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2026年6月进口第一类医疗器械产品备案信息
发布日期:2026-07-08 00:00浏览次数:47次
来自国家药监局2026年7月8日公开披露的数据，2026年6月国家药监局批准了医用射线防护眼镜、螺丝起、全自动血沉分析仪、压力腿套、研光器、牙科种植导板定位螺丝、种植体扫描体等123个进口第一类医疗器械产品备案，更多内容见正文。

来自国家药监局2026年7月8日公开披露的数据，2026年6月国家药监局批准了医用射线防护眼镜、螺丝起、全自动血沉分析仪、压力腿套、研光器、牙科种植导板定位螺丝、种植体扫描体等123个进口第一类医疗器械产品备案，更多内容见正文。

进口第一类医疗器械产品备案.jpg

2026年6月进口第一类医疗器械产品备案信息

产品名称备案号备案人名称原文生产地址原文
医用射线防护眼镜国械备20260182号Dr.   Goos-Suprema GmbHBrechtelstrasse   29, 69126 Heidelberg, Germany
螺丝起国械备20260181号ARUM   DENTISTRY Co., Ltd.23,   Gukjegwahak 11-ro, Yuseong-gu, Daejeon, 34002, Korea
全自动血沉分析仪国械备20230264号ALIFAX   S.r.l.Via   Merano 30, 33045 Nimis(UD), ITALY 
全自动血沉分析仪国械备20210330号ALIFAX   S.r.l.Via   Merano 30 33045 Nimis (UD) Italy
全自动血沉分析仪国械备20220001号ALIFAX   S.r.l.Via   Merano 30, 33045 Nimis(UD), ITALY
全自动血沉分析仪国械备20230541号ALIFAX   S.r.l.Via   Merano 30 33045 Nimis (UD) Italy
压力腿套国械备20220554号Cardinal   Health 200，LLC Edificio   B20, Calle #2, Zona Franca Coyol, Alajuela, COSTA RICA;  Parque Industrial Itabo S.A., KM 18.5   Carretera Sanchez, Building 10, 10903 Haina, San Cristobal, DOMINICAN   REPUBLIC; 
牙科种植导板定位螺丝国械备20200316号Dentium   Co.,Ltd.B2F,   2F, 3F, 5F 76 Changnyong-daero 256beon-gil,Yeongtong-gu, Suwon-si,   Gyeonggi-do, Korea Rep.
骨锯国械备20161493号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
种植体扫描体国械备20161456号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
研光器国械备20161261号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
牙科手术器械包国械备20161520号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
口腔科手术器械包国械备20161291号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
种植用手术导板国械备20170535号Dentium   Co., Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea
钻针深度停止器国械备20161494号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
肩关节手术工具国械备20160185号DePuy   Orthopaedics, Inc.700   Orthopaedic Drive, Warsaw, Indiana 46582, USA
医用丝绸胶带国械备20151150号Solventum   Germany GmbHEdisonstraβe   6, 59157 Kamen, Germany
二氧化碳吸收剂国械备20161903号AirLife   Finland OyKuortaneenkatu   2, FI-00510 Helsinki, Finland
牙科修整用金刚砂车针国械备20240049号マニー株式会社①栃木県塩谷郡高根沢町中阿久津743②Vang   Residential Group, Tan Huong Ward, Pho Yen City, Thai Nguyen Province,   Vietnam
骨科手术器械国械备20260180号Arthrex,   Inc.见附件3
核酸提取仪国械备20230007号MP   Biomedicals Asia Pacific Pte Ltd4F.,   No. 188, Wenhe Rd, Guishan Dist., Taoyuan City 333, Taiwan
核酸提取仪国械备20230473号MP   Biomedicals Asia Pacific Pte Ltd4F.,   No. 188, Wenhe Rd, Guishan Dist., Taoyuan City 333, Taiwan
固定用弹力束带国械备20260179号Bauerfeind   AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany
手术头架国械备20240148号Black   Forest Medical GmbHB?tzinger   Strasse 86 DE 79111 Freiburg
手术头架国械备20161617号Black   Forest Medical GmbHWaldmatten   6 79224 Umkirch Germany
手动轮椅车国械备20260178号TiSport,   LLC2701   West Court St. Pasco Washington 99301 USA、300 Duke Dr LEBANON, TN,USA 37090
肌电导联线国械备20220129号 Ambu A/SLot   171, Jalan PKNK 3/8, Kawasan Perusahaan Sungai Petani, 08000 Sungai Petani,   Kedah Darul Aman, Malaysia
牙科输送器国械备20200407号Solventum   Germany GmbHRütistrasse   7, CH-9469 Haag
心电导联线 国械备20190172号GE   Healthcare Finland OyAvenida   Los Encinos Manzana #1, Lote 3, Parque, Industrial Villa Florida, Reynosa,   Tampaulipas, C.P., 88730, Mexico; 2F, No. 21 Jiankang Rd., Jhongha Dist., New   Taipei City 235, Taiwan; 177 Industrial Parkway Jackson, MN 56143 United   States
血压袖带国械备20210497号GE   Medical Systems Information Technologies, Inc.Calle   Valle Del Cedro 1551, Juarez, Mexico 32575； 1F, 2F, 5F No.21 Jiankang Rd.,   Jhonghe Dist. New Taipei City 235, Taiwan
髋关节手术工具国械备20210150号DePuy   Ireland UC请见附件“生产地址”。
腰部固定器国械备20260177号NIPPON   SIGMAX CO., LTD.Phu   Thinh Industrial Group Phu Thinh District Quang Nam Province; JL. RAYA   COMAL-PEMALANG, KM 15, UJUNG GEDE, AMPEL GADING, PEMALANG 52364, CENTRAL JAVA
鼻组织钳国械备20180409号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
