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嘉峪檢測(cè)網(wǎng) 2023-05-12 09:51
近日，國家藥品監(jiān)督管理局發(fā)布《2023年4月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，內(nèi)容如下：
| 2023年4月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息 | ||||||
| 序號(hào) | 產(chǎn)品名稱 | 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) |
| 1 | 全自動(dòng)免疫檢驗(yàn)系統(tǒng)用終止液 | 國械備20160411號(hào) | Phadia AB | Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala | 2023-04-28 | 變更 |
| 2 | 樣本稀釋液 | 國械備20160409號(hào) | Phadia AB | Rapsgatan 7P, P.O.Box 6460, 751 37 Uppsala | 2023-04-28 | 變更 |
| 3 | 清洗液 | 國械備20160410號(hào) | Phadia AB | Rapsgatan 7P, P. O. Box 6460, 751 37 Uppsala | 2023-04-28 | 變更 |
| 4 | 扭力扳手 | 國械備20230257號(hào) | ???? ???? | ???? ??? ?????4? 23-3 | 2023-04-28 | 有效 |
| 5 | 血細(xì)胞分析用溶血?jiǎng)?/span> | 國械備20230256號(hào) | シスメックス株式會(huì)社 | 兵庫県小野市匠臺(tái)17番地 | 2023-04-28 | 有效 |
| 6 | 血細(xì)胞分析用染色液 | 國械備20230255號(hào) | シスメックス株式會(huì)社 | 兵庫県小野市匠臺(tái)17番地 | 2023-04-28 | 有效 |
| 7 | 醫(yī)用檢查手套 | 國械備20230254號(hào) | Koon Seng Sdn.Bhd. | PTD 16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia | 2023-04-27 | 有效 |
| 8 | 醫(yī)用檢查手套 | 國械備20230253號(hào) | Koon Seng Sdn.Bhd. | PTD 16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia | 2023-04-27 | 有效 |
| 9 | 脊柱外科手術(shù)器械包 | 國械備20161359號(hào) | CM Instrumente GmbH | Gänsäcker 56，78532 Tuttlingen，Germany | 2023-04-27 | 變更 |
| 10 | 綁扎膠布 | 國械備20170250號(hào) | 3M Thailand Limited | 53/1 Soi Sukhapiban 2, Tambol Rahaeng, Amphur, Lardloomkaew, Pathumthani 12140, Thailand | 2023-04-27 | 無效 |
| 11 | 血細(xì)胞分析用染色液 | 國械備20230252號(hào) | シスメックス株式會(huì)社 | 兵庫県小野市匠臺(tái)17番地 | 2023-04-27 | 有效 |
| 12 | 血細(xì)胞分析用稀釋液 | 國械備20230251號(hào) | シスメックス株式會(huì)社 | 兵庫県小野市匠臺(tái)17番地 | 2023-04-27 | 有效 |
| 13 | 鼻骨銼 | 國械備20161945號(hào) | Integra MicroFrance SAS | Le Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstraße 8, 78532 Tuttlingen, GERMANY | 2023-04-27 | 變更 |
| 14 | CD79a檢測(cè)試劑 | 國械備20230250號(hào) | BioLegend, Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-04-26 | 有效 |
| 15 | TNFα檢測(cè)試劑 | 國械備20230249號(hào) | BioLegend, Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-04-26 | 有效 |
| 16 | CD79a檢測(cè)試劑 | 國械備20230248號(hào) | BioLegend, Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-04-26 | 有效 |
| 17 | 全自動(dòng)核酸提取純化儀 | 國械備20150040號(hào) | HAMILTON BONADUZ AG | Via Crusch 8 CH-7402 Bonaduz Switzerland | 2023-04-26 | 變更 |
| 18 | AMACR/p504s抗體試劑（免疫組織化學(xué)） | 國械備20181784號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States | 2023-04-25 | 變更 |
| 19 | 鼻組織鉗 | 國械備20161696號(hào) | Integra MicroFrance SAS | Le Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800 Nogent, France; Schloßäckerweg 6/1, 78582 Balgheim, Germany | 2023-04-25 | 變更 |
| 20 | 顯微持針鉗 | 國械備20161942號(hào) | Integra MicroFrance SAS | Le Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE | 2023-04-25 | 變更 |
| 21 | 革蘭染色液 Color Gram 2 (COLOR GRAM 2-F) | 國械備20140221號(hào) | bioMérieux SA | Site de Montesquieu – Bordeaux Technopolis 33650 MARTILLAC France | 2023-04-25 | 變更 |
