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2025年6月國(guó)家局批準(zhǔn)105項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
發(fā)布日期:2025-08-09 00:00瀏覽次數(shù):143次
來(lái)自國(guó)家藥監(jiān)局2025年8月8日公開(kāi)披露的消息，2025年6月國(guó)家藥監(jiān)局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)105項(xiàng)，其中包括lpha-1-Fetoprotein抗體試劑（免疫組織化學(xué)）、Hepatocyte抗體試劑（免疫組織化學(xué)）、噴劑敷料、液體傷口敷料、乳頭皸裂傷口護(hù)理軟膏包、妊娠紋傷口護(hù)理軟膏包等眾多進(jìn)口第一類醫(yī)療器械產(chǎn)品，一起來(lái)看具體內(nèi)容。

來(lái)自國(guó)家藥監(jiān)局2025年8月8日公開(kāi)披露的消息，2025年6月國(guó)家藥監(jiān)局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)105項(xiàng)，其中包括lpha-1-Fetoprotein抗體試劑（免疫組織化學(xué)）、Hepatocyte抗體試劑（免疫組織化學(xué)）、噴劑敷料、液體傷口敷料、乳頭皸裂傷口護(hù)理軟膏包、妊娠紋傷口護(hù)理軟膏包等眾多進(jìn)口第一類醫(yī)療器械產(chǎn)品，一起來(lái)看具體內(nèi)容。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2025年6月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

序號(hào)醫(yī)療器械產(chǎn)品名稱醫(yī)療器械備案號(hào)備案人名稱原文生產(chǎn)地址原文備案日期
1Alpha-1-Fetoprotein抗體試劑（免疫組織化學(xué)）國(guó)械備20190480號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2025-06-30 
2Hepatocyte抗體試劑（免疫組織化學(xué)）國(guó)械備20180371號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2025-06-30 
3噴劑敷料國(guó)械備20200222號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
4噴劑敷料國(guó)械備20200239號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
5液體傷口敷料國(guó)械備20200165號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
6液體傷口敷料國(guó)械備20210104號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
7液體傷口敷料國(guó)械備20210114號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
8乳頭皸裂傷口護(hù)理軟膏包國(guó)械備20191217號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
9妊娠紋傷口護(hù)理軟膏包國(guó)械備20200117號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
10痱子傷口護(hù)理軟膏國(guó)械備20191324號(hào) LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
11淚道探針國(guó)械備20250189號(hào) MORIA S. A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-30 
12基礎(chǔ)外科手術(shù)器械國(guó)械備20250188號(hào)Beauty   Teck International (Pvt)LtdHead   Marala Road, Machi Khokar, Sialkot 51310,Pakistan2025-06-27 
13DAB顯色增強(qiáng)液國(guó)械備20250187號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2025-06-27 
14免疫顯色試劑國(guó)械備20250186號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2025-06-27 
15CD79a抗體試劑國(guó)械備20250185號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2025-06-27 
16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.2025-06-27 
17造口袋國(guó)械備20210168號(hào)ConvaTec   LimitedCarretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2025-06-27 
18肩關(guān)節(jié)手術(shù)工具國(guó)械備20151656號(hào)DePuy(Ireland)Loughbeg,   Ringaskiddy, Co.Cork, Ireland2025-06-27 
19種植輔助材料國(guó)械備20190760號(hào)MEDENTiKA   GmbHHammweg   8-10 76549 Hügelsheim Germany2025-06-27 
20種植體掃描體國(guó)械備20190664號(hào)MEDENTiKA   GmbHHammweg   8-10 76549 Hügelsheim Germany2025-06-27 
21吸引頭國(guó)械備20161923號(hào)Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-27 
22牙科種植手術(shù)器械包國(guó)械備20250184號(hào)Dentium   Co., Ltd.76(3F,4F(Part),6F),   Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic   of Korea2025-06-26 
23顯微眼用淚道擴(kuò)張器國(guó)械備20250183號(hào)MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
24牙科工具包國(guó)械備20220480號(hào)TALLADIUM   ESPA?A, S.L.C/   Virginia Woolf, 17 - 25005 LLEIDA, Spain2025-06-25 
25眼用測(cè)量器國(guó)械備20250182號(hào)MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
