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2025年6月国家局批准105项进口第一类医疗器械产品备案
发布日期:2025-08-09 00:00浏览次数:119次
来自国家药监局2025年8月8日公开披露的消息，2025年6月国家药监局批准进口第一类医疗器械产品备案事项105项，其中包括lpha-1-Fetoprotein抗体试剂（免疫组织化学）、Hepatocyte抗体试剂（免疫组织化学）、喷剂敷料、液体伤口敷料、乳头皲裂伤口护理软膏包、妊娠纹伤口护理软膏包等众多进口第一类医疗器械产品，一起来看具体内容。

来自国家药监局2025年8月8日公开披露的消息，2025年6月国家药监局批准进口第一类医疗器械产品备案事项105项，其中包括lpha-1-Fetoprotein抗体试剂（免疫组织化学）、Hepatocyte抗体试剂（免疫组织化学）、喷剂敷料、液体伤口敷料、乳头皲裂伤口护理软膏包、妊娠纹伤口护理软膏包等众多进口第一类医疗器械产品，一起来看具体内容。

进口第一类医疗器械产品备案.jpg

2025年6月进口第一类医疗器械产品备案信息

序号医疗器械产品名称医疗器械备案号备案人名称原文生产地址原文备案日期
1Alpha-1-Fetoprotein抗体试剂（免疫组织化学）国械备20190480号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2025-06-30 
2Hepatocyte抗体试剂（免疫组织化学）国械备20180371号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2025-06-30 
3喷剂敷料国械备20200222号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
4喷剂敷料国械备20200239号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
5液体伤口敷料国械备20200165号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
6液体伤口敷料国械备20210104号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
7液体伤口敷料国械备20210114号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
8乳头皲裂伤口护理软膏包国械备20191217号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
9妊娠纹伤口护理软膏包国械备20200117号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
10痱子伤口护理软膏国械备20191324号 LABORATOIRES FANNAMEX 68 Rue du Faubourg Saint Honoré 75008 PARIS   FRANCE2025-06-30 
11泪道探针国械备20250189号 MORIA S. A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-30 
12基础外科手术器械国械备20250188号Beauty   Teck International (Pvt)LtdHead   Marala Road, Machi Khokar, Sialkot 51310,Pakistan2025-06-27 
13DAB显色增强液国械备20250187号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2025-06-27 
14免疫显色试剂国械备20250186号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2025-06-27 
15CD79a抗体试剂国械备20250185号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2025-06-27 
16造口袋国械备20190594号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造口袋国械备20210168号ConvaTec   LimitedCarretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2025-06-27 
18肩关节手术工具国械备20151656号DePuy(Ireland)Loughbeg,   Ringaskiddy, Co.Cork, Ireland2025-06-27 
19种植辅助材料国械备20190760号MEDENTiKA   GmbHHammweg   8-10 76549 Hügelsheim Germany2025-06-27 
20种植体扫描体国械备20190664号MEDENTiKA   GmbHHammweg   8-10 76549 Hügelsheim Germany2025-06-27 
21吸引头国械备20161923号Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-27 
22牙科种植手术器械包国械备20250184号Dentium   Co., Ltd.76(3F,4F(Part),6F),   Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic   of Korea2025-06-26 
23显微眼用泪道扩张器国械备20250183号MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
24牙科工具包国械备20220480号TALLADIUM   ESPA?A, S.L.C/   Virginia Woolf, 17 - 25005 LLEIDA, Spain2025-06-25 
25眼用测量器国械备20250182号MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
26前房注入器国械备20250181号MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-25 
27牙科开口器国械备20210094号Ultradent   Products, Inc.505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2025-06-25 
28眼用剪国械备20250180号 MORIA S.A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
29显微眼用持针钳国械备20250179号MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-25 
30口腔科手术器械国械备20240280号Secure   Dental CompanyNear   New Ghalla Mandi, Main Aiman Abad Road, Sialkot-51310-Pakistan2025-06-25 
31显微眼用剪国械备20250178号 MORIA S.A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-25 
32开睑器国械备20250177号 MORIA S.A 27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-25 
33二件式造口袋国械备20190784号Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2025-06-24 
