| 序號(hào) | 醫(yī)療器械產(chǎn)品名稱 | 醫(yī)療器械備案號(hào) | 備案人名稱原文 | 生產(chǎn)地址原文 |
| 1 | 橡皮障 | 國械備20220240號(hào) | Dent4You AG | Lot 6, Lorong Bemban 2,Bemban Industrial Park, Batu Gajah Perak,31000, Malaysia； 1245 Home Avenue, Akron, Ohio, 44301, United States |
| 2 | 骨水泥槍 | 國械備20220545號(hào) | Tecres S.p.A. | Via Andrea Doria, 6 Sommacampagna (VR) 37066 Italy |
| 3 | 手術(shù)用頭架 | 國械備20150066號(hào) | Integra LifeSciences Corporation | 4900 Charlemar Dr. Building A, Cincinnati, OH 45227 USA |
| 4 | 顱骨鉆 | 國械備20240155號(hào) | Brainlab SE | Olof-Palme-Stra?e 9, 81829 München,Germany |
| 5 | 導(dǎo)航手術(shù)工具 | 國械備20200654號(hào) | Brainlab SE | Olof-Palme-Stra?e 9, 81829 München,Germany |
| 6 | 增強(qiáng)液 | 國械備20200322號(hào) | DiaSorin Italia S.p.A. | Von-Hevesy-Str. 3, 63128 Dietzenbach, Germany |
| 7 | 胸腔組織鉗 | 國械備20151160號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 8 | 二尖瓣膜拉鉤 | 國械備20151161號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 9 | 胸腔止血鉗 | 國械備20151162號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 10 | 基礎(chǔ)外科手術(shù)器械 | 國械備20151337號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 11 | 咬骨鉗 | 國械備20151165號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 12 | 心臟手術(shù)剪 | 國械備20151164號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 13 | 肋骨合攏器 | 國械備20151152號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 14 | 二尖瓣膜拉鉤 | 國械備20151153號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 15 | 胸腔鑷 | 國械備20151159號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 16 | 骨用牽開器 | 國械備20151146號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 17 | 頸椎牽開器 | 國械備20151148號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 18 | 腹部手術(shù)牽開器 | 國械備20151151號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 19 | 骨科撐開器 | 國械備20151144號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 20 | 倒置生物顯微鏡 | 國械備20250071號(hào) | NIKON CORPORATION | 471, NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN |
| 21 | 倒置生物顯微鏡 | 國械備20230515號(hào) | 株式會(huì)社二コン | 471, Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan |
| 22 | 生物顯微鏡 | 國械備20240266號(hào) | NIKON CORPORATION | 471, NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN |
| 23 | 生物顯微鏡 | 國械備20220063號(hào) | 株式會(huì)社二コン | 244-8533 日本神奈川県橫浜市栄區(qū)長尾臺(tái)町471 |
| 24 | 口腔觀察儀 | 國械備20250476號(hào) | Dentall Co., Ltd. | 301-905, Bucheon Technopark, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501, Republic of Korea |
| 25 | 全自動(dòng)核酸提取純化儀 | 國械備20181731號(hào) | Tecan Schweiz AG | Seestraβe 103, 8708 M?nnedorf, Switzerland |
| 26 | 全自動(dòng)核酸提取純化儀 | 國械備20160221號(hào) | Tecan Schweiz AG | Seestraβe 103, CH-8708 Mannedorf, Switzerland |
| 27 | 雙目放大鏡 | 國械備20250475號(hào) | ExamVision A/S | Industrivej 11, 8305 Samsφ, Denmark |
| 28 | 正畸鉗 | 國械備20170044號(hào) | WORLD BIO TECH CO., LTD. | BizCenter-302,(Sangdaewon-dong, SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do |
| 29 | 打磨拋光組件 | 國械備20170041號(hào) | WORLD BIO TECH CO., LTD. | BizCenter-302,(Sangdaewon-dong, SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do |
| 30 | 義齒修復(fù)工具 | 國械備20161964號(hào) | Zest Anchors, LLC | 2230 Enterprise Street, Escondido, California, 92029, USA |
