| 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 | 種植體安裝輔助器械 | 國(guó)械備20230513號(hào) | Oneday Biotech Co., Ltd. | C-135, Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea | 2023-10-31 | 有效 |
| 2 | 種植輔助材料 | 國(guó)械備20230512號(hào) | Oneday Biotech Co., Ltd. | C-135, Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea | 2023-10-31 | 有效 |
| 3 | 牙科種植掃描體 | 國(guó)械備20230511號(hào) | Oneday Biotech Co., Ltd. | C-135, Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea | 2023-10-31 | 有效 |
| 4 | 清洗液 | 國(guó)械備20230510號(hào) | Siemens Healthcare Diagnostics Inc. | 500 GBC Drive, P.O. Box 6101 Newark, DE, 19714, USA | 2023-10-30 | 有效 |
| 5 | 清洗液 | 國(guó)械備20230509號(hào) | Siemens Healthcare Diagnostics Inc. | Northern Road, Chilton Industrial Estate, Sudbury, Suffolk CO10 2XQ, UK | 2023-10-30 | 有效 |
| 6 | 口腔科手術(shù)器械 | 國(guó)械備20230508號(hào) | IBBI DENTAL INSTRUMENTS | Haji Pura (Amba Wali Chapri) Near Dera Ch Ansar, Sialkot-Pakistan. | 2023-10-27 | 有效 |
| 7 | 口腔科手術(shù)器械 | 國(guó)械備20220065號(hào) | Vitra International | Marala Road 51360,Sialkot-Pakistan | 2023-10-27 | 變更 |
| 8 | 根管擴(kuò)大器 | 國(guó)械備20220106號(hào) | 株式會(huì)社背戸製作所 | 茨城県つくば市小田4596の1 | 2023-10-27 | 變更 |
| 9 | 醫(yī)用射線防護(hù)用品及裝置 | 國(guó)械備20230507號(hào) | Barrier Technologies, LLC | 7060 W. State Rd 84, Suite 8, Davie, Florida, 33317, United States | 2023-10-25 | 有效 |
| 10 | 自動(dòng)加樣系統(tǒng) | 國(guó)械備20230506號(hào) | シスメックス株式會(huì)社 | 18735 Madrone Parkway Morgan Hill, CA 95037 United States of America | 2023-10-25 | 有效 |
| 11 | 髖關(guān)節(jié)手術(shù)工具 | 國(guó)械備20230505號(hào) | Zimmer Inc. | 1800 W. Center Street Warsaw Indiana 46580 USA | 2023-10-25 | 有效 |
| 12 | 骨科牽引架 | 國(guó)械備20230259號(hào) | Allen Medical Systems, Inc. | 100 Discovery Way Acton, MA 01720 USA | 2023-10-24 | 變更 |
| 13 | 口腔科手術(shù)器械 | 國(guó)械備20230504號(hào) | TITAN SURGICAL CO. | Adalat Ghara Nia,Sialkot-Pakistan | 2023-10-24 | 有效 |
| 14 | 手術(shù)肌腱整理平臺(tái) | 國(guó)械備20200045號(hào) | Arthrex,Inc. | 6875 Arthrex Commerce Drive Ave Maria, FL USA 34142 | 2023-10-23 | 變更 |
| 15 | 細(xì)胞角蛋白（廣譜）抗體試劑（免疫組織化學(xué)） | 國(guó)械備20190048號(hào) | Ventana Medical Systems, Inc. | 1910E.Innovation Park Drive Tucson,Arizona 85755 USA | 2023-10-23 | 變更 |
| 16 | 清洗液 | 國(guó)械備20230503號(hào) | キヤノンメディカルシステムズ株式會(huì)社 | 1359-1 Kagamida, Kigoshi, Gosen-shi, Niigata,959-1695 Japan | 2023-10-20 | 有效 |
| 17 | 牙科種植工具包 | 國(guó)械備20230502號(hào) | Noris Medical Ltd. | 8 Hataasia St., Nesher 3688808 | 2023-10-19 | 有效 |
| 18 | 手術(shù)拉鉤 | 國(guó)械備20150082號(hào) | FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH | Prager Ring 70, 52070 Aachen, Germany | 2023-10-19 | 變更 |
| 19 | 醫(yī)用冰墊 | 國(guó)械備20150159號(hào) | 彪仕醫(yī)技股份有限公司 | 臺(tái)南市南區(qū)中華西路一段23號(hào) | 2023-10-19 | 無效 |
| 20 | 低速臺(tái)式離心機(jī) | 國(guó)械備20230501號(hào) | 株式會(huì)社久保田製作所 | 群馬県藤岡市中大塚1065-3 | 2023-10-19 | 有效 |
| 21 | 低速冷凍離心機(jī) | 國(guó)械備20230500號(hào) | 株式會(huì)社久保田製作所 | 群馬県藤岡市中大塚1065-3 | 2023-10-19 | 有效 |
