来自国家药监局2026年4月8日公开披露的数据，2026年3月国家药监局批准206进口第一类医疗器械产品备案事项，医疗器械备案产品包括足部固定器、CD3抗体试剂、CD8抗体试剂、CD7抗体试剂、CD23抗体试剂、CD33抗体试剂、CD56抗体试剂、CD11c抗体试剂、扩肛器、钻针深度停止器等，一起来看具体内容。
2026年3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备案日期足部固定器国械备20260078号東名ブレース株式会社2026-03-31足部固定器国械备20260077号東名ブレース株式会社2026-03-31CD3抗体试剂（流式细胞仪法- APC-Alexa Fluor 700）国械备20260076号Immunotech SAS A Beckman Coulter Company2026-03-31CD8抗体试剂（流式细胞仪法-Krome Orange）国械备20260075号Immunotech SAS A Beckman Coulter Company2026-03-31CD7抗体试剂（流式细胞仪法-Pacific Blue）国械备20260074号Immunotech SAS A Beckman Coulter Company2026-03-31CD23抗体试剂（流式细胞仪法- APC）国械备20260073号Immunotech SAS A Beckman Coulter Company2026-03-31CD33抗体试剂（流式细胞仪法- APC-Alexa Fluor 750）国械备20260072号Immunotech SAS A Beckman Coulter Company2026-03-31CD56抗体试剂（流式细胞仪法- APC-Alexa Fluor 750）国械备20260071号Immunotech SAS A Beckman Coulter Company2026-03-31CD14抗体试剂（流式细胞仪法-PC7）国械备20260070号Immunotech SAS A Beckman Coulter Company2026-03-31CD11c抗体试剂（流式细胞仪法-PC5.5）国械备20260069号Immunotech SAS A Beckman Coulter Company2026-03-31扩肛器国械备20200246号KARL STORZ SE & Co. KG2026-03-31钻针深度停止器国械备20240312号Anthogyr2026-03-31试戴体国械备20200271号Anthogyr2026-03-31牙科种植器械限深套国械备20200124号Anthogyr2026-03-31种植手术工具包国械备20181582号Anthogyr2026-03-31种植体布置辅助器械国械备20181502号Anthogyr2026-03-31种植体布置辅助器械国械备20181501号Anthogyr2026-03-31牙科塑料基底国械备20181324号Anthogyr2026-03-31牙科种植扫描定位件国械备20181322号Anthogyr2026-03-31牙科手术通用器械包国械备20180323号Anthogyr2026-03-31牙科种植手术工具包国械备20171180号Anthogyr2026-03-31牙用尺国械备20171039号Anthogyr2026-03-31牙用刀国械备20170979号Anthogyr2026-03-31种植辅助器械国械备20170978号Anthogyr2026-03-31转移帽国械备20170216号Anthogyr2026-03-31种植体扫描体国械备20191124号ARUM DENTISTRY Co., Ltd.2026-03-30组织微阵列制作仪国械备20151662号3DHISTECH Kft.2026-03-30集尿袋国械备20170831号BICAKCILAR Tibbi Cihazlar Sanayi ve Ticaret A.S.2026-03-30钙石灰国械备20160777号Molecular Products Ltd2026-03-30人类白细胞抗原DR抗体试剂（流式细胞仪法-PC5.5）国械备20260068号Immunotech SAS A Beckman Coulter Company2026-03-27CD14抗体试剂（流式细胞仪法-PC5.5）国械备20260067号Immunotech SAS A Beckman Coulter Company2026-03-27流式细胞研究用鞘液国械备20260066号Beckman Coulter, Inc.2026-03-27代型材料国械备20170809号Covestro (Netherlands) B.V.2026-03-26腹部造口弹性绷带国械备20200551号Tytex A/S2026-03-26生物显微镜国械备20250354号株式会社エビデント2026-03-26生物显微镜国械备20210399号株式会社エビデント2026-03-26生物显微镜国械备20210293号株式会社エビデント2026-03-26生物显微镜国械备20210552号株式会社エビデント2026-03-26生物显微镜国械备20210550号株式会社エビデント2026-03-26生物显微镜国械备20210398号株式会社エビデント2026-03-26生物显微镜国械备20210553号株式会社エビデント2026-03-26生物显微镜国械备20210551号株式会社エビデント2026-03-26生物显微镜国械备20210287号株式会社エビデント2026-03-26聚氨酯衬垫绷带国械备20170868号PAUL HARTMANN AG2026-03-26口腔科用材料混合注射头国械备20260065号ZHERMACK S.p.A2026-03-26印模材料口内注射头国械备20220517号ZHERMACK S.p.A2026-03-26打磨抛光器具国械备20260064号Dr. Hopf GmbH & Co. KG2026-03-26基础外科手术器械国械备20260063号ENIKA INDUSTRIES2026-03-26医用检查手套国械备20260062号HTC GLOVES JOINT STOCK COMPANY2026-03-26下肢支具国械备20191150号medi GmbH & Co.KG2026-03-26弹力绷带国械备20191151号medi GmbH & Co.KG2026-03-26膝部固定器国械备20191154号medi GmbH & Co.KG2026-03-26可挤压式四肢压力带国械备20191251号medi GmbH & Co.KG2026-03-26肘部固定器国械备20191152号medi GmbH & Co.KG2026-03-26髋部固定器国械备20191153号medi GmbH & Co.KG2026-03-26背部支具国械备20140078号Medi