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2024年1月國(guó)家局批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案125項(xiàng)
發(fā)布日期:2024-02-18 18:16瀏覽次數(shù):698次
從我的認(rèn)識(shí)來(lái)看，一類(lèi)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(huì)為大家介紹國(guó)家藥監(jiān)局批準(zhǔn)的進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案事項(xiàng)，一起來(lái)看2024年1月有哪些進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品。

從我的認(rèn)識(shí)來(lái)看，一類(lèi)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(huì)為大家介紹國(guó)家藥監(jiān)局批準(zhǔn)的進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案事項(xiàng)，一起來(lái)看2024年1月有哪些進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品。

進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案.jpg

2024年1月國(guó)家局批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案125項(xiàng)

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醫(yī)用檢查手套國(guó)械備20161386號(hào)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(guó)械備20160496號(hào)Siemens   Healthcare Diagnostics Products GmbHEmil-von-Behring-Str.   76, 35041 Marburg, Germany2024-01-31 無(wú)效
3軟軸牽開(kāi)器國(guó)械備20161616號(hào)pro   med instruments GmbHBoetzinger   Strasse 38 79111 Freiburg Germany2024-01-31 變更
4手術(shù)用頭架國(guó)械備20161617號(hào)pro   med instruments GmbHWaldmatten   6 79224 Umkirch Germany2024-01-31 變更
5脊柱手術(shù)器械包國(guó)械備20171186號(hào)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(hào)（1樓）2024-01-31 變更
6放射治療患者用定位裝置國(guó)械備20240042號(hào)Qfix440   Church Road Avondale Pennsylvania 19311 USA2024-01-31 有效
7手術(shù)輔助移動(dòng)式手術(shù)照明燈國(guó)械備20230017號(hào)Vivo   Surgical Private Limited67   Ayer Rajah Crescent #01-01/02 Singapore 1399502024-01-30 變更
8血管鉗國(guó)械備20240041號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
9腰椎固定器國(guó)械備20151241號(hào)Aspen   Medical Products,Inc.6481   Oak Canyon Irvine,CA 926182024-01-30 變更
10胸腰骶固定器國(guó)械備20151193號(hào)Aspen   Medical Products,Inc.6481   Oak Canyon Irvine,CA 926182024-01-30 變更
11手術(shù)剪國(guó)械備20240040號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
12手術(shù)刀國(guó)械備20240039號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
13器械鉗國(guó)械備20240038號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
14牽開(kāi)器國(guó)械備20240037號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
15醫(yī)用鑷國(guó)械備20240036號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
16剝離器國(guó)械備20240035號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
17持釘器國(guó)械備20240034號(hào)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(guó)械備20240033號(hào)SAKURA   FINETEK U.S.A., INC.1750   W 214th St TORRANCE, CA USA 905012024-01-29 有效
19全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液國(guó)械備20150154號(hào)Siemens   Healthcare Diagnostics Inc.500   GBC Drive, Mailstop 514 P.O.Box 6101 Newark, DE 19714 United States2024-01-29 無(wú)效
20全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液國(guó)械備20150161號(hào)Siemens   Healthcare Diagnostics Inc.500   GBC Drive, Mailstop 514 P.O.Box 6101 Newark, DE 19714 United States2024-01-29 無(wú)效
21牙科用鑷國(guó)械備20230193號(hào)PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-29 變更
22口內(nèi)塑形刀國(guó)械備20230194號(hào)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(guó)械備20181502號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
24牙科種植掃描定位件國(guó)械備20181322號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
25種植體安裝輔助器械國(guó)械備20181501號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
26牙科塑料基底國(guó)械備20181324號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
27牙科種植器械限深套國(guó)械備20200124號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
28扭力扳手國(guó)械備20170185號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
29種植輔助材料國(guó)械備20181132號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
30種植輔助器械國(guó)械備20170978號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
31轉(zhuǎn)移帽國(guó)械備20170216號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
32螺絲起國(guó)械備20150871號(hào)???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-01-29 變更
33試戴體國(guó)械備20200271號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE 2024-01-29 變更
34種植手術(shù)工具包國(guó)械備20181582號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
35牙用刀國(guó)械備20170979號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
36牙科手術(shù)通用器械包國(guó)械備20180323號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
37牙科種植手術(shù)工具包國(guó)械備20171180號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 變更
