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2025年7月國(guó)家局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案135項(xiàng)
發(fā)布日期:2025-08-19 21:06瀏覽次數(shù):63次
來(lái)自國(guó)家藥監(jiān)局近日披露的數(shù)據(jù)，2025年7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135項(xiàng)，其中包括醫(yī)用射線防護(hù)眼鏡、口腔沖洗針、口腔科手術(shù)器械、彈性繃帶、牙科種植專用器械包、喉鏡、口腔燈、血細(xì)胞分析用染色液等眾多一類醫(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)局近日披露的數(shù)據(jù)，2025年7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135項(xiàng)，其中包括醫(yī)用射線防護(hù)眼鏡、口腔沖洗針、口腔科手術(shù)器械、彈性繃帶、牙科種植專用器械包、喉鏡、口腔燈、血細(xì)胞分析用染色液等眾多一類醫(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7月國(guó)家局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案135項(xiàng)產(chǎn)品清單

醫(yī)療器械產(chǎn)品名稱醫(yī)療器械備案號(hào)醫(yī)療器械備案人名稱原文備案日期
血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20151446號(hào)Abbott   Laboratories2025-07-31 
血細(xì)胞分析用鞘液國(guó)械備20151245號(hào)Abbott   Laboratories2025-07-31 
血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20151275號(hào)Abbott   Laboratories2025-07-31 
血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20151276號(hào)Abbott   Laboratories2025-07-31 
血細(xì)胞分析用稀釋液國(guó)械備20151246號(hào)Abbott   Laboratories2025-07-31 
血細(xì)胞分析用染色液國(guó)械備20151285號(hào)Abbott   Laboratories2025-07-31 
血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20151284號(hào)Abbott   Laboratories2025-07-31 
口腔治療器具國(guó)械備20250244號(hào)Trephine   International2025-07-31 
口腔科器械國(guó)械備20250243號(hào)H&H   INSTRUMENTS MFG CO.2025-07-30 
樣本稀釋液國(guó)械備20170172號(hào)Beckman   Coulter, Inc. 2025-07-30 
喉鏡國(guó)械備20250242號(hào)Surgical   Sources industries2025-07-29 
口腔燈國(guó)械備20170500號(hào)Osstem   Implant Co., Ltd.2025-07-29 
代型材料國(guó)械備20171109號(hào)Osstem   Implant Co., Ltd.2025-07-29 
檢查手套國(guó)械備20191218號(hào)Mexpo   International Inc.2025-07-29 
醫(yī)用退熱貼 國(guó)械備20181316號(hào)日本池田株式會(huì)社2025-07-28 
位置定位器國(guó)械備20160011號(hào)Osstem   Implant Co.,Ltd.2025-07-25 
免疫檢驗(yàn)系統(tǒng)用底物液國(guó)械備20250241號(hào)Ventana   Medical Systems, Inc.2025-07-25 
地高辛顯色試劑國(guó)械備20250240號(hào)Ventana   Medical Systems, Inc.2025-07-25 
EBER 探針試劑（原位雜交法）國(guó)械備20250239號(hào)Roche   Diagnostics GmbH2025-07-25 
踝部固定器國(guó)械備20220072號(hào)?ssur   hf2025-07-24 
基礎(chǔ)外科手術(shù)器械國(guó)械備20250238號(hào)Sabri   Industries2025-07-24 
口腔治療器具國(guó)械備20250237號(hào)Sabri   Industries2025-07-24 