GmbH & Co.KG2026-03-26肩部固定器国械备20191149号medi GmbH & Co.KG2026-03-26医用足部护具国械备20190690号medi GmbH & Co.KG2026-03-26医用踝关节护具国械备20190691号medi GmbH & Co.KG2026-03-26背部固定器国械备20191146号medi GmbH & Co.KG2026-03-26医用脚踝部护具国械备20190688号medi GmbH & Co.KG2026-03-26口腔科手术器械国械备20240162号Naseem Enterprises2026-03-25医用检查手套国械备20260061号SUPERMAX GLOVE MANUFACTURING SDN.BHD.2026-03-24牙科手术器械包国械备20181728号Polydentia SA2026-03-24牙科抛光条国械备20210116号Polydentia SA2026-03-24牙科器械钳国械备20181726号Polydentia SA2026-03-24快接头国械备20240045号Synthes GmbH2026-03-24检查手套国械备20170721号Medline Industries, LP2026-03-24检查手套国械备20170722号Medline Industries, LP2026-03-24牙科吸潮纸尖国械备20260060号Alfred Becht GmbH2026-03-23一次性使用细胞过滤采集器国械备20160620号Hologic, Inc.2026-03-23CD10抗体试剂（免疫组织化学）国械备20180260号Ventana Medical Systems, Inc.2026-03-23TRPS1抗体试剂（免疫组织化学)国械备20260059号Ventana Medical Systems, Inc.2026-03-23高分子固定绷带国械备20260058号BSN medical GmbH2026-03-23牙用尺国械备20170166号Institut Straumann AG2026-03-23医用外固定支具国械备20161152号DJO,LLC2026-03-19剔挖器国械备20161950号株式会社YDM2026-03-19牙科用咬骨钳国械备20170031号株式会社YDM2026-03-19基础外科手术器械包国械备20170015号株式会社YDM2026-03-19牙探针国械备20161584号株式会社YDM2026-03-19牙科开口器国械备20170616号株式会社YDM2026-03-19牙科种植辅助工具国械备20181693号Neoss AB2026-03-19牙刮匙国械备20161951号株式会社YDM2026-03-18牙科刮治器 国械备20161891 号株式会社YDM2026-03-18牙科用分离器国械备20162013号株式会社YDM2026-03-18口腔麻醉手动注射架国械备20181347号株式会社YDM2026-03-18牙科种植体种植工具国械备20220576号BASIC DENTAL IMPLANT SYSTEMS,INC.2026-03-18基础外科手术器械国械备20161358号CM Instrumente GmbH2026-03-18口镜国械备20161705号株式会社YDM2026-03-18拔牙钳国械备20170565号株式会社YDM2026-03-18成形片夹国械备20170714号株式会社YDM2026-03-18牙挺国械备20162011号株式会社YDM2026-03-18牙科用剪国械备20170030 号株式会社YDM2026-03-18牙科用镊国械备20161892号株式会社YDM2026-03-18吸引管国械备20161904 号株式会社YDM2026-03-18牙科去冠器 国械备20170715 号株式会社YDM2026-03-18牙用充填器国械备20161786号株式会社YDM2026-03-18正畸钳国械备20161162号株式会社YDM2026-03-18口腔科手术器械包国械备20170745 号株式会社YDM2026-03-18弹性绷带国械备20170141号Medi GmbH & Co. KG2026-03-17臂部支具国械备20140080号Medi GmbH & Co.KG2026-03-17肩部与脊柱护具国械备20150272号Medi GmbH & Co.KG2026-03-17肩关节固定器国械备20180413号Medi GmbH & Co.KG2026-03-17腰椎固定器国械备20180414号Medi GmbH & Co.KG2026-03-17背部护具国械备20150271号Medi GmbH & Co.KG2026-03-17肩部支具国械备20140079号Medi GmbH & Co.KG2026-03-17臀部支具国械备20140077号Medi GmbH & Co.KG2026-03-17肩关节固定器国械备20180469号Medi GmbH & Co.KG2026-03-17牙科修整用金刚砂车针国械备20240049号マニー株式会社2026-03-17脚踝部护具国械备20150273号Medi GmbH & Co.KG2026-03-17CD71抗体试剂（流式细胞仪法-SNv428）国械备20260057号Immunotech SAS A Beckman Coulter Company2026-03-17CD23抗体试剂（流式细胞仪法-SNv428）国械备20260056号Immunotech SAS A Beckman Coulter Company2026-03-17CD13抗体试剂（流式细胞仪法-SNv428）国械备20260055号Immunotech SAS A Beckman Coulter Company2026-03-17牙科修整用金刚砂车针国械备20260054号3R Industria e Comercio Ltda2026-03-16自粘弹力绷带国械备20190185号Cre-Med, LLC2026-03-16器械连接杆国械备20260053号Medtronic Navigation, Inc.2026-03-16牙科用锉国械备20151514号BEGO Implant Systems GmbH & Co. KG2026-03-13超声洁牙机工作尖国械备20210338号E.M.S. Electro Medical Systems S.A.2026-03-12胸腔心血管外科手术器械国械备20200391号CM Instrumente GmbH2026-03-12核酸提取或纯化试剂国械备20181608号QIAGEN GmbH2026-03-12替代体国械备20181232号BEGO Implant Systems GmbH & Co.KG2026-03-11牙科种植手术修复工具包国械备20160873号BEGO