti, 18, 25125 Brescia, Italy2021-11-26 變更
17全自動樣品處理系統(tǒng)國械備20191246號Copan Wasp S.r.l.Via F. Perotti, 18, 25125 Brescia, Italy2021-11-26 變更
18微生物樣本前處理系統(tǒng)國械備20190611號Copan WASP S.r.l.Via F. Perotti, 18, 25125 Brescia, Italy2021-11-26 變更
19血細(xì)胞分析用溶血劑國械備20210556號SEBIAParc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX  FRANCE2021-11-24 有效
20骨科用螺絲刀國械備20210555號愛派司生技股份有限公司新北市中和區(qū)橋和路120號2樓之22021-11-23 有效
21測瓣器及其組件國械備20152152號Corcym S.r.l.Via Crescentino, sn 13040 SALUGGIA (VC) ITALY2021-11-23 變更
22測瓣器及其組件國械備20152082號Corcym S.r.l.Via Crescentino, sn 13040 SALUGGIA (VC) ITALY2021-11-23 變更
23CD3抗體試劑（免疫組織化學(xué)）國械備20210554號Biocare Medical,LLC60 Berry Drive Pacheco,CA 945532021-11-23 有效
24生物顯微鏡國械備20210553號オリンパス株式會社長野県上伊那郡辰野町大字伊那富6666番地2021-11-23 有效
25生物顯微鏡國械備20210552號オリンパス株式會社長野県上伊那郡辰野町大字伊那富6666番地2021-11-23 有效
26血細(xì)胞分析用溶血劑國械備20151347號Boule Medical ABDomnarvsgatan 4, SE-163 53 Sp?nga, Sweden2021-11-23 變更
27生物顯微鏡國械備20210551號オリンパス株式會社長野県上伊那郡辰野町大字伊那富6666番地2021-11-23 有效
28血細(xì)胞分析用稀釋液國械備20151346號 Boule Medical AB Domnarvsgatan 4, SE-163 53 Sp?nga, Sweden 2021-11-23 變更
29血細(xì)胞分析用溶血劑國械備20160699號Boule Medical ABDomnarvsgatan 4, SE-163 53 Sp?nga, Sweden2021-11-23 變更
30生物顯微鏡國械備20210550號オリンパス株式會社長野県上伊那郡辰野町大字伊那富6666番地2021-11-23 有效
31血細(xì)胞分析用稀釋液國械備20160700號Boule Medical ABDomnarvsgatan 4, SE-163 53 Sp?nga, Sweden2021-11-23 變更
32 骨科手術(shù)器械國械備20210549號Berger Surgical Medical Products GmbHTake-off-Gewerbepark 4 - D-78579  Neuhausen ob Eck Germany2021-11-23 有效
33樣本稀釋液國械備20210548號東ソー株式會社日本國富山県富山市巖瀬古志町2番地2021-11-23 有效
34彈力繃帶國械備20161621號Urgo Healthcare Products Co., Ltd.154 Tiwanon Road,Moo 5, Tambol Bangkadee,Amphur Muang,Pathumthanee,12000,Thailand2021-11-23 變更
35注射器輔助推進(jìn)槍國械備20210547號Owen Mumford LimitedNo.19&21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC, 79200 Iskandar Puteri, Johor, MALAYSIA2021-11-23 有效
36IFN-γ檢測試劑國械備20210546號???? ????????? ??? ??? ??? ????? 700,?? 303?, 802? (???,????????)2021-11-22 有效
37牙用輸送器國械備20160919號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-11-22 變更
38包埋機(jī)冷臺國械備20210545號DIAPATH S.p.A.Via Savoldini, 71 - 24057 Martinengo (BG) - Italy2021-11-22 有效
39牙科種植用攜帶器國械備20210544號KJMEDITECH21, Cheomdanventure-ro 40beon-gil, Buk-gu, Gwangju, 61009, Rep. of KOREA2021-11-22 有效
40牙科手術(shù)器械國械備20210543號Nexton MFGDaska Road, Toor Abad, 51310 Sialkot - Pakistan2021-11-22 有效
41全自動毛細(xì)管電泳儀 20200049號Helena Biosciences EuropeSunderland Enterprise Park Colima Avenue Sunderland SR5 3XB United Kingdom2021-11-22 變更
42包埋機(jī)國械備20210542號DIAPATH S.p.A.Via Savoldini, 71 - 24057 Martinengo (BG) - Italy2021-11-22 有效
43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 Korea2021-11-18 有效
44MSH6抗體試劑（免疫組織化學(xué)）國械備20200236號Roche Diagnostics GmbH1910 East Innovation Park Drive, Tucson, AZ, 85755, United States2021-11-18 變更
45牙墊國械備20210540號MECTA Corporation19799 S.W.95th Avenue Tualatin OR 97062 USA2021-11-18 有效
46組織鑷國械備20210539號Berger Surgical Medical Products GmbHTake-off-Gewerbepark 4 D-78579 Neuhausen ob Eck Germany2021-11-18 有效
47外周血管隧道器及組件國械備20161093號Bard Peripheral Vascular, Inc.1625 West 3rd Street Tempe Arizona 85281 USA