正畸自鎖托槽開啟器國(guó)械備20210533號(hào)GNI   Co., Ltd.2025-07-24 
口腔科手術(shù)器械國(guó)械備20250235號(hào)VENUS   ENTERPRISES2025-07-23 
醫(yī)用離心機(jī) 國(guó)械備20150269號(hào)Cytori   Therapeutics, Inc.2025-07-23 
核酸純化試劑 Nucleic Acid Purification Reagent國(guó)械備20150330號(hào)Cytori   Therapeutics, Inc.2025-07-23 
多肽純化試劑 Polypeptide Purification Reagent國(guó)械備20150329號(hào)Cytori   Therapeutics, Inc.2025-07-23 
隔離護(hù)罩國(guó)械備20191096號(hào)Polydentia   SA2025-07-23 
成形片國(guó)械備20180652號(hào)Polydentia   SA2025-07-23 
楔子國(guó)械備20181129號(hào)Polydentia   SA2025-07-23 
口腔科手術(shù)器械國(guó)械備20230075號(hào)ASAS   AND BROTHERS ENTERPRISES2025-07-23 
口腔科手術(shù)器械國(guó)械備20230419號(hào)MED   PLAY INSTRUMENTS2025-07-21 
硅油推力架國(guó)械備20190182號(hào)ARCADOPHTA   SARL2025-07-21 
醫(yī)用射線防護(hù)服國(guó)械備20250234號(hào)Lanz-Anliker   AG2025-07-21 
牙科種植用深度測(cè)量尺國(guó)械備20240217號(hào)???????(?)2025-07-21 
血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20140184號(hào)Beckman   coulter, Inc.2025-07-21 
種植體掃描體國(guó)械備20240214號(hào)???????(?)2025-07-21 
血細(xì)胞分析用染色液國(guó)械備20151293號(hào)Beckman   coulter, Inc.2025-07-21 
種植體安裝輔助器械國(guó)械備20240212號(hào)???????(?)2025-07-21 
尿液分析用鞘液 iQ? LaminaTM國(guó)械備20150059號(hào)Beckman   Coulter Ireland Inc.2025-07-21 
緩沖液槽（陰極緩沖液槽） Cathode Buffer Container Dx國(guó)械備20160974號(hào) Life Technologies Holdings Pte Ltd 2025-07-21 
陽(yáng)極緩沖液槽 Anode Buffer Container Dx國(guó)械備20160445號(hào)Life   Technologies Holdings Pte Ltd2025-07-21 
甲酰胺進(jìn)樣溶劑 Hi-Di? Formamide Dx 國(guó)械備20160320號(hào) Life   Technologies Holdings Pte Ltd2025-07-21 
鉆針深度停止器國(guó)械備20240216號(hào)???????(?)2025-07-21 
牙科用鑷國(guó)械備20240211號(hào)???????(?)2025-07-21 
轉(zhuǎn)移體國(guó)械備20240215號(hào)???????(?)2025-07-21 
牙科種植導(dǎo)板固定螺絲國(guó)械備20240213號(hào)???????(?)2025-07-21 
醫(yī)用放大鏡國(guó)械備20191216號(hào)(?)??????2025-07-17 
醫(yī)用超聲波清洗器國(guó)械備20250233號(hào)Getinge   Disinfection AB2025-07-17 
牙用分離器國(guó)械備20151443號(hào)Hu-Friedy   Mfg. Co., LLC2025-07-17 
轉(zhuǎn)移帽國(guó)械備20160722號(hào)ORNAGHI   LUIGI & C.s.n.c. 2025-07-15 
牙用尺國(guó)械備20151969號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-15 
鉆針深度停止器國(guó)械備20152009號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-15 
螺絲起國(guó)械備20151966號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-15 
轉(zhuǎn)移帽國(guó)械備20160721號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-15 
牙科用軟組織環(huán)切刀國(guó)械備20151967號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-15 