Implant Systems GmbH & Co. KG2026-03-11清洗液 BOND Wash Solution 10X Concentrate国械备20150492号Leica Biosystems Newcastle Ltd2026-03-11原位杂交用蛋白酶 BOND Enzyme Pretreatment Kit国械备20150495号Leica Biosystems Newcastle Ltd2026-03-11免疫组化抗原修复缓冲液国械备20150540号Leica Biosystems Newcastle Ltd2026-03-11压力绷带国械备20161480号Medi GmbH & Co. KG2026-03-11弹性绷带国械备20170061号Medi GmbH & Co. KG2026-03-11膝盖护具国械备20150270号Medi GmbH & Co.KG2026-03-11膝盖支具国械备20140071号Medi GmbH & Co.KG2026-03-11膝关节固定器国械备20180411号Medi GmbH & Co.KG2026-03-11核酸染色液国械备20180688号?????2026-03-11医用检查手套国械备20260052号N. S. Uni-Gloves Sdn. Bhd.2026-03-11防水创口贴国械备20260051号3M Company2026-03-10牙科种植材料取出器国械备20180172号BEGO Implant Systems GmbH & Co. KG2026-03-10牙科种植手术修复工具包国械备20230243号BEGO Implant Systems GmbH & Co. KG2026-03-09牙科种植专用器械包国械备20162056号BEGO Implant Systems GmbH & Co. KG2026-03-09动脉瘤夹钳国械备20180219号Peter Lazic GmbH2026-03-06脑压板国械备20160629号Peter Lazic GmbH2026-03-06显微刀国械备20160255号Peter Lazic GmbH2026-03-06显微剪国械备20160630号Peter Lazic GmbH2026-03-06刮匙国械备20180053号Peter Lazic GmbH2026-03-06显微持针钳国械备20160631号Peter Lazic GmbH2026-03-06显微镊国械备20160633号Peter Lazic GmbH2026-03-06剥离器国械备20180617号Peter Lazic GmbH2026-03-06CD10抗体试剂（免疫组织化学）国械备20220177号Agilent Technologies Singapore (International) Pte. Ltd.2026-03-05清洗液国械备20140354号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05苏木素染色液国械备20140353号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05免疫组化抗原修复缓冲液 EnVision FLEX Target Retrieval Solution, High pH (50x) (Dako Omnis)国械备20140002号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05免疫组化抗原修复缓冲液 EnVision FLEX Target Retrieval Solution, Low pH (50x) (Dako Omnis)国械备20140012号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05增强液 EnVision FLEX+ Rabbit LINKER (Dako Omnis)国械备20140028号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05增强液国械备20190907号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05免疫显色试剂 EnVision FLEX, High pH(Dako Omnis)EnVision FLEX Mini Kit, High pH(Dako Omnis)国械备20140301号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05DAB染色液EnVision FLEX DAB+ Substrate Chromogen System (Dako Omnis)国械备20140351号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05免疫显色试剂国械备20190912号Agilent Technologies Singapore (International) Pte Ltd.2026-03-05正畸钳国械备20170044号WORLD BIO TECH CO., LTD.2026-03-05打磨抛光组件国械备20170041号WORLD BIO TECH CO., LTD.2026-03-05牙科种植导板国械备20200269号Sirona Dental Systems GmbH2026-03-05跗骨手术工具国械备20210167号GraMedica2026-03-05全自动样本处理及孵育系统国械备20160837号Hologic,Inc.2026-03-05末端脱氧核苷酸转移酶（TdT）抗体试剂国械备20260050号BioLegend,Inc.2026-03-05颗粒酶B（GranzymeB）抗体试剂（流式细胞仪法）国械备20260049号BioLegend,Inc.2026-03-05颗粒酶B（GranzymeB）抗体试剂（流式细胞仪法）国械备20260048号BioLegend,Inc.2026-03-05末端脱氧核苷酸转移酶（TdT）抗体试剂国械备20260047号BioLegend,Inc.2026-03-05人类白细胞抗原DR抗体试剂国械备20260046号BioLegend,Inc.2026-03-05MLH1抗体试剂（免疫组织化学）国械备20230308号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04MSH2抗体试剂（免疫组织化学）国械备20230273号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04MSH6抗体试剂（免疫组织化学）国械备20230274号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04细胞角蛋白（高分子量）抗体试剂（免疫组织化学）国械备20180336号Agilent