| 22 | 替代體 | 國械備20161880號(hào) | DENTSPLY Implants Manufacturing GmbH | Aminogatan 1, PO Box 14, 43121 Mölndal，SWEDEN | 2023-04-25 | 變更 |
| 23 | 楔子 | 國械備20181129號(hào) | Polydentia SA | Via Cantonale 47,CH-6805 Mezzovico | 2023-04-25 | 變更 |
| 24 | 打磨拋光組件 | 國械備20170149號(hào) | Hager & Meisinger GmbH | Hansemannstraβe 10, 41468 Neuss Deutschland | 2023-04-25 | 變更 |
| 25 | 上/下肢醫(yī)用外固定支具 | 國械備20230247號(hào) | JC OrthoHeal Private Limited | JC OrthoHeal Private Limited GF-33/34, Classic Towers,Near Akota Garden, Akota,Vadodara, Gujarat-390020，India | 2023-04-25 | 有效 |
| 26 | 放射治療患者用固定裝置 | 國械備20230246號(hào) | Medtec, LLC dba CIVCO Radiotherapy | 1401 8th St. SE, Orange City, IA, 51041, United States | 2023-04-25 | 有效 |
| 27 | 生物顯微鏡 | 國械備20210551號(hào) | 株式會(huì)社エビデント | 長野県上伊那郡辰野町大字伊那富6666番地 | 2023-04-24 | 變更 |
| 28 | 牙科手術(shù)器械包 | 國械備20230245號(hào) | ABRAHAM BLACKSMITH | Abrona Street, Small Industrial Estate, Sialkot-51310-Pakistan | 2023-04-23 | 有效 |
| 29 | 影像板及暗盒 | 國械備20200585號(hào) | PaloDEx Group Oy | Nahkelantie 160, FI-04300 Tuusula, Finland | 2023-04-23 | 變更 |
| 30 | 口腔數(shù)字觀察儀 | 國械備20200629號(hào) | WINUS Technology Co., Ltd | 5F, 298-7, Gongdan-ro, Gunpo-si, Gyeonggi-do, 15809, KOREA | 2023-04-23 | 變更 |
| 31 | 膝關(guān)節(jié)手術(shù)器械包 | 國械備20230244號(hào) | Blue Belt Technologies, Inc. | 76 South Meridian Ave Oklahoma City Oklahoma 73107-6512 USA | 2023-04-21 | 有效 |
| 32 | 股骨髓腔對(duì)線手柄套 | 國械備20152022號(hào) | Waldemar Link GmbH & Co.KG | Barkhausenweg 10 22339 Hamburg GERMANY | 2023-04-21 | 變更 |
| 33 | 骨撬 | 國械備20152018號(hào) | Waldemar Link GmbH & Co.KG | Barkhausenweg 10 22339 Hamburg GERMANY | 2023-04-21 | 變更 |
| 34 | 骨拉鉤 | 國械備20152012號(hào) | Waldemar Link GmbH & Co.KG | Barkhausenweg 10 22339 Hamburg GERMANY | 2023-04-21 | 變更 |
| 35 | 骨錐 | 國械備20152024號(hào) | Waldemar Link GmbH & Co.KG | Barkhausenweg 10 22339 Hamburg GERMANY | 2023-04-21 | 變更 |
| 36 | 測(cè)深器 | 國械備20151879號(hào) | Waldemar Link GmbH & Co.KG | Barkhausenweg 10 22339 Hamburg GERMANY | 2023-04-21 | 變更 |
| 37 | 骨科鉆頭 | 國械備20152029號(hào) | Waldemar Link GmbH & Co.KG |
Barkhausenweg 10 22339 Hamburg GERMANY |
2023-04-21 | 變更 |
| 38 | 骨鉸刀 | 國械備20152028號(hào) | Waldemar Link GmbH & Co.KG |
Barkhausenweg 10 22339 Hamburg GERMANY |
2023-04-21 | 變更 |
| 39 | 牙科種植手術(shù)修復(fù)工具包 | 國械備20230243號(hào) | BEGO Implant Systems GmbH & Co. KG | Wilhelm-Herbst-Str. 1, 28359 Bremen, Germany | 2023-04-20 | 有效 |
| 40 | 快接頭 | 國械備20230242號(hào) | Synthes GmbH | 4500 Riverside Drive, Palm Beach Gardens, FL 33410, USA | 2023-04-20 | 有效 |
| 41 | 醫(yī)用檢查手套 | 國械備20150165號(hào) | Hartalega Sdn. Bhd. | 7, Kawasan Perusahaan Suria, 45600 Bestari Jaya, Selangor Malaysia | 2023-04-20 | 變更 |
| 42 | 手術(shù)剪 | 國械備20230241號(hào) | Georg Alber GmbH | Lindenstrasse 13-78603 Renquishausen Germany | 2023-04-20 | 有效 |
| 43 | 呼吸訓(xùn)練器 | 國械備20160866號(hào) | / | C/ Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain | 2023-04-20 | 變更 |
