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嘉峪檢測(cè)網(wǎng) 2025-09-10 19:14
2025年8月122款進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息
| 序號(hào) | 產(chǎn)品名稱(chēng) | 備案號(hào) | 備案人名稱(chēng)原文 | 生產(chǎn)地址原文 | 備案日期 | 狀態(tài) |
| 1 | 耳鏡 | 國(guó)械備20200119號(hào) | 精國(guó)醫(yī)療器材有限公司 | 新北市蘆洲區(qū)國(guó)道路二段68號(hào)2樓 | 2025-08-29 | 變更 |
| 2 | 醫(yī)用放大鏡 | 國(guó)械備20240380號(hào) | Bryant Medical Ltd t/a Bryant Dental | The Barns, Hilltop Farm, Lyne Lane, Chertsey, KT16 0AW, Surrey, United Kingdom | 2025-08-28 | 變更 |
| 3 | 醫(yī)用高分子夾板 | 國(guó)械備20181577號(hào) | OKM QUIMICA ORTOPEDICA,S.L. | CTRA.,N-260,KM.41,POL.IND.LA TIMBA, NAVE 1,17742 AVINYONET DE PUIGVENTOS (GERONA) | 2025-08-28 | 變更 |
| 4 | CD45抗體試劑 | 國(guó)械備20250307號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 5 | 人類(lèi)白細(xì)胞抗原DR抗體試劑 | 國(guó)械備20250306號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 6 | CD8抗體試劑 | 國(guó)械備20250305號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 7 | CD13抗體試劑 | 國(guó)械備20250304號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 8 | CD33抗體試劑 | 國(guó)械備20250303號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 9 | 髓過(guò)氧化物酶（MPO）抗體試劑 | 國(guó)械備20250302號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 10 | CD4抗體試劑 | 國(guó)械備20250301號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 11 | CD117抗體試劑 | 國(guó)械備20250300號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 12 | CD79a抗體試劑 | 國(guó)械備20250299號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 13 | CD56抗體試劑 | 國(guó)械備20250298號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 14 | CD123抗體試劑 | 國(guó)械備20250297號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 15 | CD4抗體試劑 | 國(guó)械備20250296號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 16 | CD5抗體試劑 | 國(guó)械備20250295號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 17 | CD4抗體試劑 | 國(guó)械備20250294號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 18 | CD5抗體試劑 | 國(guó)械備20250293號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 19 | CD38抗體試劑 | 國(guó)械備20250292號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 20 | CD13抗體試劑 | 國(guó)械備20250291號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 21 | CD45抗體試劑 | 國(guó)械備20250290號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 22 | CD33抗體試劑 | 國(guó)械備20250289號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 23 | CD3抗體試劑 | 國(guó)械備20250288號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 24 | CD79a抗體試劑 | 國(guó)械備20250287號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 25 | CD3抗體試劑 | 國(guó)械備20250286號(hào) | Sysmex Partec GmbH | Nad Safinou II 341, 252 50 Vestec, Czech Republic | 2025-08-28 | 有效 |
| 26 | 醫(yī)用固定帶 | 國(guó)械備20190635號(hào) | 達(dá)豫醫(yī)療器材股份有限公司 | 彰化縣田中鎮(zhèn)新工三路123號(hào) | 2025-08-27 | 變更 |