34造口护理用品附件国械备20191252号Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2025-06-24 
35造口栓国械备20181572号Coloplast   A/SColoplast   Hungary KFT, Coloplast utca 2, 4300 Nyírbátor, Hungary2025-06-24 
36手术辅助照明灯国械备20250176号DENTIS   CO.,LTD.6,   Yuram-ro, Dong-gu, Daegu 41065 South Korca2025-06-24 
37全自动样本处理系统国械备20250175号SEBIAParc   Technologique Léonard de Vinci, CP 8010 Lisses- 91008 EVRY CEDEX FRANCE2025-06-24 
38医用外固定支具国械备20171160号DJO,LLCCarretera   Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico   222442025-06-23 
39金胺O染色液国械备20250174号Dagatronics   Corporation 117,   Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do,10233，Korea2025-06-23 
40抗酸染色液国械备20250173号Dagatronics   Corporation 117,   Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 10233, Korea2025-06-23 
41革兰染色液国械备20250172号Dagatronics   Corporation 117,   Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 10233, Korea2025-06-23 
42苏木素染色液国械备20250171号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
43过碘酸雪夫染色液（糖原染色液，PAS） 国械备20250170号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
44亮绿－过碘酸雪夫氏染色液国械备20250169号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
45阿利辛蓝染色液国械备20250168号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-06-20 
46Tyrosinase抗体试剂（免疫组织化学）国械备20180628号Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2025-06-20 
47EMA抗体试剂（免疫组织化学）国械备20180447号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2025-06-20 
48代型材料国械备20160324号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口腔开口器国械备20160658号Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-20 
50牙用尺国械备20160190号Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-20 
51眼用刮匙国械备20250167号MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE2025-06-19 
52显微眼用镊国械备20250166号MORIA   S.A27   rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE 2025-06-19 
53牙科抛光条国械备20250165号DS   DENTASONIC SAVia   Piodella 12,CH-6933 Muzzano2025-06-19 
54牙科工具国械备20250003号TruAbutment   Korea Co., Ltd.104-214~216,   101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do,14449, Rep. of   Korea2025-06-19 
55牙科工具包国械备20250002号TruAbutment   Korea Co., Ltd.104-214~216,   101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do,14449, Rep. of   Korea2025-06-19 
56医用检查手套国械备20250164号Supermax   Glove Manufacturing Sdn. Bhd.Lot   42, Putra Industrial Park, Bukit Rahman Putra, 40160 Sungai Buloh, Selangor   Darul Ehsan, Malaysia2025-06-19 
57检查手套国械备20190584号Mexpo   International Inc.Lot   5091,Jalan Teratai, Batu 5, Off Jalan Meru,41050 Klang,Selangor Darul Ehsan,   Malaysia2025-06-17 
58造口底盘国械备20181394号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骨科手术器械国械备20250163号HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-06-13 
60基础外科手术器械国械备20250162号HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-06-13 
61乳腺加压弹力绷带国械备20170004号Amoena   Medizin-Orthop?die-Technik GmbHKapellenweg   36  83064 Raubling Germany2025-06-13 
62成形片国械备20210215号Ultradent   Products, Inc. 505   West Ultradent Drive (10200 South) ,South Jordan, Utah 84095, USA2025-06-13 
63腰部固定器国械备20250161号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany2025-06-12 
64膝关节固定器国械备20250160号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany2025-06-12 
65膝部固定器国械备20250159号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany2025-06-12 
66牙骨锤国械备20161789号Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-11 
67牙用手术刀国械备20161103号Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-11 
68脊柱牵开器国械备20190782号Starmed   Engineering (Pvt) Ltd.191,   Khadim Ali Road, Sialkot-Pakistan2025-06-10 