| 44 | 成形片夾 | 國械備20230240號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 45 | 拔牙鉗 | 國械備20230239號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 46 | 口腔麻醉注射架 | 國械備20230238號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 47 | 口腔止血鉗 | 國械備20230237號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 48 | 上頜竇內(nèi)提升器 | 國械備20230236號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 49 | 牙科器械鉗 | 國械備20230235號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 50 | 基礎(chǔ)外科用鉗 | 國械備20230234號(hào) | FIRST CLASS TRADERS | P.O. Box: 1762, Kingra Road, Lageriali, Sialkot-51310-Pakistan | 2023-04-20 | 有效 |
| 51 | 橡皮障夾鉗 | 國械備20230233號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 52 | 橡皮障支架 | 國械備20230232號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 53 | 橡皮障夾 | 國械備20230231號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 54 | 橡皮障打孔器 | 國械備20230230號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 55 | 牙挺 | 國械備20230229號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 56 | 牙科用鑷 | 國械備20230228號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 57 | 正畸鉗 | 國械備20230227號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 58 | 牙科用剪 | 國械備20230226號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 59 | 牙科用牽開器 | 國械備20230225號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 60 | 牙科去冠器 | 國械備20230224號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-20 | 有效 |
| 61 | 視力表燈箱 | 國械備20230223號(hào) | Good-Lite Company | 1155 Jansen Farm Drive Elgin, IL 60123 | 2023-04-19 | 有效 |
| 62 | CD5抗體試劑（免疫組織化學(xué)） | 國械備20180756號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States | 2023-04-18 | 變更 |
| 63 | 阿利辛藍(lán)－過碘酸雪夫氏染色液 | 國械備20230222號(hào) | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES | 2023-04-18 | 有效 |
| 64 | 吸唾管 | 國械備20160481號(hào) | Henry Schein Inc. | VIA DELL'ARTIGIANATO 7-36030 MONTECCHIO PRECALCINO(VI) ITALY | 2023-04-18 | 變更 |
| 65 | 橡皮障 | 國械備20160823號(hào) | Henry Schein Inc. | No 16, Persiaran Perindustrian Kanthan 1, Kawansan Perindustrian Kanthan, 31200 Chemor, Perak, Malaysia | 2023-04-18 | 變更 |
| 66 | 醫(yī)用檢查手套 | 國械備20220660號(hào) | Henry Schein Inc. | 189, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160, THAILAND | 2023-04-18 | 變更 |
| 67 | 核酸提取或純化試劑 | 國械備20180501號(hào) | BIOMERIEUX S.A. | Centre Christophe Merieux-5 rue des Berges-38024 GRENOBLE CEDEX 01-FRANCE | 2023-04-18 | 變更 |
| 68 | 放射治療患者用固定裝置 | 國械備20140355號(hào) | Medtec, LLC dba CIVCO Radiotherapy | 1401 8th St. SE, Orange City, IA, 51041, United States | 2023-04-18 | 變更 |
| 69 | 放射治療患者用固定裝置 | 國械備20181007號(hào) | Medtec, LLC dba CIVCO Radiotherapy | 1401 8TH ST. S.E. Orange City, IA USA 51041 | 2023-04-18 | 變更 |
| 70 | 正畸自鎖托槽開啟器 | 國械備20230221號(hào) | 3M Unitek Corporation | 3232 N. Rockwell Street, Chicago, IL, 60618, United States | 2023-04-17 | 有效 |
| 71 | 扭力扳手 | 國械備20140364號(hào) | Alpha-Bio Tec Ltd. | 7 Hatnufa St.,Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel | 2023-04-17 | 變更 |
| 72 | 牙用尺 | 國械備20180520號(hào) | Alpha-Bio Tec Ltd | 7 Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel | 2023-04-17 | 變更 |