高速冷凍離心機(jī)國(guó)械備20250232號(hào)Sigma-Laborzentrifugen   GmbH2025-07-15 
托足架國(guó)械備20250231號(hào)CONDOR   MedTec GmbH2025-07-15 
替代體國(guó)械備20181180號(hào)ORNAGHI   LUIGI & C.S.n.c.2025-07-14 
替代體國(guó)械備20181179號(hào)ORNAGHI   LUIGI & C.S.n.c.2025-07-14 
牙科種植定位器國(guó)械備20151971號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-14 
替代體國(guó)械備20181178號(hào)ORNAGHI   LUIGI & C.S.n.c.2025-07-14 
扭力扳手國(guó)械備20151965號(hào)ORNAGHI   LUIGI & C.s.n.c.2025-07-14 
牙科種植用延長(zhǎng)器國(guó)械備20200258號(hào)ORNAGHI   LUIGI & C. S.n.c.2025-07-14 
正畸鉗國(guó)械備20250230號(hào)GNI   Co., Ltd.2025-07-14 
彈性繃帶國(guó)械備20161128號(hào)PAUL   HARTMANN AG2025-07-14 
轉(zhuǎn)移帽國(guó)械備20161140號(hào)DIO   Corporation2025-07-10 
種植體掃描體國(guó)械備20161179號(hào)DIO   Corporation2025-07-10 
牙科種植專用器械包國(guó)械備20161332號(hào)DIO   Corporation2025-07-10 
置骨器國(guó)械備20161272號(hào)Hu-Friedy   Mfg.Co.,LLC2025-07-10 
S100抗體試劑國(guó)械備20250229號(hào)Cell   Marque Corporation2025-07-10 
CD45抗體試劑國(guó)械備20250228號(hào)Cell   Marque Corporation2025-07-10 
MSH2抗體試劑國(guó)械備20250227號(hào)Cell   Marque Corporation2025-07-10 
甲狀腺轉(zhuǎn)錄因子-1（TTF-1）抗體試劑國(guó)械備20250226號(hào)Cell   Marque Corporation2025-07-10 
異檸檬酸脫氫酶1（IDH-1）抗體試劑國(guó)械備20250225號(hào)Cell   Marque Corporation2025-07-10 
IV型膠原（Collagen Type IV）抗體試劑國(guó)械備20250224號(hào)Cell   Marque Corporation2025-07-10 
MSH6抗體試劑國(guó)械備20250223號(hào)Cell   Marque Corporation2025-07-10 
SV-40抗體試劑國(guó)械備20250222號(hào)Cell   Marque Corporation2025-07-10 
補(bǔ)體C4d抗體試劑國(guó)械備20250221號(hào)Cell   Marque Corporation2025-07-09 
PMS2抗體試劑國(guó)械備20250220號(hào)Cell   Marque Corporation2025-07-09 
錯(cuò)配修復(fù)蛋白（MLH1）抗體試劑國(guó)械備20250219號(hào)Cell   Marque Corporation2025-07-09 
突觸素（Synaptophysin）抗體試劑國(guó)械備20250218號(hào)Cell   Marque Corporation2025-07-09 
ATRX抗體試劑國(guó)械備20250217號(hào)Cell   Marque Corporation2025-07-09 
CD4抗體試劑國(guó)械備20250216號(hào)Cell   Marque Corporation2025-07-09 
胰島素瘤相關(guān)蛋白1（INSM1）抗體試劑國(guó)械備20250215號(hào)Cell   Marque Corporation2025-07-09 
CD94檢測(cè)試劑（流式細(xì)胞儀法）國(guó)械備20250214號(hào)BioLegend,Inc.2025-07-09 
STAT6抗體試劑國(guó)械備20250213號(hào)Cell   Marque Corporation2025-07-09 
CD94檢測(cè)試劑（流式細(xì)胞儀法)國(guó)械備20250212號(hào)BioLegend,Inc.2025-07-09 
CD45抗體試劑國(guó)械備20250211號(hào)BioLegend,Inc.2025-07-09 
CD24抗體試劑（流式細(xì)胞儀法）國(guó)械備20250210號(hào)BioLegend,Inc.2025-07-09 
