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2024年1月國家局批準進口第一類醫(yī)療器械產(chǎn)品備案125項
發(fā)布日期:2024-02-18 18:16瀏覽次數(shù):903次
從我的認識來看，一類醫(yī)療器械備案產(chǎn)品在臨床上扮演了重要且廣泛的角色，在臨床應(yīng)用上幫助到許多患者和臨床工作者們，因此，我是幾乎每月都會為大家介紹國家藥監(jiān)局批準的進口第一類醫(yī)療器械產(chǎn)品備案事項，一起來看2024年1月有哪些進口第一類醫(yī)療器械產(chǎn)品。

從我的認識來看，一類醫(yī)療器械備案產(chǎn)品在臨床上扮演了重要且廣泛的角色，在臨床應(yīng)用上幫助到許多患者和臨床工作者們，因此，我是幾乎每月都會為大家介紹國家藥監(jiān)局批準的進口第一類醫(yī)療器械產(chǎn)品備案事項，一起來看2024年1月有哪些進口第一類醫(yī)療器械產(chǎn)品。

進口第一類醫(yī)療器械產(chǎn)品備案.jpg

2024年1月國家局批準進口第一類醫(yī)療器械產(chǎn)品備案125項

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醫(yī)用檢查手套國械備20161386號Ansell   Healthcare Europe NVLot   6129, Jalan Haji Abdul Manan, Batu 5 1/4, Off Jalan Meru 41050 Klang,   Malaysia2024-01-31 變更
2緩沖液國械備20160496號Siemens   Healthcare Diagnostics Products GmbHEmil-von-Behring-Str.   76, 35041 Marburg, Germany2024-01-31 無效
3軟軸牽開器國械備20161616號pro   med instruments GmbHBoetzinger   Strasse 38 79111 Freiburg Germany2024-01-31 變更
4手術(shù)用頭架國械備20161617號pro   med instruments GmbHWaldmatten   6 79224 Umkirch Germany2024-01-31 變更
5脊柱手術(shù)器械包國械備20171186號冠亞生技股份有限公司 新北市新店區(qū)復(fù)興里復(fù)興路43號（1樓）2024-01-31 變更
6放射治療患者用定位裝置國械備20240042號Qfix440   Church Road Avondale Pennsylvania 19311 USA2024-01-31 有效
7手術(shù)輔助移動式手術(shù)照明燈國械備20230017號Vivo   Surgical Private Limited67   Ayer Rajah Crescent #01-01/02 Singapore 1399502024-01-30 變更
8血管鉗國械備20240041號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
9腰椎固定器國械備20151241號Aspen   Medical Products,Inc.6481   Oak Canyon Irvine,CA 926182024-01-30 變更
10胸腰骶固定器國械備20151193號Aspen   Medical Products,Inc.6481   Oak Canyon Irvine,CA 926182024-01-30 變更
11手術(shù)剪國械備20240040號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
12手術(shù)刀國械備20240039號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
13器械鉗國械備20240038號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
14牽開器國械備20240037號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
15醫(yī)用鑷國械備20240036號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
16剝離器國械備20240035號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
17持釘器國械備20240034號MCTBIO46,   Chobu-ro, Mohyeon-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Korea Rep.2024-01-29 有效
18冷凍包埋劑國械備20240033號SAKURA   FINETEK U.S.A., INC.1750   W 214th St TORRANCE, CA USA 905012024-01-29 有效
19全自動免疫檢驗系統(tǒng)用底物液國械備20150154號Siemens   Healthcare Diagnostics Inc.500   GBC Drive, Mailstop 514 P.O.Box 6101 Newark, DE 19714 United States2024-01-29 無效
20全自動免疫檢驗系統(tǒng)用底物液國械備20150161號Siemens   Healthcare Diagnostics Inc.500   GBC Drive, Mailstop 514 P.O.Box 6101 Newark, DE 19714 United States2024-01-29 無效
21牙科用鑷國械備20230193號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-29 變更
22口內(nèi)塑形刀國械備20230194號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-29 變更
23種植體安裝輔助器械國械備20181502號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
24牙科種植掃描定位件國械備20181322號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
25種植體安裝輔助器械國械備20181501號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
26牙科塑料基底國械備20181324號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
27牙科種植器械限深套國械備20200124號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
28扭力扳手國械備20170185號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
29種植輔助材料國械備20181132號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
30種植輔助器械國械備20170978號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
31轉(zhuǎn)移帽國械備20170216號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
32螺絲起國械備20150871號???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-01-29 變更
33試戴體國械備20200271號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE 2024-01-29 變更
34種植手術(shù)工具包國械備20181582號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