26前房注入器國(guó)械備20250181號(hào)MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-25 
27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, USA2025-06-25 
28眼用剪國(guó)械備20250180號(hào) MORIA S.A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
29顯微眼用持針鉗國(guó)械備20250179號(hào)MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-25 
30口腔科手術(shù)器械國(guó)械備20240280號(hào)Secure   Dental CompanyNear   New Ghalla Mandi, Main Aiman Abad Road, Sialkot-51310-Pakistan2025-06-25 
31顯微眼用剪國(guó)械備20250178號(hào) MORIA S.A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-25 
32開(kāi)瞼器國(guó)械備20250177號(hào) MORIA S.A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
33二件式造口袋國(guó)械備20190784號(hào)Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2025-06-24 
34造口護(hù)理用品附件國(guó)械備20191252號(hào)Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2025-06-24 
35造口栓國(guó)械備20181572號(hào)Coloplast   A/SColoplast   Hungary KFT, Coloplast utca 2, 4300 Nyírbátor, Hungary2025-06-24 
36手術(shù)輔助照明燈國(guó)械備20250176號(hào)DENTIS   CO.,LTD.6,   Yuram-ro, Dong-gu, Daegu 41065 South Korca2025-06-24 
37全自動(dòng)樣本處理系統(tǒng)國(guó)械備20250175號(hào)SEBIAParc   Technologique Léonard de Vinci, CP 8010 Lisses- 91008 EVRY CEDEX FRANCE2025-06-24 
38醫(yī)用外固定支具國(guó)械備20171160號(hào)DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442025-06-23 
39金胺O染色液國(guó)械備20250174號(hào)Dagatronics   Corporation 117,   Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do,10233，Korea2025-06-23 
40抗酸染色液國(guó)械備20250173號(hào)Dagatronics   Corporation 117,   Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 10233, Korea2025-06-23 
41革蘭染色液國(guó)械備20250172號(hào)Dagatronics   Corporation 117,   Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 10233, Korea2025-06-23 
42蘇木素染色液國(guó)械備20250171號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
43過(guò)碘酸雪夫染色液（糖原染色液，PAS） 國(guó)械備20250170號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
44亮綠－過(guò)碘酸雪夫氏染色液國(guó)械備20250169號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
45阿利辛藍(lán)染色液國(guó)械備20250168號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
46Tyrosinase抗體試劑（免疫組織化學(xué)）國(guó)械備20180628號(hào)Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2025-06-20 
47EMA抗體試劑（免疫組織化學(xué)）國(guó)械備20180447號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2025-06-20 
48代型材料國(guó)械備20160324號(hào)Osstem   Implant Co., Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002, Republic of Korea; 66-48,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002, Republic of Korea2025-06-20 
49口腔開(kāi)口器國(guó)械備20160658號(hào)Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-20 
50牙用尺國(guó)械備20160190號(hào)Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-20 
51眼用刮匙國(guó)械備20250167號(hào)MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-19 
52顯微眼用鑷國(guó)械備20250166號(hào)MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-19 
53牙科拋光條國(guó)械備20250165號(hào)DS   DENTASONIC SAVia   Piodella 12,CH-6933 Muzzano2025-06-19 
54牙科工具國(guó)械備20250003號(hào)TruAbutment   Korea Co., Ltd.104-214~216,   101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do,14449, Rep. of   Korea2025-06-19 
55牙科工具包國(guó)械備20250002號(hào)TruAbutment   Korea Co., Ltd.104-214~216,   101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do,14449, Rep. of   Korea2025-06-19 