p16抗體試劑國(guó)械備20250209號(hào)Cell   Marque Corporation2025-07-09 
CD127抗體試劑國(guó)械備20250208號(hào)BioLegend,Inc.2025-07-09 
CD197檢測(cè)試劑（流式細(xì)胞儀法)國(guó)械備20250207號(hào)BioLegend,Inc.2025-07-09 
IgM抗體試劑（流式細(xì)胞儀法）國(guó)械備20250206號(hào)BioLegend,Inc.2025-07-09 
TCRαβ抗體試劑（流式細(xì)胞儀法）國(guó)械備20250205號(hào)BioLegend,Inc.2025-07-09 
末端脫氧核苷酸轉(zhuǎn)移酶（TdT）抗體試劑國(guó)械備20250204號(hào)BioLegend,Inc.2025-07-09 
冷凍包埋劑國(guó)械備20250203號(hào)Richard-Allan   Scientific LLC2025-07-09 
連接桿國(guó)械備20250202號(hào)Aesculap   AG2025-07-08 
細(xì)菌培養(yǎng)浸片國(guó)械備20250201號(hào)Aidian   Oy2025-07-08 
大腸埃希菌尿培養(yǎng)浸片國(guó)械備20250200號(hào)Aidian   Oy2025-07-08 
抗酸染色液 AFB(Ziehl-Neelsen) Stain Reagent Kit國(guó)械備20250173號(hào)Dagatronics   Corporation 2025-07-08 
全自動(dòng)染色機(jī)國(guó)械備20250199號(hào)Dagatronics   Corporation  2025-07-08 
細(xì)胞角蛋白（廣譜）抗體試劑國(guó)械備20250198號(hào)Cell   Marque Corporation2025-07-08 
口腔科手術(shù)器械包國(guó)械備20250197號(hào)FIMS   Co., Ltd.2025-07-08 
口鏡國(guó)械備20250196號(hào)ARAMID   INDUSTRIES2025-07-08 
踝部固定器國(guó)械備20220072號(hào)?ssur   hf2025-07-08 
醫(yī)用射線防護(hù)懸吊屏風(fēng)國(guó)械備20160828號(hào)MAVIG   GmbH2025-07-04 
醫(yī)用射線防護(hù)簾國(guó)械備20160831號(hào)MAVIG   GmbH2025-07-04 
Ki-67抗體試劑國(guó)械備20250195號(hào)Cell   Marque Corporation2025-07-04 
造口袋國(guó)械備20210004號(hào)ConvaTec   Limited2025-07-04 
傷口護(hù)理軟膏國(guó)械備20190881號(hào) LABORATOIRES FANNAMEX2025-07-04 
血細(xì)胞分析用鞘液國(guó)械備20151322號(hào)Beckman   Coulter, Inc.2025-07-04 
顱頜面手術(shù)器械箱國(guó)械備20250194號(hào)General   Implants GmbH Deutschland2025-07-03 
施夾鉗(不帶夾)國(guó)械備20200365號(hào)PETERS   SURGICAL 2025-07-03 
牙科種植體器械包國(guó)械備20170242號(hào)DIO   Corporation2025-07-03 
牙科種植體手術(shù)工具國(guó)械備20140142號(hào)/2025-07-03 
種植用手術(shù)導(dǎo)板國(guó)械備20140299號(hào)/2025-07-03 
醫(yī)用轉(zhuǎn)移車 國(guó)械備20161333號(hào)普達(dá)康股份有限公司 2025-07-03 
牙科模型材料國(guó)械備20220258號(hào)DIO   Corporation2025-07-03 
模型樹脂國(guó)械備20200177號(hào)DIO   Corporation2025-07-03 
代型材料國(guó)械備20181560號(hào)DIO   Corporation2025-07-03 
預(yù)成型蠟國(guó)械備20191013號(hào)DIO   Corporation2025-07-03 
醫(yī)用X射線膠片國(guó)械備20170457號(hào)Carestream   Health, Inc.2025-07-03 
螺絲起國(guó)械備20250193號(hào)Dentos   Inc.2025-07-03 
模型樹脂國(guó)械備20181559號(hào)DIO   Corporation2025-07-02 
牙科種植導(dǎo)板國(guó)械備20181466號(hào)DIO   Corporation 2025-07-02 
口腔數(shù)字印模用開口器國(guó)械備20180420號(hào)DIO   Corporation2025-07-02 
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