| 73 | 檢查手套 | 國械備20170549號(hào) | Mexpo International Inc. | 馬來西亞，雪蘭州，巴生，奧夫嘉蘭馬路，巴圖5，嘉蘭特拉泰，5091地段 | 2023-04-17 | 變更 |
| 74 | 脊柱手術(shù)器械 | 國械備20230220號(hào) | Medos International SARL | 見附件。 | 2023-04-17 | 有效 |
| 75 | 脊柱手術(shù)器械 | 國械備20210227號(hào) | Avalign Technologies, Inc. | 8727 Clinton Park Dr, Fort Wayne, IN USA 46825; 8414 Clinton Park Dr, Fort Wayne, IN USA 46825; 626 Cooper Ct, Schaumburg, IL USA 60173 | 2023-04-17 | 變更 |
| 76 | 內(nèi)鏡清洗機(jī) | 國械備20220223號(hào) | STEELCO SPA | VIA BALEGANTE 27-31039 RIESE PIO X(TV)-Italy | 2023-04-17 | 變更 |
| 77 | 口鏡 | 國械備20230219號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-17 | 有效 |
| 78 | 牙刮匙 | 國械備20230218號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-17 | 有效 |
| 79 | 牙科潔治器 | 國械備20230217號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-17 | 有效 |
| 80 | 牙骨膜分離器 | 國械備20230216號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-17 | 有效 |
| 81 | 脊柱固定系統(tǒng)手術(shù)工具 | 國械備20160103號(hào) | Pioneer Surgical Technology,Inc. | 375 River Park Circle,Marquette,MI 49855 | 2023-04-16 | 無效 |
| 82 | 顯微鑷 | 國械備20150527號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraβe 7A, 63791 Karlstein, Germany | 2023-04-14 | 變更 |
| 83 | 清洗脫蠟液 | 國械備20230215號(hào) | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES | 2023-04-14 | 有效 |
| 84 | 細(xì)胞角蛋白8&18抗體試劑(免疫組織化學(xué)) | 國械備20230214號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES | 2023-04-14 | 有效 |
| 85 | MC抗體試劑（免疫組織化學(xué)） | 國械備20230213號(hào) | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES | 2023-04-14 | 有效 |
| 86 | 牙周探針 | 國械備20230212號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-14 | 有效 |
| 87 | 剔挖器 | 國械備20230211號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-14 | 有效 |
| 88 | 牙用充填器 | 國械備20230210號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-14 | 有效 |
| 89 | 牙探針 | 國械備20230209號(hào) | Ray-Bright Industries | Near Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan | 2023-04-14 | 有效 |
| 90 | 比濁儀 | 國械備20210523號(hào) | Becton，Dickinson and Company | 100 Dayton Avenue, Ames, IA 50010, USA | 2023-04-14 | 變更 |
| 91 | CD1a抗體試劑（免疫組織化學(xué)） | 國械備20230208號(hào) | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES | 2023-04-13 | 有效 |
| 92 | Smooth Muscle Myosin抗體試劑（免疫組織化學(xué)） | 國械備20230207號(hào) | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES | 2023-04-13 | 有效 |
| 93 | 血管鉗 | 國械備20150528號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraβe 7A, 63791 Karlstein, Germany | 2023-04-13 | 變更 |
| 94 | 咬骨鉗 | 國械備20190134號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraße 7A, 63791 Karlstein Germany | 2023-04-13 | 變更 |
| 95 | 樣本稀釋液 | 國械備20191257號(hào) | Siemens Healthcare Diagnostics Inc. | 333 Coney Street, East Walpole, MA, 02032, United States | 2023-04-13 | 變更 |
| 96 | 樣本釋放劑 | 國械備20191256號(hào) | Siemens Healthcare Diagnostics Inc. | 333 Coney Street, East Walpole, MA, 02032, United States | 2023-04-13 | 變更 |