| 27 | 染色機(jī) | 國(guó)械備20140016號(hào) | Leica Biosystems Melbourne Pty Ltd | 495 Blackburn Road Mt Waverley Victoria 3149 Australia | 2025-08-22 | 變更 |
| 28 | 染色機(jī) | 國(guó)械備20140277號(hào) | Leica Biosystems Melbourne Pty Ltd | 495 Blackburn Road Mt Waverley Victoria 3149 Australia | 2025-08-22 | 變更 |
| 29 | 成形片夾 | 國(guó)械備20250285號(hào) | POLYDENTIA SA | Via Cantonale, 47-CH 6805 Mezzovico-Vira(Svizzera) | 2025-08-22 | 有效 |
| 30 | 牙科成形片器械包 | 國(guó)械備20250284號(hào) | POLYDENTIA SA | Via Cantonale,47-CH6805 Mezzovico-Vira(Svizzera) | 2025-08-22 | 有效 |
| 31 | 牙科隔離及賦形材料器械包 | 國(guó)械備20250283號(hào) | POLYDENTIA SA | Via Cantonale, 47-CH 6805 Mezzovico-Vira(Svizzera) | 2025-08-22 | 有效 |
| 32 | 基礎(chǔ)外科手術(shù)器械 | 國(guó)械備20250282號(hào) | Next Instruments | 410/E, Khadim Ali Road, Sialkot-51310-Pakistan | 2025-08-21 | 有效 |
| 33 | 基礎(chǔ)外科手術(shù)器械 | 國(guó)械備20250281號(hào) | MODERN SURGICAL CORPORATION | Tarrar Street, Mohallah Umer Town, Defence Road, Sialkot, Pakistan | 2025-08-21 | 有效 |
| 34 | 口腔治療器具 | 國(guó)械備20250280號(hào) | LB INSTRUMENTS PVT (LTD.) | 10 KM Daska Road, Near City Housing, Sialkot, Pakistan, 51410 | 2025-08-21 | 有效 |
| 35 | 緩沖液 | 國(guó)械備20250279號(hào) | Siemens Healthcare Diagnostics Products GmbH | Emil von Behring Str.76 35041 Marburg Germany | 2025-08-21 | 有效 |
| 36 | 六胺銀染色液 | 國(guó)械備20161977號(hào) | Ventana Medical Systems, Inc. | 1910E.Innovation Park Drive Tucson, AZ 85755 USA | 2025-08-21 | 變更 |
| 37 | HMB-45抗體試劑（免疫組織化學(xué)） | 國(guó)械備20180600號(hào) | Ventana Medical Systems, Inc. | 1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA | 2025-08-21 | 變更 |
| 38 | MART-1/melan A抗體試劑（免疫組織化學(xué)） | 國(guó)械備20180595號(hào) | Ventana Medical Systems, Inc. | 1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA | 2025-08-21 | 變更 |
| 39 | 過(guò)碘酸雪夫染色液（糖原染色液，PAS） | 國(guó)械備20250170號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2025-08-21 | 變更 |
| 40 | p63抗體試劑（免疫組織化學(xué)） | 國(guó)械備20190039號(hào) | Ventana Medical Systems, Inc. | 1910E.Innovation Park Drive Tucson,Arizona 85755 USA | 2025-08-21 | 變更 |
| 41 | p120抗體試劑（免疫組織化學(xué)） | 國(guó)械備20180248號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson, AZ, 85755, United States | 2025-08-21 | 變更 |
| 42 | 血型分析用稀釋液 | 國(guó)械備20250278號(hào) | Ortho-Clinical Diagnostics | 1001 US Highway 202, Raritan NJ 08869, USA | 2025-08-21 | 有效 |
| 43 | p40抗體試劑（免疫組織化學(xué)） | 國(guó)械備20240237號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2025-08-21 | 變更 |
| 44 | 胰島素瘤相關(guān)蛋白1（INSM1）抗體試劑（免疫組織化學(xué)法） | 國(guó)械備20250277號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2025-08-21 | 有效 |
| 45 | Calretinin抗體試劑（免疫組織化學(xué)） | 國(guó)械備20180435號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson, AZ, 85755, United States | 2025-08-21 | 變更 |