| 31 | 骨科外固定夾板 | 國械備20181768號(hào) | THUASNE | 118/120, rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET |
| 32 | 基礎(chǔ)外科手術(shù)器械 | 國械備20250474號(hào) | EKAL SURGICAL WORKS | Kashmir Road, Ismailabad, Pacca Garha, Sialkot - 51310 - Pakistan |
| 33 | 口腔治療器具 | 國械備20250473號(hào) | EKAL SURGICAL WORKS | Kashmir Road, Ismailabad, Pacca Garha, Sialkot - 51310 - Pakistan |
| 34 | 口腔治療器具 | 國械備20250472號(hào) | BILLU BROTHERS SURGICAL CO. | JEEWAN PURA, SIALKOT-51310, PAKISTAN |
| 35 | 口腔治療器具 | 國械備20250471號(hào) | SOBYTEK (PRIVATE) LIMITED | Roras Road, Muzaffar Pur, Sialkot 51310 – Pakistan |
| 36 | 基礎(chǔ)外科手術(shù)器械 | 國械備20250470號(hào) | J.R. BROTHERS SURGICAL INSTRUMENTS Incorporating the NOMI INDUSTRIES Brand | P.O. Box 1195 Near Peer Hara, Harrar, Sialkot Pakistan |
| 37 | 牙科角度尺 | 國械備20250469號(hào) | Ivoclar Vivadent AG | Bendererstrasse 2, 9494 Schaan, LIECHTENSTEIN；Bremschlstrasse 16, 6706 Bürs, AUSTRIA |
| 38 | Kappa鏈抗體試劑（免疫組織化學(xué)） | 國械備20180643號(hào) | Ventana Medical Systems, Inc. | 1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA |
| 39 | 過碘酸雪夫染色液（糖原染色液，PAS） | 國械備20250170號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA |
| 40 | 顯微外科手術(shù)器械 | 國械備20151338號(hào) | Best medical GmbH | Heudorferstrasse 32 D-78576 Emmingen-Liptingen |
| 41 | 去血片洗板機(jī) | 國械備20200542號(hào) | Wallac Oy | 7 rue de Madrid , 67300 SCHILTIGHEIM, FRANCE |
| 42 | 一次性使用唾液采集器 | 國械備20230045號(hào) | DNA Genotek Inc. | 3000 - 500 Palladium Drive; Ottawa, ON; K2V1C2 CANADA |
| 43 | 牙科種植體通用取出工具包 | 國械備20250468號(hào) | Neobiotech Co., Ltd. | 70, Sinpyeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Republic of Korea |
| 44 | 牙科拋光磨頭 | 國械備20250467號(hào) | EVE Ernst Vetter GmbH | Neureutstra?e 6 75210 Keltern Germany |
| 45 | 樣本稀釋液 | 國械備20200454號(hào) | The Binding Site Group Ltd | 8 Calthorpe Road Edgbaston Birmingham B15 1QT United Kingdom |
| 46 | 檢查手套 | 國械備20170721號(hào) | Medline Industries, LP | PTD 3274 BATU 4 1/2 JALAN BAKRI MURA, Johor MALAYSIA 84000
LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDER BARU SALAK TINGGI, SEPANG, Selangor MALAYSIA 43900
PLOT4, KAW. PERINDUSTRIANTANJUNG KLING, TANJUNG BRUAS JETIMELAKA, Melaka MALAYSIA 76400
|
| 47 | 檢查手套 | 國械備20170722號(hào) | Medline Industries, LP | No.7, Kawasan Perusahaan Suria,Bestari Jaya, Selangor MALAYSIA 45600
JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ.MORAWA MEDAN, NORTH SUMATERA, Sumatera Utara INDONESIA 20362
LOT55, NO.15, JALAN JASMIN 2 BUKIT BERUNTUNG, Selangor MALAYSIA 48300
LOT 1422-1424, BATU 10 LEKIR SITIAWAN, Perak MALAYSIA 32020 |
| 48 | 鉆針深度停止器 | 國械備20250466號(hào) | ACH Medical Co., Ltd. | 28, Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea |
| 49 | 拋光工具 | 國械備20190533號(hào) | OOO＂Полировальные системы＂ | Россия, 175400, Новгородская область, г. Валдай, Крестецкий тупик, д.1 |
| 50 | 種植體安裝輔助器械 | 國械備20250465號(hào) | ACH Medical Co., Ltd. | 28, Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea |
| 51 | 種植輔助材料 | 國械備20250464號(hào) | ACH Medical Co., Ltd. | 28, Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea |
| 52 | 正畸鉗 | 國械備20250463號(hào) | Ormco Corporation | 3232 N Rockwell Street Chicago, IL 60618 USA |
| 53 | 樣本稀釋液 | 國械備20161296號(hào) | Instrumentation Laboratory Company | 526 Route 303 Orangeburg NY 10962 United States Of America |