38牙用尺國(guó)械備20171039號(hào)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(guó)械備20140148號(hào)Ortho-Clinical   Diagnostics2400   Millbrook Drive, Buffalo Grove, IL 60089, USA2024-01-29 變更
40固定用彈力束帶國(guó)械備20181484號(hào)Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2024-01-26 變更
41眼科手術(shù)器械國(guó)械備20240032號(hào)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(guó)械備20240031號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
43眼用咬除器國(guó)械備20240030號(hào)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(guó)械備20230388號(hào)ConMed   Corporation452   Randolph Street, Abington, MA 02351 United States2024-01-26 變更
45射頻治療儀用耦合劑國(guó)械備20240029號(hào)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(guó)械備20240028號(hào)豐利國(guó)際股份有限公司南投縣南投市福興里永興路13號(hào)2、3樓2024-01-26 有效
47防漏膏國(guó)械備20190264號(hào)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(guó)械備20190930號(hào)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(guó)械備20190171號(hào)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(guó)械備20190594號(hào)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(pán)國(guó)械備20181394號(hào)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(guó)械備20140062號(hào)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(guó)械備20181323號(hào)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(guó)械備20190626號(hào)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(guó)械備20240027號(hào)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(guó)械備20240026號(hào)ConMed   Corporation11311   Concept Boulevard LARGO, FL USA 337732024-01-25 有效
57鉆針引導(dǎo)器國(guó)械備20160301號(hào)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(guó)械備20152150號(hào)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(guó)械備20240025號(hào)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(guó)械備20240024號(hào)Brotra   International117   Ghazi Defence, Officer Colony, Sialkot - 51310, Pakistan2024-01-25 有效
61替代體國(guó)械備20181194號(hào)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(guó)械備20240023號(hào)HemoCue   ABKuvettgatan   1, SE-26271 Angelholm, Sweden2024-01-25 有效
63口腔觀察儀國(guó)械備20160921號(hào)SOPROAvenue   des Genévriers, ZAC Athélia IV, 13705 LA CIOTAT2024-01-24 變更
64牙科刮治器國(guó)械備20191351號(hào)Prodont-holliger   société par actions simplifiéeLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2024-01-24 變更
65口腔觀察儀國(guó)械備20160146號(hào)SOPROZAC   Athelia IV, Avenue des Genevriers, 13705 LA CIOTAT CEDEX FRANCE2024-01-24 變更
66耳鉗國(guó)械備20240022號(hào)FRIEDEN   MEDICAL INSTRUMENTS Mughal   Pura，Gohad Pur, 51310，Sialkot-Pakistan2024-01-23 有效
67刮治器國(guó)械備20151442號(hào)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(guó)械備20230172號(hào)Medtronic   Sofamor Danek USA, Inc.8347   N Steven Road, Milwaukee WI 53223, USA2024-01-23 變更
69造口袋國(guó)械備20190949號(hào)Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary2024-01-23 變更
70造口袋國(guó)械備20190945號(hào)Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary2024-01-23 變更
71膝關(guān)節(jié)手術(shù)工具國(guó)械備20210189號(hào)DePuy   Ireland UC請(qǐng)見(jiàn)附件“生產(chǎn)地址”。2024-01-22 變更
72種植體手術(shù)輔助工具國(guó)械備20240021號(hào)BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
73螺絲起國(guó)械備20240020號(hào)BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
74替代體國(guó)械備20240019號(hào)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(guó)械備20191018號(hào)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(guó)械備20151767號(hào)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(guó)械備20240018號(hào)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(guó)械備20240017號(hào)Zimmer   Inc.1800   W. Center Street, Warsaw, Indiana 46580, USA2024-01-19 有效
79替代體國(guó)械備20181320號(hào)MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu2024-01-19 變更
80牙周探針國(guó)械備20230182號(hào)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(guó)械備20230180號(hào)PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 變更
82牙用充填器國(guó)械備20230181號(hào)PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 變更
83牙科模型材料國(guó)械備20240016號(hào)BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutschland2024-01-18 有效
84口鏡國(guó)械備20190571號(hào)PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéELieu-dit   La Marnasse 63880 Olliergues France2024-01-18 變更
85牙探針國(guó)械備20190542號(hào)PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéELieu-dit   La Marnasse 63880 Olliergues France2024-01-18 變更
86牙科骨擠壓器國(guó)械備20190570號(hào)PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéE Lieu-dit La Marnasse 63880 Olliergues   France 2024-01-18 變更
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