| 46 | 螺絲起 | 國(guó)械備20250276號(hào) | Hiossen, Inc. | 85 Ben Fairless Drive, Fairless Hills, PA, 19030, USA | 2025-08-20 | 有效 |
| 47 | 醫(yī)用檢查手套 | 國(guó)械備20190299號(hào) | A R MEDICOM (M) SDN BHD | 3RD FLOOR, WISMA KOON HOE, NO.3 JALAN 13/3, 46200 PETALING JAYA, SELANGOR DARUL EHSAN, MALAYSIA | 2025-08-19 | 變更 |
| 48 | 醫(yī)用檢查手套 | 國(guó)械備20181202號(hào) | A R Medicom (M) Sdn Bhd | Suite 807, Block A, Kelana Centre Point, 3, Jalan SS7/19, 47301 Petaling Jaya, Selangor, MALAYSIA | 2025-08-19 | 變更 |
| 49 | 種植體安裝輔助器械 | 國(guó)械備20250275號(hào) | radix Implants & Biomaterials GmbH | Hirzenrott 2-4 52076 Aachen Germany | 2025-08-19 | 有效 |
| 50 | 醫(yī)用檢查手套 | 國(guó)械備20200132號(hào) | Mexpo International Inc. | Lot 4969,Jalan Teratai, Batu 6, Off Jalan Meru,41050 Klang, Selangor Darul Ehsan, Malaysia | 2025-08-19 | 變更 |
| 51 | 印模帽 | 國(guó)械備20250274號(hào) | Dentium Co., Ltd. | ??? ??? ??? ????256?? 76, 3F, 4F??, 6F(???) | 2025-08-19 | 有效 |
| 52 | 醫(yī)用超聲波清洗器 | 國(guó)械備20250233號(hào) | Getinge Disinfection AB | Ljungadalsgatan 11, 352 46 Växjö, SWEDEN | 2025-08-19 | 變更 |
| 53 | MUM1抗體試劑 | 國(guó)械備20250273號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 54 | 膠質(zhì)纖維酸性蛋白（GFAP）抗體試劑 | 國(guó)械備20250272號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 55 | 細(xì)胞角蛋白7（CK7）抗體試劑 | 國(guó)械備20250271號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 56 | 黏蛋白4（MUC-4）抗體試劑 | 國(guó)械備20250270號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 57 | 細(xì)胞角蛋白19（CK19）抗體試劑 | 國(guó)械備20250269號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 58 | 雄激素受體（AR）抗體試劑 | 國(guó)械備20250268號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 59 | CD31抗體試劑 | 國(guó)械備20250267號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-19 | 有效 |
| 60 | 牙科修整用不銹鋼車(chē)針 | 國(guó)械備20250266號(hào) | マニー株式會(huì)社 | 栃木県塩谷郡高根沢町中阿久津743；Vang Residential Group，Tan Huong Ward，Pho Yen City，Thai Nguyen Province，Vietnam | 2025-08-18 | 有效 |
| 61 | 樣本稀釋液 | 國(guó)械備20191036號(hào) | Hologic, Inc. | Oaks Business Park Crewe Road, Wythenshawe Manchester M23 9HZ UNITED KINGDOM | 2025-08-18 | 變更 |
| 62 | 病理石蠟包埋機(jī) | 國(guó)械備20171072號(hào) | Hologic, Inc. | 445 Simarano Drive, Marlborough, MA 01752, USA | 2025-08-18 | 變更 |
| 63 | 樣本萃取液 | 國(guó)械備20191035號(hào) | Hologic, Inc. | 10210 Genetic Center Drive, San Diego, CA 92121 UNITED STATES | 2025-08-18 | 變更 |
| 64 | 牽開(kāi)器 | 國(guó)械備20191068號(hào) | ASANUS Medizintechnik GmbH | take off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany | 2025-08-18 | 變更 |
| 65 | H3K27M抗體試劑 | 國(guó)械備20250265號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-18 | 有效 |
| 66 | 生長(zhǎng)激素因子-1（PIT-1）抗體試劑 | 國(guó)械備20250264號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-18 | 有效 |