| 97 | 樣本稀釋液 | 國械備20160737號(hào) | Ortho-Clinical Diagnostics | Felindre Meadows PENCOED, BRIDGEND CF35 5PZ UNITED KINGDOM | 2023-04-13 | 變更 |
| 98 | 樣本稀釋液 | 國械備20150458號(hào) | Medirox AB | Studsvik, 611 82 NYKÖPING, Sweden | 2023-04-13 | 變更 |
| 99 | 一次性醫(yī)用丁腈橡膠手套 | 國械備20230206號(hào) | MEDICAL GLOVE CO.,LTD | 288 Moo 7, T.Lam Thap, A.Lam Thap, Krabi 81190 Thailand | 2023-04-13 | 有效 |
| 100 | 醫(yī)用橡膠檢查手套 | 國械備20230205號(hào) | MEDICAL GLOVE CO.,LTD | 288 Moo 7, T.Lam Thap, A.Lam Thap, Krabi 81190 Thailand | 2023-04-13 | 有效 |
| 101 | p120抗體試劑（免疫組織化學(xué)） BOND Ready-to-Use Primary Antibody p120 Catenin (EP66) | 國械備20190013號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2023-04-13 | 變更 |
| 102 | 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 | 2023-04-12 | 變更 |
| 103 | 組織染色機(jī) | 國械備20140169號(hào) | MEDITE Medical GmbH | 國械備20140169 | 2023-04-12 | 變更 |
| 104 | 輪轉(zhuǎn)式切片機(jī) | 國械備20140038號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2023-04-12 | 變更 |
| 105 | 冷凍切片機(jī) | 國械備20150255號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2023-04-12 | 變更 |
| 106 | 醫(yī)用檢查手套 | 國械備20230204號(hào) | HARTALEGA SDN.BHD. | NO.7,KAWASAN PERUSAHAAN SURIA,45600 | 2023-04-11 | 有效 |
| 107 | 雙移動(dòng)髖臼杯系統(tǒng)手術(shù)工具 | 國械備20230203號(hào) | SERF | 85 Avenue des Bruyères，69150 DECINES-CHARPIEU，F(xiàn)RANCE | 2023-04-11 | 有效 |
| 108 | CD43抗體試劑（免疫組織化學(xué)） | 國械備20190634號(hào) | Leica Biosystems Newcastle Ltd. | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. | 2023-04-11 | 變更 |
| 109 | PMS2抗體試劑（免疫組織化學(xué)） | 國械備20210586號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom | 2023-04-11 | 變更 |
| 110 | MSH6抗體試劑（免疫組織化學(xué)） | 國械備20210599號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom | 2023-04-11 | 變更 |
| 111 | Mammaglobin抗體試劑（免疫組織化學(xué)）BOND Ready-to-Use Primary Antibody Mammaglobin (EP249) | 國械備20190014號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2023-04-11 | 變更 |
| 112 | CD103抗體試劑（免疫組織化學(xué)法） | 國械備20191113號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom | 2023-04-11 | 變更 |
| 113 | Human Growth Hormone抗體試劑（免疫組織化學(xué)） | 國械備20190631號(hào) | Leica Biosystems Newcastle Ltd. | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. | 2023-04-11 | 變更 |
| 114 | 抗 PRAME（EPR20330)兔單克隆抗體（免疫組織化學(xué)法) | 國械備20230202號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2023-04-11 | 有效 |
| 115 | CA 19-9抗體試劑（免疫組織化學(xué)） BOND Ready-to-Use Primary Antibody CA19-9 (Sialyl Lewis<sup>a</sup>) (C241:5:1:4) | 國械備20190006號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2023-04-11 | 變更 |
| 116 | 鏟式擔(dān)架 | 國械備20151329號(hào) | ME.BER S.r.l. Unipersonale | Via Langhirano, 270 l-43124 FONTANINI (PR) | 2023-04-11 | 變更 |
| 117 | 擔(dān)架 | 國械備20151328號(hào) | ME.BER S.r.l. Unipersonale | Via Langhirano, 270 l-43124 FONTANINI (PR) | 2023-04-11 | 變更 |
| 118 | 救護(hù)車擔(dān)架 | 國械備20151325號(hào) | ME.BER S.r.l. Unipersonale | Via Langhirano, 270 l-43124 FONTANINI (PR) | 2023-04-11 | 變更 |
| 119 | 樓梯擔(dān)架 | 國械備20151323號(hào) | ME.BER S.r.l. Unipersonale | Via Langhirano, 270 l-43124 FONTANINI (PR) | 2023-04-11 | 變更 |