手术刀国械备20170489号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
导引针国械备20171182号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
耳鼻喉用钳国械备20161985号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
骨凿国械备20171033号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
手术头架国械备20170023号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
止血钳国械备20161356号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
喉镜国械备20181530号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
骨科用手术工具国械备20260176号Medtronic   Sofamor Danek USA, Inc.4340   Swinnea Road, Memphis TN 38118, USA
基础外科手术器械国械备20260175号NORFOLK   INTERNATIONALHussaini   Road,Muzaffar Pur,Sialkot-51310,Pakistan
E-Cadherin 抗体试剂（免疫组织化学）国械备20180331号Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States
鼻窦冲吸器国械备20150358号贝斯美德股份有限公司新北市五股區五工二路116巷5號  No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku   District, New Taipei City, Taiwan 24888
皮肤组织钻孔器国械备20181213号LeadM#604，5F，6   Seocho-daero 34-gil，Seocho-gu Seoul
透析用废液袋国械备20151143号Gambro   Dasco S.p.A.Via   Modeness 66, Medolla, Modena, 41036, Italy
透析用废液袋国械备20210600号Gambro   Dasco S.p.A Medolla Facility Stegne   11 Ljubljana 1000 Slovenia
高速台式冷冻离心机国械备20260174号Thermo   Electron LED GmbH Zweigniederlassung OsterodeAm   Kalkberg 37520 Osterode am Harz Germany
高速台式离心机国械备20260173号Thermo   Electron LED GmbH Zweigniederlassung OsterodeAm   Kalkberg 37520 Osterode am Harz Germany
血型及配血离心孵育工作组 国械备20140148 号Ortho-Clinical   Diagnostics2400   Millbrook Drive, Buffalo Grove, IL 60089, USA
种植用手术导板国械备20180303号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
正畸托槽定位器国械备20181500号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
模型树脂国械备20200195号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
模型树脂国械备20200197号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
模型树脂国械备20190188号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
模型树脂国械备20190433号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
硅橡胶复制材料国械备20170956号Vertex-Dental   B.V.Centurionbaan   190, 3769 AV Soesterberg, The Netherlands
固定钉国械备20260172号Biomet   Orthopedics56   East Bell Drive, P. O. Box 587, Warsaw Indiana 46581 USA
螺丝起国械备20250444号BioMaterials   Korea, Inc.#329,   #331, #413, 150, Jojeong-daero, Hanam-si, Gyeonggi-do, Korea Rep.
螺丝起国械备20250445号BioMaterials   Korea, Inc.#329,   #331, #413, 150, Jojeong-daero, Hanam-si, Gyeonggi-do, Korea Rep.
正畸钳国械备20170044号WORLD   BIO TECH CO., LTD.BizCenter-302,(Sangdaewon-dong,   SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do
打磨抛光组件国械备20170041号WORLD   BIO TECH CO., LTD.BizCenter-302,(Sangdaewon-dong,   SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do
真空垫国械备20230557号Qfix 440   Church Road Avondale Pennsylvania 19311 USA
定位膜国械备20230556号Qfix440   Church Road Avondale Pennsylvania 19311 USA
放射治疗患者用定位装置国械备20240042号Qfix440   Church Road Avondale Pennsylvania 19311 USA
人体定位袋国械备20260171号Qfix440   Church Rd Avondale PA 19311-9786    United States of America
膝关节手术工具国械备20181669号Meril   Healthcare Pvt. Ltd.First   Floor, H1-H3, Meril Park, Survey No 135/2/B & 174/2, Muktanand Marg,   Chala,Vapi, Gujarat, India - 396191
钙石灰国械备20161496号Dr?gerwerk   AG & Co. KGaARevalstra?e   1, 23560 Lübeck, Germany
钠石灰国械备20160332号Dr?gerwerk   AG & Co. KGaARevalstra?e   1, 23560 Lübeck, Germany
医用踝部固定器国械备20260170号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany 
医用髋部固定器国械备20260169号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany 
医用手指固定器国械备20260168号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany
医用膝部固定器国械备20260167号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany 
医用肩部固定器国械备20260166号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany 
医用踝部固定器国械备20260165号 SPORLASTIC GmbH & Co. KG Weberstra?e   1, 72622 Nürtingen, Germany
医用踝部固定器国械备20260164号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany
医用颈部固定器国械备20260163号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany
