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2025年4月173項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)獲批
發(fā)布日期:2025-05-16 22:33瀏覽次數(shù):94次
來自國(guó)家藥監(jiān)局2025年5月16日披露的數(shù)據(jù)，2025年4月173項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)獲批，其中，新增進(jìn)口第一類醫(yī)療器械產(chǎn)品備案54項(xiàng)；進(jìn)口第一類醫(yī)療器械產(chǎn)品備案變更112項(xiàng)；進(jìn)口第一類醫(yī)療器械產(chǎn)品備案無效7項(xiàng)。

來自國(guó)家藥監(jiān)局2025年5月16日披露的數(shù)據(jù)，2025年4月173項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)獲批，其中，新增進(jìn)口第一類醫(yī)療器械產(chǎn)品備案54項(xiàng)；進(jìn)口第一類醫(yī)療器械產(chǎn)品備案變更112項(xiàng)；進(jìn)口第一類醫(yī)療器械產(chǎn)品備案無效7項(xiàng)。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

新增進(jìn)口第一類醫(yī)療器械產(chǎn)品備案54項(xiàng)產(chǎn)品信息

醫(yī)療器械產(chǎn)品名稱醫(yī)療器械產(chǎn)品備案號(hào)備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
骨科手術(shù)器械國(guó)械備20250130號(hào)HILBRO   INTERNATIONAL (PVT) LTD.12   KM Daska Road, P.O. Box 250, Sialkot - Pakistan,2025-04-29 有效
牙科電動(dòng)抽吸系統(tǒng)國(guó)械備20250129號(hào)MGF   srlVia   Pascoli, 15-20081 Abbiategrasso (MI), Italia2025-04-28 有效
膝關(guān)節(jié)手術(shù)工具包國(guó)械備20250128號(hào)Zimmer   Inc.1800   W. Center Street, Warsaw Indiana 46580, USA2025-04-27 有效
光固化牙齦屏障樹脂國(guó)械備20250127號(hào)(?)???????   ??? ??? 3, 1?(101?), 2?2025-04-27 有效
口腔治療器具國(guó)械備20250126號(hào)ACME   ENTERPRISES3/366   Aziz Shaheed Colony Cantt, Sialkot - Pakistan2025-04-27 有效
緩沖液國(guó)械備20250125號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
緩沖液國(guó)械備20250124號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
緩沖液國(guó)械備20250123號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
緩沖液國(guó)械備20250122號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
緩沖液國(guó)械備20250121號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
緩沖液國(guó)械備20250120號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
緩沖液國(guó)械備20250119號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
待測(cè)物清洗液國(guó)械備20250118號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
基礎(chǔ)外科手術(shù)器械國(guó)械備20250117號(hào)HILBRO   INTERNATIONAL (PVT) LTD.12   KM Daska Road, P.O. Box 250, Sialkot - Pakistan,2025-04-24 有效
緩沖液國(guó)械備20250116號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
樣本萃取液國(guó)械備20250115號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
樣本稀釋液國(guó)械備20250114號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-04-24 有效
基礎(chǔ)外科手術(shù)器械國(guó)械備20250113號(hào)ARAMID   INDUSTRIESNOL   MOR,WAZIRABAD ROAD SIALKOT-PAKISTAN2025-04-21 有效
口腔科手術(shù)器械國(guó)械備20250112號(hào)HILBRO   INTERNATIONAL (PVT) LTD.12   KM Daska Road, P.O. Box 250, Sialkot - Pakistan,2025-04-16 有效
口腔科器械國(guó)械備20250111號(hào)ARAMID   INDUSTRIESNOL   MOR,WAZIRABAD ROAD SIALKOT-PAKISTAN2025-04-16 有效
脛骨可調(diào)截骨導(dǎo)向工具包國(guó)械備20250110號(hào)Enztec   Limited3/17   Print Place, Middleton, Christchurch 8024, New Zealand2025-04-16 有效
牙探針國(guó)械備20250109號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
牙科潔治器國(guó)械備20250108號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
牙骨膜分離器國(guó)械備20250107號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
口鏡國(guó)械備20250106號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
牙用充填器國(guó)械備20250105號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
牙周探針國(guó)械備20250104號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
牙刮匙國(guó)械備20250103號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
剔挖器國(guó)械備20250102號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