2021-11-18 變更
48動靜脈通路隧道器及組件國械備20161092號Bard Peripheral Vascular, Inc.1625 West 3rd Street Tempe Arizona 85281 USA2021-11-18 變更
49醫(yī)用射線防護(hù)服國械備20210538號株式會社保科製作所茨城県牛久市神谷6-38-142021-11-17 有效
50蘇木素染色液國械備20150245號Ventana Medical Systems, Inc.1910E.Innovation Park Drive Tucson, AZ 85755 USA2021-11-17 變更
51蘇木素染色液 Hematoxylin國械備20150248號Ventana Medical Systems, Inc.1910E.Innovation Park Drive Tucson, AZ 85755 USA2021-11-17 變更
52頭顱放射治療定位裝置國械備20190535號MEDTEC, Inc.1401 8th St. SE, Orange City, IA, 51041, United States2021-11-17 變更
53核酸提取或純化試劑國械備20210537號QIAGEN GmbHQIAGEN Strasse 1, 40724 Hilden, Germany2021-11-16 有效
54核酸提取或純化試劑國械備20210536號QIAGEN GmbHQIAGEN Strasse 1, 40724 Hilden, Germany2021-11-16 有效
55研光器國械備20170108號DENTSPLY Caulk38W. Clarke Avenue Milford, DE, 19963, United States2021-11-15 變更
56一件式牙科種植體系統(tǒng)用配件國械備20161706號臺灣植體科技股份有限公司高科分公司高雄市路竹區(qū)路科二路63號5樓2021-11-15 變更
57牙科種植手術(shù)用工具包國械備20161708號臺灣植體科技股份有限公司高科分公司高雄市路竹區(qū)路科二路63號5樓2021-11-15 變更
58軟組織環(huán)切刀國械備20161260號臺灣植體科技股份有限公司高科分公司高雄市路竹區(qū)路科二路63號5樓2021-11-15 變更
59口腔科器械國械備20210535號LUCKYES DENTAL INSTRUMENTSSILVER STAR CHOWK,PREM NAGAR ROAD 51310 SIALKOT-PAKISTAN2021-11-12 有效
60革蘭染色液國械備20210534號RAL DIAGNOSTICSSite Montesquieu, 33650 MARTILLAC , FRANCE2021-11-12 有效
61牙用尺國械備20150781號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-11-12 變更
62牙科手術(shù)導(dǎo)板固定針 國械備20170786號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-11-12 變更
63螺絲起國械備20150871號???????(?)66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-11-12 變更
64上頜竇提升器國械備20151367號Osstem Implant Co., Ltd.66-16，Bansong-ro 513beon-gil，Haeundae-gu，Busan，Korea2021-11-12 變更
65正畸自鎖托槽開啟器國械備20210533號GNI Co., Ltd.5F 501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, Republic of Korea2021-11-12 有效
66研磨材料國械備20150186號株式會社松風(fēng)京都府京都市東山區(qū)福稻上高松町11番地2021-11-11 變更
67緩沖液國械備20210532號SEBIAParc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX  FRANCE2021-11-11 有效
68鋼板螺釘工具系統(tǒng)國械備20161364號Smith &Nephew, Inc.1，Alemannenstra?e 14 D-78532 Tuttlingen 78532 Germany;2，1450 Brooks Road Memphis, Tennessee 38116 USA；2021-11-11 變更
69膝關(guān)節(jié)手術(shù)器械國械備20151696號Smith & Nephew,Inc1450 Brooks Road Memphis Tennessee 38116 USA