| 22 | 替代體 | 國(guó)械備20230499號(hào) | VIDA DENTAL SAN. VE T?C. A.?. | 600 Evler Mah. Bal?kesir Asf. Sol Taraf Cad. ünallar Sitesi No: 10 Band?rma BALIKES?R / TURKEY | 2023-10-19 | 有效 |
| 23 | 免疫組化抗原修復(fù)緩沖液Novocastra Epitope Retrieval Solution pH9 | 國(guó)械備20160676號(hào) | Leica Biosystems Newcastle Ltd | Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom | 2023-10-18 | 變更 |
| 24 | 脫蠟液 BOND Dewax Solution | 國(guó)械備20140293號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2023-10-18 | 變更 |
| 25 | 免疫組化抗原修復(fù)緩沖液Novocastra Epitope Retrieval Solution pH6 | 國(guó)械備20160677號(hào) | Leica Biosystems Newcastle Ltd | Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom | 2023-10-18 | 變更 |
| 26 | 樣本稀釋液 | 國(guó)械備20210596號(hào) | 富士レビオ株式會(huì)社 | 日本國(guó)東京都八王子市小宮町51番地 | 2023-10-18 | 變更 |
| 27 | 樣本稀釋液 | 國(guó)械備20160414號(hào) | 富士レビオ株式會(huì)社 | 東京都八王子市小宮町51番地 | 2023-10-18 | 變更 |
| 28 | 全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液 | 國(guó)械備20160413號(hào) | 富士レビオ株式會(huì)社 | 東京都八王子市小宮町５１番地 | 2023-10-18 | 變更 |
| 29 | 手術(shù)用動(dòng)力手柄連接套管（帶參考架） | 國(guó)械備20230498號(hào) | Medtronic Powered Surgical Solutions | 4620 North Beach Street Fort Worth Texas 76137 USA | 2023-10-17 | 有效 |
| 30 | Gomori 三色染色液（綠） | 國(guó)械備20230497號(hào) | Leica Biosystems Richmond, Inc. | 5205 Route 12, P.O.Box 528, Richmond, Illinois 60071, USA | 2023-10-17 | 有效 |
| 31 | 夾持鉗 | 國(guó)械備20230496號(hào) | FENTEXmedical GmbH | take-off Gewerbepark 2 78579 Neuhausen Ob Eck Germany | 2023-10-17 | 有效 |
| 32 | 骨用牽開器 | 國(guó)械備20230495號(hào) | Thompson Surgical Instruments, Inc. | 10341 E. Cherry Bend Road, Traverse City, MI, 49684 United States of America | 2023-10-17 | 有效 |
| 33 | Gomori 三色染色液（藍(lán)） | 國(guó)械備20230494號(hào) | Leica Biosystems Richmond, Inc. | 5205 Route 12, P.O.Box 528, Richmond, Illinois 60071, USA | 2023-10-17 | 有效 |
| 34 | 組織固定液 O-FIX | 國(guó)械備20160444號(hào) | Leica Biosystems Richmond,Inc. | 5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA | 2023-10-17 | 變更 |
| 35 | 染色機(jī) | 國(guó)械備20140016號(hào) | Leica Biosystems Melbourne Pty Ltd | 495 Blackburn Road Mt Waverley Victoria 3149 Australia | 2023-10-16 | 變更 |
| 36 | 自動(dòng)組織脫水機(jī) | 國(guó)械備20180309號(hào) | Leica Biosystems Melbourne Pty Ltd | 495 Blackburn Road, Mount Waverley, VIC3149, Australia | 2023-10-16 | 變更 |
| 37 | 染色機(jī) | 國(guó)械備20140277號(hào) | Leica Biosystems Melbourne Pty Ltd | 495 Blackburn Road Mt Waverley Victoria 3149 Australia | 2023-10-16 | 變更 |
| 38 | 過碘酸雪夫染色液 | 國(guó)械備201619640號(hào) | Leica Biosystems Richmond, Inc. | 5205 Route 12 P.O. Box 528 Richmond Illinois 60071 USA | 2023-10-16 | 無效 |
| 39 | 阿利辛藍(lán)－過碘酸雪夫氏染色液 | 國(guó)械備20161937號(hào) | Leica Biosystems Richmond, Inc. | 5205 Route 12 P.O. Box 528 Richmond Illinois 60071 USA | 2023-10-16 | 無效 |
| 40 | 醫(yī)用圖像打印機(jī) | 國(guó)械備20140244號(hào) | / | Max-Planck-Strasse 1, 82380 Peiβenberg, Germany | 2023-10-16 | 變更 |
| 41 | CD123檢測(cè)試劑（流式細(xì)胞儀法） | 國(guó)械備20230493號(hào) | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-10-16 | 有效 |