| 67 | H3K36M抗體試劑 | 國(guó)械備20250263號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-18 | 有效 |
| 68 | Uroplakin Ⅱ抗體試劑 | 國(guó)械備20250262號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-18 | 有效 |
| 69 | 睪丸核蛋白（NUT）抗體試劑 | 國(guó)械備20250261號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-18 | 有效 |
| 70 | H3.3G34W抗體試劑 | 國(guó)械備20250260號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-18 | 有效 |
| 71 | 牙科種植手術(shù)器械包 | 國(guó)械備20250259號(hào) | FIMS Co., Ltd. | ????, ??? ??? ??? ???? 256??76, 4F?? | 2025-08-18 | 有效 |
| 72 | CD3抗體試劑 | 國(guó)械備20250258號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA | 2025-08-15 | 有效 |
| 73 | 漏斗胸手術(shù)器械包 | 國(guó)械備20250257號(hào) | Biomet Microfixation | 1520 Tradeport Drive Jacksonville Florida 32218 USA； 56 East Bell Drive, P.O.Box 587 Warsaw Indiana USA 46581 | 2025-08-15 | 有效 |
| 74 | 咬合紙 | 國(guó)械備20250256號(hào) | Directa AB | Finvids väg 8, SE-194 47 Upplands Väsby, Sweden | 2025-08-15 | 有效 |
| 75 | 超聲探頭穿刺架 | 國(guó)械備20180422號(hào) | CIVCO Medical Instruments Co.,Inc. | 102 FIRST ST.SOUTH Kalona, IA USA 52247 | 2025-08-15 | 變更 |
| 76 | 超聲探頭穿刺架 | 國(guó)械備20180216號(hào) | CIVCO Medical Instruments Co.,Inc. | 102 FIRST ST.SOUTH Kalona, IA USA 52247 | 2025-08-15 | 變更 |
| 77 | 超聲探頭穿刺架 | 國(guó)械備20181495號(hào) | CIVCO Medical Instruments Co., Inc. | 102 FIRST ST. SOUTH, Kalona, IA USA 52247 | 2025-08-15 | 變更 |
| 78 | 醫(yī)用清洗器 | 國(guó)械備20181353號(hào) | CIVCO Medical Instruments Co., Inc. | 102 FIRST ST. SOUTH Kalona, IA USA 52247 | 2025-08-15 | 變更 |
| 79 | 超聲探頭穿刺架 | 國(guó)械備20180055號(hào) | CIVCO Medical Instruments Co.,Inc. | 102 FIRST ST.SOUTH Kalona, IA USA 52247 | 2025-08-15 | 變更 |
| 80 | 染色機(jī) | 國(guó)械備20160156號(hào) | Hologic，Inc. | 250 Campus Drive Marlborough Massachusetts 01752 USA/1750a Costner Dr.Warrington,PA 18976 USA | 2025-08-13 | 變更 |
| 81 | 全自動(dòng)樣本處理及孵育系統(tǒng) | 國(guó)械備20160837號(hào) | Hologic,Inc. | 16990 Goldentop Road, San Diego, CA 92127, United States | 2025-08-13 | 變更 |
| 82 | 一次性使用細(xì)胞過(guò)濾采集器 | 國(guó)械備20160620號(hào) | Hologic, Inc. | 250 Campus Drive, Marlborough, Massachusetts, 01752, USA; 4 Navigator Road, Londonderry, New Hampshire 03053, USA | 2025-08-13 | 變更 |
| 83 | 牙用測(cè)力計(jì) | 國(guó)械備20250255號(hào) | Kube Innovation Inc. | 5524 rue Saint-Patrick, Suite 315 Montréal, Quebec, H4E 1A8, Canada | 2025-08-13 | 有效 |
| 84 | 腹透管路夾 | 國(guó)械備20151519號(hào) | Vantive Health GmbH | Foxford Road, Swinford, CO.Mayo, IRELAND | 2025-08-13 | 變更 |
| 85 | 種植體掃描體 | 國(guó)械備20180660號(hào) | Elos Medtech Pinol A/S | Engvej 33, Gørløse 3330, Denmark | 2025-08-12 | 變更 |
| 86 | 替代體 | 國(guó)械備20181382號(hào) | Elos Medtech Pinol A/S | Engvej 33, Gørløse 3330, Denmark | 2025-08-12 | 變更 |
| 87 | 口腔科手術(shù)器械 | 國(guó)械備20250248號(hào) | LATNED DENTAL | Head,Marala Road, Machikhokhar Sialkot Pakistan. | 2025-08-12 | 變更 |