56醫(yī)用檢查手套國(guó)械備20250164號(hào)Supermax   Glove Manufacturing Sdn. Bhd.Lot   42, Putra Industrial Park, Bukit Rahman Putra, 40160 Sungai Buloh, Selangor   Darul Ehsan, Malaysia2025-06-19 
57檢查手套國(guó)械備20190584號(hào)Mexpo   International Inc.Lot   5091,Jalan Teratai, Batu 5, Off Jalan Meru,41050 Klang,Selangor Darul Ehsan,   Malaysia2025-06-17 
58造口底盤國(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 Republic2025-06-16 
59骨科手術(shù)器械國(guó)械備20250163號(hào)HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-06-13 
60基礎(chǔ)外科手術(shù)器械國(guó)械備20250162號(hào)HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-06-13 
61乳腺加壓彈力繃帶國(guó)械備20170004號(hào)Amoena   Medizin-Orthop?die-Technik GmbHKapellenweg   36  83064 Raubling Germany2025-06-13 
62成形片國(guó)械備20210215號(hào)Ultradent   Products, Inc. 505   West Ultradent Drive (10200 South) ,South Jordan, Utah 84095, USA2025-06-13 
63腰部固定器國(guó)械備20250161號(hào)SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany2025-06-12 
64膝關(guān)節(jié)固定器國(guó)械備20250160號(hào)SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany2025-06-12 
65膝部固定器國(guó)械備20250159號(hào)SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany2025-06-12 
66牙骨錘國(guó)械備20161789號(hào)Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-11 
67牙用手術(shù)刀國(guó)械備20161103號(hào)Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-11 
68脊柱牽開(kāi)器國(guó)械備20190782號(hào)Starmed   Engineering (Pvt) Ltd.191,   Khadim Ali Road, Sialkot-Pakistan2025-06-10 
69脊柱用手術(shù)工具國(guó)械備20161250號(hào)Medtronic   Sofamor Danek USA, Inc.Werftstr.   17, 94469 Deggendorf, Germany；4340 Swinnea Road, Memphis, TN 38118, USA2025-06-09 
70引流袋國(guó)械備20150058號(hào)怡安醫(yī)療器材股份有限公司苗栗縣竹南鎮(zhèn)新南里7鄰三角店二十八之二號(hào)2025-06-09 
71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 Slovakia2025-06-09 
72造口袋國(guó)械備20210169號(hào)ConvaTec   LimitedCarretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2025-06-09 
73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.2025-06-09 
74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 Republic2025-06-09 
75核酸分析用病毒裂解試劑國(guó)械備20160251號(hào)Roche   Molecular Systems, Inc.1080   US Highway 202 South, Branchburg, NJ 08876, USA2025-06-09 
76帶固定板的頸椎融合器手術(shù)工具國(guó)械備20170867號(hào)Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2025-06-06 
77 冷凍切片機(jī)  國(guó)械備20161064號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-06-06 
78冷凍切片機(jī) 國(guó)械備20180127號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2025-06-06 
79冷凍切片機(jī)國(guó)械備20161066號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-06-06 
80基礎(chǔ)外科手術(shù)器械國(guó)械備20250158號(hào)Surtex   Instruments Ltd.Kingspark   Business Centre, Unit 202, 152-178 Kingston Road, New Malden, KT3 3ST Great   Britain.2025-06-06 
81醫(yī)用檢查手套國(guó)械備20250157號(hào)Hartalega   NGc Sdn. Bhd.No.1,   Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor Darul   Ehsan MALAYSIA2025-06-05 
82超聲探頭穿刺架國(guó)械備20250037號(hào)ELESTA   S.P.A.Via   Arsiero Salvanti, 41/43-50041 Calenzano (FI) - Italy2025-06-05 
83核酸提取或純化試劑國(guó)械備20170757號(hào)臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司桃園縣桃園市龍山里龍壽街81巷12弄2號(hào)2025-06-05 
84核酸提取試劑國(guó)械備20210579號(hào)臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司桃園市桃園區(qū)龍山里龍壽街   81 巷 12 弄 2 號(hào)2025-06-05 
85核酸提取試劑國(guó)械備20210577號(hào)臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司桃園市桃園區(qū)龍山里龍壽街   81 巷 12 弄 2 號(hào)2025-06-05 
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