| 42 | CD4檢測(cè)試劑 | 國(guó)械備20230492號(hào) | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-10-16 | 有效 |
| 43 | CD117檢測(cè)試劑 | 國(guó)械備20210480號(hào) | BioLegend, Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-10-16 | 變更 |
| 44 | CD14檢測(cè)試劑 | 國(guó)械備20230491號(hào) | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-10-16 | 有效 |
| 45 | 造口袋 | 國(guó)械備20200543號(hào) | Coloplast A/S | Búzavirág út 15, 2800 Tatabánya, Hungary /Calle 58, Zona Franca La Lima, La Lima, Guadalupe, 30106 Cartago, Costa Rica | 2023-10-13 | 變更 |
| 46 | 二件式造口袋 | 國(guó)械備20190784號(hào) | Coloplast A/S | Coloplast Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary | 2023-10-13 | 變更 |
| 47 | 橡皮障夾鉗 | 國(guó)械備20230490號(hào) | Secure Dental Company | Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 – Pakistan | 2023-10-13 | 有效 |
| 48 | 橡皮障支架 | 國(guó)械備20230489號(hào) | Secure Dental Company | Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan | 2023-10-13 | 有效 |
| 49 | 壓力繃帶 | 國(guó)械備20171055號(hào) | MAXIS a.s. | Francouzska 171/28, 12000 Praha 2 – Vinohrady, Czech Republic | 2023-10-13 | 變更 |
| 50 | FOXO1（13q14）基因斷裂探針試劑（熒光原位雜交法） | 國(guó)械備20230488號(hào) | Kreatech Biotechnology B.V. | Vlierweg 20, 1032 LG Amsterdam, The Netherlands | 2023-10-12 | 有效 |
| 51 | 液體敷料 | 國(guó)械備20190860號(hào) | ConvaTec Limited | Units 12A & 12B kings Court, Prince William Avenue, Sandycroft, Deeside CH5 2FG, United Kingdom | 2023-10-12 | 無效 |
| 52 | 脊柱手術(shù)器械 | 國(guó)械備20210228號(hào) | Synthes GmbH | Industriestrasse 28, 2545 Selzach, Switzerland | 2023-10-12 | 變更 |
| 53 | 脊柱微創(chuàng)手術(shù)工具包 | 國(guó)械備20190164號(hào) | Medos International SARL | 50 Scotland Blvd, Bridgewater Massachusetts, 02324 USA | 2023-10-12 | 變更 |
| 54 | 固定用彈力束帶 | 國(guó)械備20181484號(hào) | Bauerfeind AG | Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany | 2023-10-12 | 變更 |
| 55 | 牙科手術(shù)器械包 | 國(guó)械備20230487號(hào) | AMMAR INDUSTRIES | Near Ballanwala Post Office, Infront of Jamia Masjid Muhammadi Ahlayhadees, Sialkot - Pakistan | 2023-10-12 | 有效 |
| 56 | 緩沖液 | 國(guó)械備20200682號(hào) | RAL DIAGNOSTICS | Site Montesquieu 33650 MARTILLAC FRANCE | 2023-10-12 | 變更 |
| 57 | 橡皮障打孔器 | 國(guó)械備20230486號(hào) | Secure Dental Company | Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan | 2023-10-12 | 有效 |
| 58 | 橡皮障夾 | 國(guó)械備20230485號(hào) | Secure Dental Company | Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan | 2023-10-12 | 有效 |
| 59 | 自動(dòng)加樣系統(tǒng) | 國(guó)械備20230484號(hào) | Beckman Coulter, Inc. | 11800 SW 147TH AVE Miami, FL USA 33196 | 2023-10-12 | 有效 |
| 60 | 全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液 | 國(guó)械備20230483號(hào) | Beckman Coulter, Inc. | 1000 Lake Hazeltine Drive, Chaska, MN 55318-1084 | 2023-10-12 | 有效 |
| 61 | 創(chuàng)口貼 | 國(guó)械備20200613號(hào) | / | / | 2023-10-12 | 變更 |
| 62 | 牙科拋光磨頭 | 國(guó)械備20230482號(hào) | EVE Ernst Vetter GmbH | Neureutstr.6, 75210 Keltern, Germany | 2023-10-10 | 有效 |