Technologies, Inc.2026-03-04HMB-45抗体试剂（免疫组织化学）FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB-45, Ready-to-Use (Dako Omnis)国械备20180330号Agilent Technologies, Inc.2026-03-04细胞角蛋白（广谱）抗体试剂（免疫组织化学）国械备20180338号Agilent Technologies, Inc.2026-03-04E-Cadherin 抗体试剂（免疫组织化学）国械备20180331号Agilent Technologies, Inc.2026-03-04细胞周期蛋白D1抗体试剂（免疫组织化学）国械备20180720号Agilent Technologies, Inc.2026-03-04AMACR/p504s抗体试剂（免疫组织化学）国械备20180329号Agilent Technologies, Inc.2026-03-04CD15抗体试剂（免疫组织化学）国械备20180333号Agilent Technologies, Inc.2026-03-04CDX-2抗体试剂（免疫组织化学）国械备20180771号Agilent Technologies, Inc.2026-03-04Ki-67抗体试剂（免疫组织化学）国械备20180353号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04EMA抗体试剂（免疫组织化学）国械备20180721号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04Vimentin抗体试剂（免疫组织化学）国械备20180370号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04CD34抗体试剂（免疫组织化学）国械备20180373号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04CD43抗体试剂（免疫组织化学）国械备20190527号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04Ber-EP4抗体试剂（免疫组织化学）国械备20230110号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04CD138抗体试剂（免疫组织化学）国械备20180737号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04CD7抗体试剂（免疫组织化学）国械备20230104号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04MUM1抗体试剂（免疫组织化学）国械备20180780号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04Pax-5抗体试剂（免疫组织化学）国械备20180364号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04CD2抗体试剂（免疫组织化学）国械备20190519号Agilent Technologies Singapore (International) Pte Ltd.2026-03-04颗粒酶B（GranzymeB）抗体试剂（流式细胞仪法）国械备20260045号BioLegend,Inc.2026-03-03牵开器国械备20200687号CM Instrumente GmbH2026-03-03骨科外固定夹板国械备20210285号THUASNE2026-03-03口腔科器械国械备20260044号BRENNER IMPORT AND EXPORT COMPANY LIMITED2026-03-03口腔科手术器械国械备20240240号NIBBLE SURGICAL2026-03-03医用射线防护用品国械备20160563号Dr.Goos - Suprema GmbH2026-03-02模型树脂国械备20260043号dentona AG2026-03-02模型树脂国械备20260042号dentona AG2026-03-02创口贴国械备20181738号3M Deutschland GmbH2026-03-02牙科开口器国械备20260041号Ivoclar Vivadent AG2026-03-02CA 125抗体试剂（免疫组织化学）国械备20190529号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02Synaptophysin抗体试剂（免疫组织化学）国械备20180741号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02p63抗体试剂（免疫组织化学）国械备20180714号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02巨细胞病毒抗体试剂（免疫组织化学）国械备20230106号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02ERG抗体试剂（免疫组织化学）国械备20230109号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02CD45抗体试剂（免疫组织化学）国械备20180349号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02细胞角蛋白20抗体试剂（免疫组织化学）国械备20180389号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02CD23抗体试剂（免疫组织化学）国械备20180747号Agilent Technologies Singapore (International) Pte Ltd.2026-03-02p40抗体试剂（免疫组织化学）国械备20220172号Agilent Technologies Singapore (International) Pte. Ltd.2026-03-02ALK抗体试剂（免疫组织化学）国械备20220152号Agilent Technologies Singapore (International) Pte. Ltd.2026-03-02如有进口第一类医疗器械产品备案、进口医疗器械注册代理、进口医疗器械转国产咨询服务需求，欢迎您随时方便与北京飞速度医疗科技有限公司联络，联系人：施经理，电话：19103801095，微信同。
1147