| 120 | 吸引管 | 國械備20170144號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraβe 7A, 63791 Karlstein, Germany | 2023-04-07 | 變更 |
| 121 | 顯微剪 | 國械備20150526號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraβe 7A, 63791 Karlstein, Germany | 2023-04-07 | 變更 |
| 122 | 外科牽開器 | 國械備20151609號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraβe 7A D-63791 Karlstein | 2023-04-07 | 變更 |
| 123 | 持針鉗 | 國械備20150107號(hào) | FEHLING INSTRUMENTS GmbH & Co. KG | Hanauer Landstraβe 7A, 63791 Karlstein, Germany | 2023-04-07 | 變更 |
| 124 | 牙科輸送頭 | 國械備20230201號(hào) | 株式會(huì)社松風(fēng) | 茨城県笠間市長兎路1320番地5 | 2023-04-06 | 有效 |
| 125 | 牙科刮治器 | 國械備20151611號(hào) | LASCOD S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA) | IT-50019 SESTO FIORENTINO (FI)-VIA L.LONGO, 18 | 2023-04-06 | 變更 |
| 126 | 種植體清潔刷 | 國械備20190863號(hào) | Neobiotech Co., Ltd. | 102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 608, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul/ 104,24, Digital-ro 27-gil, Guro-gu,Seoul/ 1F, 60 Gasan digital 2-ro, Geumcheon-gu Seoul, Korea Rep. | 2023-04-06 | 變更 |
| 127 | 呼吸訓(xùn)練器 | 國械備20150135號(hào) | / | C/ Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain | 2023-04-06 | 變更 |
| 128 | 骨科手術(shù)器械 | 國械備20230200號(hào) | Synthes GmbH | Unter Hasslen 5, 78532 Tuttlingen, Germany; Im Bifang 6, 4614 Hägendorf, Switzerland | 2023-04-06 | 有效 |
| 129 | 醫(yī)用檢查手套 | 國械備20210120號(hào) | Supermax Glove Manufacturing Sdn. Bhd. | Lot 38,Putra Industrial Park, Bukit Rahman Putra 47000 Sungai Buloh, Selangor Darul Ehsan MALAYSIA | 2023-04-04 | 變更 |
| 130 | 脊柱固定系統(tǒng)手術(shù)工具包 | 國械備20160952號(hào) | Pioneer Surgical technology,Inc. | 375 River Park Circle Marquette, Marquette, Michigan, 49855 USA | 2023-04-04 | 變更 |
| 131 | 牙科骨磨 | 國械備20230199號(hào) | Storz am Mark GmbH | Emminger Straße 39 78576 Emmingen-Liptingen Germany | 2023-04-04 | 有效 |
| 132 | 樣本稀釋液 | 國械備20230198號(hào) | Roche Diagnostics GmbH | Sandhofer Strasse 116, 68305 Mannheim,Germany | 2023-04-04 | 有效 |
| 133 | 手術(shù)剪 | 國械備20150929號(hào) | Max Hauser Süddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33，78532 Tuttlingen Germany | 2023-04-04 | 變更 |
| 134 | 骨科固定帶 | 國械備20181589號(hào) | Bauerfeind AG | Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany | 2023-04-04 | 變更 |
| 135 | 耳鼻喉用鑷 | 國械備20230197號(hào) | Berger Surgical Medical Products GmbH | Take-off-Gewerbepark 4,D-78579 Neuhausen ob Eck, Germany | 2023-04-04 | 有效 |
| 136 | 耳針 | 國械備20230196號(hào) | Berger Surgical Medical Products GmbH | Take-off-Gewerbepark 4,D-78579 Neuhausen ob Eck, Germany | 2023-04-04 | 有效 |
| 137 | 牙科手術(shù)器械包 | 國械備20180108號(hào) | DENTSPLY Implants Manufacturing GmbH | 見附頁。 | 2023-04-04 | 變更 |
| 138 | 顯微鑷 | 國械備20190406號(hào) | 株式會(huì)社高山醫(yī)療機(jī)械製作所 | 東京都臺(tái)東區(qū)谷中3-4-4 | 2023-04-03 | 變更 |
| 139 | 醫(yī)用檢查手套 | 國械備20230195號(hào) | PT Latexindo Tobaperkasa | JI. Binjai Km 11, Mulyorejo – Sunggal 20352, Deli Serdang Indonesia | 2023-04-03 | 有效 |
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