| 88 | 口外研磨材料 | 國(guó)械備20250254號(hào) | Medifive Co., Ltd. | 324, Korea Industrial Complex, 84, Namdongdong-ro, Namdong-gu, Incheon, Republic of Korea | 2025-08-12 | 有效 |
| 89 | 糞便檢驗(yàn)預(yù)處理裝置 | 國(guó)械備20250253號(hào) | Apacor Limited | Sapphire Centre, Fishponds Road, Wokingham Berkshire RG41 2QL United Kingdom. | 2025-08-12 | 有效 |
| 90 | 口腔科手術(shù)器械 | 國(guó)械備20250252號(hào) | ENGRAVO SURGICO | Azmat Lodge,Moh,Hassan Pura,Gulshan Town,Sialkot,Pakistan | 2025-08-12 | 有效 |
| 91 | 馬鐙形多功能腿架 | 國(guó)械備20160568號(hào) | Herbert（Thailand）Co., Ltd. | 47 Moo 1 Mitraphap Road, Tambon Samran, Amphur Muang, Khon Kaen 40000, Thailand | 2025-08-12 | 變更 |
| 92 | 夾持器 | 國(guó)械備20181256號(hào) | 株式會(huì)社システム?ジェーピー | 靜岡県浜松市東區(qū)下石田町1025番地の1 | 2025-08-12 | 變更 |
| 93 | 馬鐙形多功能腿架 | 國(guó)械備20180217號(hào) | Herbert （Thailand）Co., Ltd | 47 Moo 1 Mitraphap Road，Tambon Samran，Amphur Muang，Khon Kaen 40000，Thailand | 2025-08-12 | 變更 |
| 94 | 馬鐙形多功能腿架 | 國(guó)械備20180218號(hào) | Herbert （Thailand）Co.，Ltd. | 47 Moo 1 Mitraphap Road，Tambon Samran，Amphur Muang，Khon Kaen 40000，Thailand | 2025-08-12 | 變更 |
| 95 | 醫(yī)用射線防護(hù)用具 | 國(guó)械備20210326號(hào) | WSR Medical Solutions LTD | Unit E Bridgewater Close, Network 65 Business Park, Hapton,Burnley, BB11 5TE | 2025-08-12 | 變更 |
| 96 | 負(fù)壓吸引用收集裝置 | 國(guó)械備20190592號(hào) | Medela AG | Lättichstrasse 4b, 6340 Baar, Switzerland | 2025-08-11 | 變更 |
| 97 | 骨傳導(dǎo)植入式聽(tīng)力系統(tǒng)植入手術(shù)器械包 | 國(guó)械備20210449號(hào) | Elos Medtech Pinol A/S | Engvej 33, Gørløse 3330, Denmark | 2025-08-11 | 變更 |
| 98 | 骨傳導(dǎo)植入式聽(tīng)力系統(tǒng)植入手術(shù)器械包 | 國(guó)械備20210423號(hào) | Cochlear Bone Anchored Solutions AB | Konstruktionsvagen 14, SE-435 33 Molnlycke, Sweden | 2025-08-11 | 變更 |
| 99 | 骨傳導(dǎo)植入式聽(tīng)力系統(tǒng)植入手術(shù)器械包 | 國(guó)械備20190728號(hào) | Cochlear Bone Anchored Solutions AB | Konstruktionsvagen 14, SE-435 33 Molnlycke, Sweden | 2025-08-11 | 變更 |
| 100 | 牽開(kāi)器 | 國(guó)械備20250251號(hào) | medical bees GmbH | Friedrich-Wöhler-Straße 13 78576 Emmingen Germany | 2025-08-11 | 有效 |
| 101 | 樣本稀釋液 | 國(guó)械備20250058號(hào) | Roche Diagnostics GmbH | Nonnenwald 2, 82377 Penzberg, GERMANY | 2025-08-11 | 變更 |
| 102 | 醫(yī)用檢查手套 | 國(guó)械備20250250號(hào) | UG GLOBAL RESOURCES SDN. BHD. | Lot 62 & 63, Lorong Senawang 3/2,Kawasan Perindustrian Senawang, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia | 2025-08-11 | 有效 |
| 103 | 醫(yī)用壓敏膠帶 | 國(guó)械備20250249號(hào) | ????? | ??? ??? ??? ??? ???291?? 74 | 2025-08-08 | 有效 |
| 104 | 試模 | 國(guó)械備20140363號(hào) | Smith & Nephew Orthopaedics AG | Schachenallee 29,5001 Aarau, Switzerland; Dammweg 39,5001 Aarau, Switzerland | 2025-08-08 | 變更 |
| 105 | 髖關(guān)節(jié)手術(shù)器械 | 國(guó)械備20161805號(hào) | Smith & Nephew Orthopaedics AG |