35牙用刀國械備20170979號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
36牙科手術(shù)通用器械包國械備20180323號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
37牙科種植手術(shù)工具包國械備20171180號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
38牙用尺國械備20171039號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
39血型及配血離心孵育工作組國械備20140148號Ortho-Clinical   Diagnostics2400   Millbrook Drive, Buffalo Grove, IL 60089, USA2024-01-29 變更
40固定用彈力束帶國械備20181484號Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2024-01-26 變更
41眼科手術(shù)器械國械備20240032號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
42眼科淚囊手術(shù)器械國械備20240031號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
43眼用咬除器國械備20240030號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
44髖關(guān)節(jié)手術(shù)支撐牽引架國械備20230388號ConMed   Corporation452   Randolph Street, Abington, MA 02351 United States2024-01-26 變更
45射頻治療儀用耦合劑國械備20240029號Solta   Medical, Inc.286   Eldridge Road Fairfield New Jersey 07004 USA2024-01-26 有效
46膝關(guān)節(jié)固定器國械備20240028號豐利國際股份有限公司南投縣南投市福興里永興路13號2、3樓2024-01-26 有效
47防漏膏國械備20190264號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2024-01-25 變更
48造口袋國械備20190930號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic; Priemyselny Park 3 07101 Michalovce   Slovakia.2024-01-25 變更
49造口袋國械備20190171號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2024-01-25 變更
50造口袋國械備20190594號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic; Priemyselny Park 3 07101 Michalovce   Slovakia.2024-01-25 變更
51造口底盤國械備20181394號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2024-01-25 變更
52造口袋國械備20140062號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic.2024-01-25 變更
53造口袋國械備20181323號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2024-01-25 變更
54造口袋國械備20190626號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic; Priemyselny Park 3 07101 Michalovce   Slovakia.2024-01-25 變更
55造口袋國械備20240027號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.    Priemyselny Park 3 07101 Michalovce Slovakia2024-01-25 有效
56骨科鉆頭國械備20240026號ConMed   Corporation11311   Concept Boulevard LARGO, FL USA 337732024-01-25 有效
57鉆針引導(dǎo)器國械備20160301號Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA; Dimbov?gen 2 SE-691 51   Karlskoga Sweden; Engvej 33, 3330 G?rl?se, Denmark2024-01-25 變更
58牙用尺國械備20152150號Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California   92887 USA2024-01-25 變更
59基礎(chǔ)外科手術(shù)器械國械備20240025號First   Class TradersOpposite   Oxford High School Kingra Road Langeraiali Sialkot - Pakistan2024-01-25 有效
60基礎(chǔ)外科手術(shù)器械國械備20240024號Brotra   International117   Ghazi Defence, Officer Colony, Sialkot - 51310, Pakistan2024-01-25 有效
61替代體國械備20181194號OSSTEM   IMPLANT Co., Ltd. 66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-01-25 變更
62一次性使用樣本收集器國械備20240023號HemoCue   ABKuvettgatan   1, SE-26271 Angelholm, Sweden2024-01-25 有效
63口腔觀察儀國械備20160921號SOPROAvenue   des Genévriers, ZAC Athélia IV, 13705 LA CIOTAT2024-01-24 變更
64牙科刮治器國械備20191351號Prodont-holliger   société par actions simplifiéeLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2024-01-24 變更
65口腔觀察儀國械備20160146號SOPROZAC   Athelia IV, Avenue des Genevriers, 13705 LA CIOTAT CEDEX FRANCE2024-01-24 變更
66耳鉗國械備20240022號FRIEDEN   MEDICAL INSTRUMENTS Mughal   Pura，Gohad Pur, 51310，Sialkot-Pakistan2024-01-23 有效
67刮治器國械備20151442號Hu-Friedy   Mfg.Co.,LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2024-01-23 變更
68脊柱用手術(shù)工具國械備20230172號Medtronic   Sofamor Danek USA, Inc.8347   N Steven Road, Milwaukee WI 53223, USA2024-01-23 變更
69造口袋國械備20190949號Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary2024-01-23 變更
70造口袋國械備20190945號Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary2024-01-23 變更