2 Lengkok Teluk Kumbar 1 Jalan Teluk Kumbar

11920 Bayan Lepas, Penang  Malaysia



Zona Franca Metropolitana Building B3 and D2

Barreal de Heredia Costa Rica



No. 98 Kechuang Dong Liu Street

Beijing Economic-Technological  Development Area

Beijing 101111 China



Alemannenstraβe 14 D-78532 Tuttlingen

78532 Germany



Schachenallee 29, 5001 Aarau, SWITZERLAND

Dammweg 39, 5001 Aarau, SWITZERLAND

2021-11-11 變更
70醫(yī)用清洗機(jī)國械備20210531號ELMA Schmidbauer GmbHGottlieb-Daimler-Str.17 78224 Singen Germany2021-11-11 有效
71組織鉗國械備20160466號CM Instrumente GmbH  G?ns?cker 56，78532 Tuttlingen，Germany2021-11-10 變更
72CD38檢測試劑國械備20210530號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-10 有效
73CD38檢測試劑國械備20210529號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-10 有效
74CD38檢測試劑國械備20210528號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-10 有效
75CD38檢測試劑國械備20210527號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-10 有效
76CD25檢測試劑國械備20210526號BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-11-10 有效
77牙科輸送器20181644號Jinidental Co., LtdYi-dong, 147-15, Seonghyeon-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea（Seongseok-dong）2021-11-10 變更
78咬合紙20181638號Jinidental Co., Ltd.Yi-dong, 147-15, Seonghyeon-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea（Seongseok-dong）2021-11-10 變更
79革蘭染色液國械備20210525號RAL DIAGNOSTICSSite Montesquieu, 33650 MARTILLAC , FRANCE2021-11-10 有效
80鉆針深度停止器國械備20160920號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-11-10 變更
81射頻治療儀用凝膠國械備20210524號Solta Medical Inc.286 Eldridge Road Fairfield New Jersey 07004 USA2021-11-09 有效
82手術(shù)放大鏡國械備20191191號General Scientific Corporation77 Enterprise Dr., Ann Arbor, MI 481032021-11-09 變更
83旋入扳手國械備20151817號Ormco Corporation1332 South Lone Hill Avenue Glendora, California 91740, USA2021-11-09 變更
84導(dǎo)航手術(shù)工具國械備20190893號Medtronic Navigation, Inc.826 Coal Creek Circle Louisville, CO 80027 United States of America2021-11-08 變更
85比濁儀國械備20210523號Becton，Dickinson and Company100 Dayton Avenue, Ames, IA 50010, USA2021-11-08 有效
86醫(yī)用干式激光膠片國械備20210522號富士フイルム株式會社靜岡県富士宮市大中里200番地2021-11-08 有效
87全自動毛細(xì)管電泳儀國械備20210521號SEBIAParc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX  FRANCE2021-11-04 有效
88全自動樣品處理系統(tǒng)國械備20180054號Roche Diagnostics GmbHMaybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany2021-11-04 變更
89醫(yī)用離心機(jī)國械備20160135號Roche Diagnostics GmbHMaybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany2021-11-04 變更
90分類處理系統(tǒng)國械備20160289號Roche Diagnostics GmbHMaybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck, Germany2021-11-04 變更
91分杯處理系統(tǒng)國械備20160134號Roche Diagnostics GmbHMaybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany2021-11-04 變更
92生物顯微鏡國械備20210520號Leica Microsystems CMS GmbHErnst-Leitz-Stra?e 17-37,35578 Wetzlar, GERMANY2021-11-03 有效
93細(xì)胞計數(shù)板國械備20210519號東洋紡株式會社福井県敦賀市東洋町10番24號2021-11-03 有效
94牙挺國械備20151740號Hu-Friedy Mfg. Co., LLC3232 N. Rockwell Street, Chicago, IL 60618, United States2021-11-02 變更
95牙科成形片夾套裝國械備20170741號Garrison Dental Solutions LLC150 DeWitt Lane, Spring Lake, Michigan 49456 United States；16673 148th Ave, Unit 4, Spring Lake, Michigan 49456 United States2021-11-01 變更

從進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)這個維度，我們也能看到，不只是二類醫(yī)療器械、三類醫(yī)療器械，一類醫(yī)療器械同樣有許多值得大家關(guān)注的產(chǎn)品。要了解進(jìn)口第一類醫(yī)療器械產(chǎn)品備案流程或其它事項，歡迎您隨時方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司葉工聯(lián)系，電話：18058734169，微信同。

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