Schachenalle 29,5001 Aarau, Switzerland; Dammweg 39,5001 Aarau, Switzerland; Oberneuhofstrasse 10a, 6340 Baar, Switzerland; Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C.22444, Mexico. Ul.Stanislawa Staszica 555-011 Siechnice Polen; Grünauer Fenn 3, 14712 Rathenow, Germany |
2025-08-07 | 變更 |
| 106 | 干式激光成像儀 | 國(guó)械備20151260號(hào) | コニカミノルタ株式會(huì)社 | 埼玉県狹山市広瀬臺(tái)二丁目2番1號(hào) 2-2-1， Hirosedai，Sayama-shi，Saitama | 2025-08-07 | 變更 |
| 107 | 醫(yī)用體位膠墊 | 國(guó)械備20140329號(hào) | ???? ???? ???? | 無(wú) | 2025-08-07 | 無(wú)效 |
| 108 | 壓力繃帶 | 國(guó)械備20180201號(hào) | Medi GmbH & Co.KG | Medicusstraβe 1, 95448 Bayreuth, Germany | 2025-08-07 | 變更 |
| 109 | 干式激光成像儀 | 國(guó)械備20170398號(hào) | コニカミノルタ株式會(huì)社 | 1 Sakura-machi，Hino-shi，Tokyo，Japan；2-2-1， Hirosedai，Sayama-shi，Saitama，Japan | 2025-08-06 | 變更 |
| 110 | 口腔科手術(shù)器械 | 國(guó)械備20250248號(hào) | LATNED DENTAL | Head,Marala Road, Machikhokhar Sialkot Pakistan. | 2025-08-05 | 有效 |
| 111 | 醫(yī)用外固定支具 | 國(guó)械備20170130號(hào) | THUASNE | 118/120, rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET; 4615 Shepard St. Bakersfield, CA 93313;Im Steinkamp 12, 30938 Burgwedel | 2025-08-05 | 變更 |
| 112 | 彈性繃帶 | 國(guó)械備20171074號(hào) | CIZETA MEDICALI S.P.A. | Via IV Novembre,46-20012 CUGGIONO(MI)-ITALY | 2025-08-04 | 變更 |
| 113 | 口腔科器械 | 國(guó)械備20240396號(hào) | A.Schweickhardt GmbH＆Co.KG | Tuttlinger Straβe 12 78606 Seitingen-Oberflacht Germany | 2025-08-04 | 變更 |
| 114 | 牙科骨磨 | 國(guó)械備20230091號(hào) | A.Schweickhardt GmbH & Co.KG | Tuttlinger Straße 12 78606 Seitingen/ Tuttlingen Germany | 2025-08-04 | 變更 |
| 115 | 口腔科器械 | 國(guó)械備20191336號(hào) | A.Schweickhardt GmbH＆Co.KG | Tuttlinger Straße 12 78606 Seitingen / Tuttlingen Germany | 2025-08-04 | 變更 |
| 116 | 骨鉸刀 | 國(guó)械備20250247號(hào) | Gebr. Brasseler GmbH & Co. KG | Trophagener Weg 25 32657 Lemgo Germany | 2025-08-04 | 有效 |
| 117 | 自動(dòng)制片機(jī) | 國(guó)械備20151734號(hào) | Hologic，Inc. | 445 Simarano Drive, Marlborough, MA 01752 USA | 2025-08-04 | 變更 |
| 118 | 清洗液 | 國(guó)械備20191034號(hào) | Hologic, Inc. | 10210 Genetic Center Drive, San Diego, CA 92121 UNITED STATES | 2025-08-04 | 變更 |
| 119 | 半月板縫合修復(fù)手術(shù)器械（包） | 國(guó)械備20250246號(hào) | ConMed Corporation | 11311 Concept Boulevard, Largo, FL 33773, USA | 2025-08-04 | 有效 |
| 120 | 液基薄層細(xì)胞制片機(jī) | 國(guó)械備20151732號(hào) | Hologic,Inc. | 445 Simarano Drive, Marlborough, MA 01752 USA | 2025-08-04 | 變更 |
| 121 | 磷酸鹽緩沖液 | 國(guó)械備20250245號(hào) | Miltenyi Biotec B.V. & Co. KG | Robert-Koch-Strasse 1, 17166 Teterow, GERMANY | 2025-08-01 | 有效 |
| 122 | 手術(shù)頭架 | 國(guó)械備20170083號(hào) | Herbert（Thailand）Co., Ltd. | 47 Moo 1 Mitraphap Road, Tambon Samran, Amphur Muang, Khon Kaen 40000, Thailand | 2025-08-12 | 無(wú)效 |
來(lái)源：國(guó)家藥品監(jiān)督管理局