| 54 | 清洗液 | 國械備20161107號(hào) | Instrumentation Laboratory Company | Can Male, s/n 08186 Llica d’Amunt, Barcelona Spain |
| 55 | 激發(fā)液 | 國械備20140129號(hào) | Instrumentation Laboratory Co. | Can Male, 08186 Llica d’Amunt, Barcelona Spain |
| 56 | 腹部造口彈性繃帶 | 國械備20250150號(hào) | Tytex A/S | Chemlonská 1,06601 Humenné, Slovakia |
| 57 | 免疫顯色試劑 | 國械備20181025號(hào) | INOVA Diagnostics, Inc. | 9900 Old Grove Road San Diego California 92131 USA |
| 58 | 一次性糞便蛋白提取裝置 | 國械備20210604號(hào) | INOVA Diagnostics, Inc. | VIA FLAVIA 122 TRIESTE, Trieste ITALY 34147 |
| 59 | 牙用輸送器 | 國械備20191194號(hào) | DXM CO.,Ltd. | No.1003,11santechnotown B1dg.,138,11sandong-gu,Goyang-si,Gyonnggi-do,Korea |
| 60 | 樣本稀釋液 | 國械備20180693號(hào) | Solventum Japan Innovation Limited | 9900 Old Grove Road San Diego California 92131 USA |
| 61 | 蛋白提取試劑 | 國械備20210603號(hào) | DXM Co., Ltd | 9900 Old Grove Road San Diego California 92131 USA |
| 62 | 基礎(chǔ)外科手術(shù)器械 | 國械備20250462號(hào) | ARAMID INDUSTRIES | NOL MOR,WAZIRABAD ROAD SIALKOT-PAKISTAN |
| 63 | 試模 | 國械備20161915號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 64 | 扳手 | 國械備20161908號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 65 | 螺桿夾持鉗 | 國械備20161788號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 66 | 骨科用螺絲刀 | 國械備20161927號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 67 | 打入器 | 國械備20161909號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 68 | 髖關(guān)節(jié)手術(shù)工具包 | 國械備20190200號(hào) | JRI ORTHOPAEDICS LTD | 18 Churchill Way, 35A Business Park， Chapeltown, Sheffield S35 2PY, UK |
| 69 | 快裝手柄 | 國械備20161916號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 70 | 量規(guī) | 國械備20161913號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 71 | 拔出器 | 國械備20161917號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 72 | 骨科鉆孔瞄準(zhǔn)器 | 國械備20161928號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 73 | 骨用牽開器 | 國械備20161912號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 74 | 骨鉸刀 | 國械備20161914號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 75 | 骨銼 | 國械備20161926號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 76 | 骨銼 | 國械備20150067號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 77 | 骨鉤 | 國械備20161910號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 78 | 持骨鉗 | 國械備20161787號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 79 | 骨鉆 | 國械備20161925號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 80 | 骨刮匙 | 國械備20161911號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 81 | 骨鑿 | 國械備20161924號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park,Chapeltown, Sheffield, S35 2PY |
| 82 | 骨錐 | 國械備20170210號(hào) | JRI ORTHOPAEDICS LIMITED | 18 Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY |
| 83 | 牙科種植掃描定位件 | 國械備20181322號(hào) | Anthogyr SAS | 2237 avenue André Lasquin, 74700 SALLANCHES FRANCE |
| 84 | 清洗液 | 國械備20151638號(hào) | Roche Diagnostics GmbH | Sandhofer Strasse 116, 68305 Mannheim,Germany |
| 85 | 醫(yī)用退熱貼 | 國械備20151768號(hào) | Solventum US LLC | 601 22nd Ave. South Brookings, South Dakota, 57006, USA |