医用踝部固定器国械备20260162号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany
医用踝部固定器国械备20260161号SPORLASTIC   GmbH & Co. KGWeberstra?e   1, 72622 Nürtingen, Germany
试色糊剂国械备20181138号Kerr   Corporation1717   West Collins Avenue Orange California 92867 USA
增强液国械备20150676号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland
增强液国械备20151616号Wallac   Oy华莱克有限公司
大容量低速冷冻离心机国械备20260160号株式会社久保田製作所群馬県藤岡市中大塚1065-3
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   Korea
口腔材料注射头国械备20260159号株式会社ジーシーデンタルプロダクツ愛知県春日井市鳥居松町2丁目285番地 
口腔材料注射头国械备20260158号株式会社ジーシー静岡県駿東郡小山町中日向584-1
压力腿套国械备20220590号Cardinal   Health 200，LLC 见附页。
颈部固定器国械备20170969号Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany
定位膜国械备20160834号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium
血红蛋白检测用装载片国械备20260157号DiaSpect   Medical GmbHEbendorfer   Chaussee 3, 39179 Barleben, GERMANY
显微止血夹国械备20161873号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
咬骨钳国械备20162007号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
骨用牵开器国械备20171031号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
医用镊国械备20170954号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
拉钩国械备20170135号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
牙科开口器国械备20191220号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
外科牵开器国械备20190591号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
骨凿国械备20171181号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
组织钳国械备20161919号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
显微止血夹国械备20180573号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
剥离器国械备20170488号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
器械钳国械备20170712号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
探针国械备20170778号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
钢丝钳国械备20170713号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
医用剪国械备20161704号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
持针钳国械备20170770号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
骨科用电锯片国械备20220135号MEDICON   eGG?ns?cker   15 78532 Tuttlingen GERMANY
脊柱牵开器国械备20210102号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
动脉瘤夹钳国械备20161305号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
产钳国械备20181177号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
骨锉国械备20170134号MEDICON   eGG?ns?cker   15, 78532 Tuttlingen, GERMANY
CD45抗体试剂国械备20260156号BioLegend,Inc.8999   BioLegend Way, San Diego, CA USA 92121
CD4抗体试剂国械备20260155号BioLegend,Inc.8999   BioLegend Way, San Diego, CA USA 92121
牙科种植用扳手国械备20260154号GENOSS   Co., Ltd1.   4F, 5F, D-Factory, 56, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si,   Gyeonggi-do, Republic of Korea; 2. Part of the 14F, 76 Changnyong-daero,   256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea;
医用干式银盐胶片国械备20230073号AGFA   NVSeptestraat   27, 2640 Mortsel , Belgium  1658 Bushy   Park Road, Goose Creek, South Carolina 29445, USA
医用干式胶片国械备20200133号Agfa   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA
医用干式激光胶片国械备20240406号Agfa   NV Septestraat 27, 2640 Mortsel  Belgium ；1658 Bushy Park Road, Goose   Creek,  South Carolina 29445, USA
医用干式直热银盐胶片国械备20170975号AGFA   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA
医用干式胶片国械备20170974号Agfa   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA
医用干式直热银盐胶片国械备20170755号AGFA   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA
医用干式胶片国械备20170743号AGFA   NVSeptestraat   27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina   29445, USA
医用干式胶片国械备20170052号Agfa   NVSeptestraat   27, 2640 Mortsel, Belgium 2; 1658 Bushy Park Road, Goose Creek, South   Carolina 29445, USA
CD4检测试剂国械备20210072号Becton,   Dickinson and Company, BD Biosciences2350   Qume Drive San Jose, California 95131, USA；Vicks Drive, Lot 1 Corner Road   735, Cayey 00736 Puerto Rico

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