牙挺國(guó)械備20250101號(hào)AR   InstrumedHead   Marala Road,Murad Pur,Sialkot-51310-Pakistan2025-04-15 有效
橡皮障國(guó)械備20250100號(hào)SANCTUARY   HEALTH SDN. BHD.No.16,   Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia.2025-04-15 有效
定位螺絲國(guó)械備20250099號(hào)TruAbutment   Korea Co., Ltd.104-214~216,   101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14449, Rep. of   Korea2025-04-14 有效
替代體國(guó)械備20250098號(hào)TruAbutment   Korea Co., Ltd.104-214~216,   101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14449, Rep. of   Korea2025-04-14 有效
基礎(chǔ)外科手術(shù)器械國(guó)械備20250097號(hào)Sehar   Batool InternationalS.I.E.,   Fateh Garh, Near Umer Town, Sialkot, 51310, Pakistan2025-04-14 有效
基礎(chǔ)外科手術(shù)器械國(guó)械備20250096號(hào)RB   Medikal InstrumentsS.I.E.,   Fateh Garh, Near Umer Town, Sialkot, 51310, Pakistan2025-04-14 有效
NUT（15q14）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20250095號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-11 有效
p16基因探針試劑 （熒光原位雜交法）國(guó)械備20250094號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-11 有效
MAML2（11q21）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20250093號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-11 有效
PDGFB（22q13）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20250092號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-11 有效
基礎(chǔ)外科手術(shù)器械國(guó)械備20250091號(hào)Best   Health CareMuhammad   Pura, Commissioner Road, Sialkot-51310-Pakistan2025-04-11 有效
MYC（8q24）基因擴(kuò)增探針試劑（熒光原位雜交法）國(guó)械備20250090號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-10 有效
BCL2（18q21）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20250089號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-10 有效
TERT（5p15）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20250088號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-10 有效
USP6（17p13）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20250087號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2025-04-10 有效
基礎(chǔ)外科手術(shù)器械國(guó)械備20250086號(hào)S.A.Q.   JILLANI INSTRUMENTSP.O.Box   1545 Umar Pura, Marjan Road, Ugoki 51310 Sialkot Pakistan2025-04-10 有效
末端脫氧核苷酸轉(zhuǎn)移酶（TdT）抗體試劑（流式細(xì)胞儀法）國(guó)械備20250085號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42，2600 Glostrup，DENMARK2025-04-10 有效
脊柱外科手術(shù)工具國(guó)械備20250084號(hào)Medtronic   Sofamor Danek USA, Inc.4340   Swinnea Road Memphis, TN USA 381182025-04-09 有效
末端脫氧核苷酸轉(zhuǎn)移酶（TdT）抗體試劑（流式細(xì)胞儀法）國(guó)械備20250083號(hào)Agilent   Technologies Singapore (International) Pte.Ltd.Produktionsvej   42, 2600 Glostrup DENMARK2025-04-09 有效
末端脫氧核苷酸轉(zhuǎn)移酶（TdT）抗體試劑（流式細(xì)胞儀法）國(guó)械備20250082號(hào)Agilent   Technologies Singapore (International) Pte.Ltd.Produktionsvej   42, 2600 Glostrup DENMARK2025-04-09 有效
耳鼻喉用開口器國(guó)械備20250081號(hào)FENTEXmedical   GmbHtake-off   Gewerbepark 2 78579 Neuhausen Ob Eck Germany2025-04-09 有效
影像板國(guó)械備20250080號(hào)DüRR   DENTAL SEH?pfigheimer   Str.17,74321 Bietigheim-Bissingen,Germany2025-04-07 有效
品紅染色液國(guó)械備20250079號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, 2600 Glostrup, DENMARK 2025-04-03 有效
p16抗體試劑（免疫組織化學(xué)法）國(guó)械備20250078號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, 2600 Glostrup, DENMARK 2025-04-02 有效
醫(yī)用檢查手套國(guó)械備20250077號(hào)A   R MEDICOM (M) SDN. BHD.189,   Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160, THAILAND; 67/1 M.4 Bypass   Road T.Nongmaidaeng, Amphur Muang, Chonburi 20000 THAILAND2025-04-01 有效

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