71膝關(guān)節(jié)手術(shù)工具國械備20210189號DePuy   Ireland UC請見附件“生產(chǎn)地址”。2024-01-22 變更
72種植體手術(shù)輔助工具國械備20240021號BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
73螺絲起國械備20240020號BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
74替代體國械備20240019號Biotem   Co., Ltd.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
75醫(yī)用檢查手套國械備20191018號Hartalega   NGC Sdn. Bhd.No.   1, Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor   Darul Ehsan MALAYSIA2024-01-22 變更
76檢查手套國械備20151767號Hartalega   NGC Sdn. Bhd.No.   1, Persiaran Tanjung, Kawasan Perindustrian Tanjung, 43900 Sepang, Selangor   Darul Ehsan Malaysia2024-01-22 變更
77彈力繃帶國械備20240018號LUROPAS   del Dott. Molinari & C. S.r.l.Via   Antonio Vivaldi, 4 - 24040 Calvenzano (BG) - Italy2024-01-22 有效
78關(guān)節(jié)假體試模    國械備20240017號Zimmer   Inc.1800   W. Center Street, Warsaw, Indiana 46580, USA2024-01-19 有效
79替代體國械備20181320號MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu2024-01-19 變更
80牙周探針國械備20230182號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 變更
81銀汞合金充填器國械備20230180號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 變更
82牙用充填器國械備20230181號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 變更
83牙科模型材料國械備20240016號BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutschland2024-01-18 有效
84口鏡國械備20190571號PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéELieu-dit   La Marnasse 63880 Olliergues France2024-01-18 變更
85牙探針國械備20190542號PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéELieu-dit   La Marnasse 63880 Olliergues France2024-01-18 變更
86牙科骨擠壓器國械備20190570號PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéE Lieu-dit La Marnasse 63880 Olliergues   France 2024-01-18 變更
87牙科刮治器國械備20200145號PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIééLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2024-01-17 變更
88牙科刮治器國械備20210597號PRODONT-HOLLIGER   SOCIETE PAR ACTIONSLieu-dit   La Marnasse,63880 OLLIERGUES,France2024-01-17 變更
89種植體螺絲起國械備20151826號Nobel   Biocare AB Dimbov?gen   2 SE-691 51 Karlskoga Sweden；  22715   Savi Ranch Parkway Yorba Linda California 92887 USA；Engvej 33, 3330 G?rl?se,   Denmark；74950 SCIONZIER France2024-01-17 變更
90擔架國械備20190694號MEDIROL   s.r.o.Dolní   Dubňany 58, 671 73 Tule?ice2024-01-17 變更
91清洗液國械備20180471號Siemens   Healthcare Diagnostics Inc.Emil-von-Behring-Str.76,   35041 Marburg, Germany2024-01-17 無效
92疝脫支撐器國械備20140070號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2024-01-16 變更
93牙科吸潮紙尖國械備20240015號（?）?????????   ??? ??? ??? ????4? 162024-01-15 有效
94基礎(chǔ)外科手術(shù)器械國械備20240014號ARTIFIED   INTERNATIONALMUGHAL   PURA MAIN STREET, AIRPORT ROAD,SIALKOT-51310, PAKISTAN2024-01-12 有效
95轉(zhuǎn)移體國械備20200349號Institut   Straumann AGPeter   Merian-Weg 12, 4002 Basel, Switzerland；Les Champs du Clos 2, 2613 Villeret,   Switzerland; Grand Rue 53 a,2606 Corgémont,Switzerland; 60 Minuteman Road,   Andover MA 01810, USA2024-01-12 變更
96替代體國械備20181463號Institut   Straumann AGPeter   Merian-Weg 12，4002 Basel，SWITZERLAND；Les Champs du Clos 2，2613   Villeret，SWITZERLAND；60 Minuteman Road，Andover，MA，01810，USA.2024-01-12 變更
97口腔科手術(shù)器械國械備20240013號ARTIFIED   INTERNATIONALMUGHAL   PURA MAIN STREET, AIRPORT ROAD,SIALKOT-51310, PAKISTAN2024-01-12 有效
98種植體螺絲起國械備20191350號GNI   co., ltd5F   501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, 18469, Rep.   of KOREA2024-01-12 變更
99放射治療托架國械備20240012號Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2024-01-11 有效
100醫(yī)用檢查手套國械備20240011號Henry   Schein Inc.110   Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230, THAILAND2024-01-11 有效
101造口袋國械備20210159號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2024-01-11 變更
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