| 86 | 琥珀酸脫氫酶復(fù)合體B亞基（SDHB）抗體試劑（免疫組織化學(xué)） | 國械備20250461號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 87 | 胰島蛋白（Langerin）抗體試劑（免疫組織化學(xué)） | 國械備20250460號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 88 | CD123抗體試劑（免疫組織化學(xué)） | 國械備20250459號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 89 | 癌胚抗原（CEA）抗體試劑（免疫組織化學(xué)） | 國械備20250458號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 90 | LMO2抗體試劑（免疫組織化學(xué)） | 國械備20250457號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 91 | CD5抗體試劑（免疫組織化學(xué)） | 國械備20250456號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 92 | 乙型肝炎病毒表面抗原（HBsAg） 抗體試劑（免疫組織化學(xué)） | 國械備20250455號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 93 | 細(xì)胞周期蛋白依賴性激酶4（CDK4）抗體試劑（免疫組織化學(xué)） | 國械備20250454號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 94 | CD21抗體試劑（免疫組織化學(xué)） | 國械備20250453號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 95 | 乙型肝炎核心抗原（HBcAg）抗體試劑（免疫組織化學(xué)） | 國械備20250452號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 96 | 蛋白基因產(chǎn)物9.5（Protein Gene Product9.5）抗體試劑（免疫組織化學(xué)） | 國械備20250451號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 97 | 腺病毒（Adenovirus）抗體試劑（免疫組織化學(xué)） | 國械備20250450號(hào) | Cell Marque Corporation | 6600 Sierra College Blvd. Rocklin, CA 95677 USA |
| 98 | 基礎(chǔ)外科手術(shù)器械 | 國械備20210455號(hào) | Cardio Surgical Ltd. | Clogan, Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland |
| 99 | 神經(jīng)和心血管手術(shù)器械 | 國械備20210436號(hào) | Cardio Surgical Ltd. | Clogan, Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland |
| 100 | 骨科手術(shù)器械 | 國械備20210435號(hào) | Cardio Surgical Ltd. | Clogan, Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland |
| 101 | 研光器 | 國械備20170116號(hào) | Kerr Italia S.r.l. | Via Strecce 4 P.O. 272 6934 Bioggio Switzerland |
| 102 | 口腔科器械 | 國械備20240294號(hào) | Exlin(Pvt)Ltd | Nasir Road, Near Classico Chowk, Sialkot-51310 - Pakistan |
| 103 | 運(yùn)送培養(yǎng)基 | 國械備20210229號(hào) | Copan Italia S.p.A. | Via F. Perotti 18，25125 Brescia，Italy；Via F. Perotti 10，25125 Brescia，Italy |
| 104 | 運(yùn)送培養(yǎng)基 | 國械備20191277號(hào) | Copan Italia S.p.A. | Via F. Perotti 18, 25125 Brescia, Italy; Via F. Perotti 10, 25125 Brescia, Italy |
| 105 | 一次性使用細(xì)胞過濾采集器 | 國械備20160622號(hào) | Hologic，Inc. | 250 Campus Drive, Marlborough, Massachusetts, 01752, USA |
| 106 | 細(xì)胞保存液 | 國械備20160550號(hào) | Hologic, Inc. | 250 Campus Drive, Marlborough, Massachusetts, 01752, USA |
| 107 | 巴氏染色液 | 國械備20150010號(hào) | Hologic, Inc. | 250 Campus Drive, Marlborough, Massachusetts, 01752，USA |
| 108 | 細(xì)胞保存液 | 國械備20140197號(hào) | Hologic, Inc. |
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| 109 | 一次性使用細(xì)胞過濾采集器 | 國械備20160621號(hào) | Hologic,Inc. | 250 Campus Drive, Marlborough, Massachusetts, 01752, USA; 4 Navigator Road, Londonderry, New Hampshire 03053, USA |
| 110 | 細(xì)胞保存液 | 國械備20140367號(hào) | Hologic, Inc. |
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| 111 | 細(xì)胞清洗液 | 國械備20140214號(hào) | Hologic, Inc. | 250 Campus Drive, Marlborough, Massachusetts, 01752，USA |
| 112 | 顯微持針鑷 | 國械備20250449號(hào) | MED-EL Elektromedizinische Ger?te GmbH | Fürstenweg 77A 6020 Innsbruck AUSTRIA |
| 113 | 自動(dòng)加樣系統(tǒng) | 國械備20240131號(hào) | Becton, Dickinson and Company, BD Biosciences | Neuwiesenstrasse 4, 8222 Beringen, Switzerland |
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