69脊柱用手术工具国械备20161250号Medtronic   Sofamor Danek USA, Inc.Werftstr.   17, 94469 Deggendorf, Germany；4340 Swinnea Road, Memphis, TN 38118, USA2025-06-09 
70引流袋国械备20150058号怡安醫療器材股份有限公司苗栗县竹南镇新南里7邻三角店二十八之二号2025-06-09 
71造口袋国械备20240027号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造口袋国械备20210169号ConvaTec   LimitedCarretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2025-06-09 
73造口袋国械备20190171号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造口袋国械备20181323号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试剂国械备20160251号Roche   Molecular Systems, Inc.1080   US Highway 202 South, Branchburg, NJ 08876, USA2025-06-09 
76带固定板的颈椎融合器手术工具国械备20170867号Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2025-06-06 
77 冷冻切片机  国械备20161064号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-06-06 
78冷冻切片机 国械备20180127号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2025-06-06 
79冷冻切片机国械备20161066号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-06-06 
80基础外科手术器械国械备20250158号Surtex   Instruments Ltd.Kingspark   Business Centre, Unit 202, 152-178 Kingston Road, New Malden, KT3 3ST Great   Britain.2025-06-06 
81医用检查手套国械备20250157号Hartalega   NGc Sdn. Bhd.No.1,   Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor Darul   Ehsan MALAYSIA2025-06-05 
82超声探头穿刺架国械备20250037号ELESTA   S.P.A.Via   Arsiero Salvanti, 41/43-50041 Calenzano (FI) - Italy2025-06-05 
83核酸提取或纯化试剂国械备20170757号台灣圓點奈米技術股份有限公司桃園縣桃園市龍山里龍壽街81巷12弄2號2025-06-05 
84核酸提取试剂国械备20210579号台灣圓點奈米技術股份有限公司桃園市桃園區龍山里龍壽街   81 巷 12 弄 2 號2025-06-05 
85核酸提取试剂国械备20210577号台灣圓點奈米技術股份有限公司桃園市桃園區龍山里龍壽街   81 巷 12 弄 2 號2025-06-05 
86全自动核酸提取仪国械备20151812号台灣圓點奈米技術股份有限公司台灣桃園市桃園區龍山里龍壽街81巷12弄2號2025-06-05 
87口镜国械备20250156号賈雷格斯實業有限公司台中市潭子區豐栗路100巷88弄8號2025-06-05 
88牙用输送器国械备20161102号Hu-Friedy   Mfg. Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-04 
89唇颊牵开器国械备20160659号Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States2025-06-04 
90腰椎融合器手术工具国械备20170101号Bricon   GmbHWasserkuppenstrasse   29-31 - 36043 Fulda Germany2025-06-03 
91椎板固定板系统手术工具国械备20220080号Bricon   GmbHEisenbahnstrasse   100 78573 Wurmlingen Germany2025-06-03 
92颈椎前路固定板系统手术工具国械备20170832号Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2025-06-03 
93脊柱后路内固定系统手术工具国械备20170833号bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2025-06-03 
94咬骨钳国械备20171018号bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2025-06-03 
95脊柱后路内固定系统手术工具国械备20190313号Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2025-06-03 
96持瓣器国械备20240185号Edwards   Lifesciences LLCOne   Edwards Way Irvine, CA USA 926142025-06-03 
97医用转移板国械备20250155号MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, GERMANY2025-06-03 
98手术头架国械备20250154号MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, GERMANY2025-06-03 
99膝关节支撑架国械备20250153号MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, GERMANY2025-06-03 
100医用支撑腿架国械备20250152号MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, GERMANY2025-06-03 
101托手架国械备20250151号MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, GERMANY2025-06-03 
102血细胞分析仪用溶血剂国械备20160699号BOULE   MEDICAL AB Domnarvsgatan   4, SE-163 53 Spanga, Sweden2025-06-03 
103血细胞分析仪用溶血剂国械备20151347号BOULE   MEDICAL AB Domnarvsgatan   4, SE-163 53 Spanga, Sweden2025-06-03 
104血细胞分析仪用稀释液国械备20160700号BOULE   MEDICAL AB Domnarvsgatan   4, SE-163 53 Spanga, Sweden2025-06-03 
105血细胞分析用稀释液国械备20151346号Boule   Medical ABDomnarvsgatan   4, SE-163 53 Sp?nga, Sweden 2025-06-03 

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