| 产品名称 | 备案号 | 备案人名称原文 | 生产地址原文 |
| 增强液 | 国械备20151617号 | Wallac Oy | Mustionkatu 6, FI-20750 Turku, Finland |
| 种植辅助材料 | 国械备20230185号 | Medigma Biomedical GmbH | Siemensstra?e 10 78564 Wehingen Germany |
| 种植安装辅助工具 | 国械备20230184号 | Medigma Biomedical GmbH | Siemensstra?e 10 78564 Wehingen Germany |
| MTAP 抗体试剂（免疫组织化学） | 国械备20260251号 | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA |
| 跗骨手术工具 | 国械备20190168号 | GraMedica | 16137 Leone Drive, Macomb, MI, 48042, United States |
| CD33抗体试剂（免疫组织化学法） | 国械备20230594号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| 细胞角蛋白8&18抗体试剂（免疫组织化学） | 国械备20190565号 | Leica Biosystems Newcastle Ltd. | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. |
| CD21抗体试剂（免疫组织化学） BOND Ready-to-Use Primary Antibody CD21 (2G9) | 国械备20190198号 | Leica Biosystems Newcastle Ltd. | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. |
| CD79a抗体试剂 | 国械备20250185号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| Ki-67抗体试剂 | 国械备20240246号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| AE1/AE3混合分子量角蛋白抗体试剂 | 国械备20240244号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| 间皮素（Mesothelin）抗体试剂（免疫组织化学法） BOND Ready-to-Use Primary Antibody Mesothelin (5B2) | 国械备20190117号 | Leica Biosystems Newcastle Ltd. | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom. |
| CMV探针试剂（原位杂交法） | 国械备20240446号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| 免疫显色试剂 | 国械备20240278号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| 待测物清洗液 | 国械备20240447号 | Leica Biosystems Newcastle Ltd | Leica Biosystems Newcastle Ltd |
| 免疫显色试剂 | 国械备20250186号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom |
| 牙科手术工具 | 国械备20170763号 | Cowellmedi co.,Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| 髂骨取出器 | 国械备20180136号 | Cowellmedi co.,Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| 口腔观察仪 | 国械备20260250号 | AIOBIO Co.,Ltd. | #401, 4F, Building B, 182, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, 16648, Republic of Korea |
| 全自动样品处理系统 | 国械备20181268号 | Siemens Healthcare Diagnostics Inc. | 62 Flanders-Bartley Road, Flanders, New Jersey 07836, USA |
| 牙挺 | 国械备20151740号 | Hu-Friedy Mfg. Co., LLC | 3232 N. Rockwell Street, Chicago, IL 60618, United States |
| 牙用分离器 | 国械备20151443号 | Hu-Friedy Mfg. Co., LLC | 3232 N. Rockwell Street, Chicago, IL 60618, United States |
| 口腔科手术器械 | 国械备20260249号 | IBBI DENTAL INSTRUMENTS | Haji Pura,Amba Wali Chapri,Near Dera Ch. Ansar. Sialkot Pakistan |
| 头皮拉钩 | 国械备20260248号 | ミズホ株式会社 | 新潟県五泉市赤海3631番14 |
| 口腔照明灯 | 国械备20260209号 | AIOBIO Co.,Ltd. | 4F-401,Building B,182,Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do,16648,Republic of Korea |
| 口腔观察仪 | 国械备20250402号 | AIOBIO Co.,Ltd. | #306, 555, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
| 头戴式检查灯 | 国械备20240180号 | (?)?????? | ????? ?? ????180?? 273? |
| 医用放大镜 | 国械备20191216号 | (?)?????? | ????? ???? ??? 148 (???) |
| 螺丝起 | 国械备20250444号 | BioMaterials Korea, Inc. | #329, #331, #413, 150, Jojeong-daero, Hanam-si, Gyeonggi-do, Korea Rep. |
| 螺丝起 | 国械备20250445号 | BioMaterials Korea, Inc. | #329, #331, #413, 150, Jojeong-daero, Hanam-si, Gyeonggi-do, Korea Rep. |
| 倒置生物显微镜 | 国械备20250436号 | Leica Microsystems CMS GmbH | Ernst-Leitz-Stra?e 17-37, 35578 Wetzlar, GERMANY |
| 牙科抛光磨头 | 国械备20230482号 | EVE Ernst Vetter GmbH | Neureutstr.6, 75210 Keltern, Germany |
| 牙科抛光碟 | 国械备20240222号 | EVE Ernst Vetter GmbH | Neureutstr.6, 75210 Keltern, Germany |
| 医用射线防护用品及装置 | 国械备20260247号 | MAVIG GmbH | Stahlgruberring 5，81829 München, GERMANY |
| 痰消化液 BD BBL? MycoPrep? Kit | 国械备20160600号 | Becton, Dickinson and Company | 411 East Jarvis Avenue, Des Plaines, IL 60018, USA |
| 动力系统配套工具 | 国械备20181767号 | Synthes GmbH | Eimattstrasse 3, 4436 Oberdorf, Switzerland |
| 染色机 | 国械备20161960号 | BioGenex Laboratories Inc. | 49026 Milmont Drive,Fremont California 94538,USA/Plot No. 4 Survey No.656/A Aero Space and Precision Engineering Industries SEZ. Adibatla(V),Ibrahimpatnam(M,) Ranga Reddy District, Telangana 501 510 India. |
| 染色机 | 国械备20180824号 | BioGenex Laboratories Inc. | 49026 Milmont Drive,Fremont CA 94538,USA |
| DAB染色液 | 国械备20181372号 | BioGenex Laboratories Inc. | 49026 Milmont Drive,Fremont CA 94538,USA |
| 造口袋 | 国械备20181323号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic |
| 口镜 | 国械备20160326号 | Hu-Friedy Mfg.Co.,LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States |
| 刮治器 | 国械备20151442号 | Hu-Friedy Mfg.Co.,LLC | 3232 N. Rockwell Street, Chicago, IL 60618, United States |
| 牙探针 | 国械备20161105号 | Hu-Friedy Mfg. Co., LLC | 3232 N. Rockwell Street, Chicago, IL 60618, United States |
| 正畸钳 | 国械备20151231号 | Hu-Friedy Mfg. Co., LLC | 美国伊利诺斯州芝加哥市北罗克韦尔大街3232号 |
| 刚果红染色液 | 国械备20260246号 | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA |
| 革兰染色液 | 国械备20260245号 | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA |
| 钛微型闭合钳 | 国械备20260244号 | Heinz Kurz GmbH | Daimlerstra?e 18, 78665 Frittlingen, Germany |
| CD7抗体试剂（流式细胞仪法-FITC） CD7-FITC | 国械备20180789号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD79a抗体试剂（流式细胞仪法-PE) CD79a-PE | 国械备20180301号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD56抗体试剂（流式细胞仪法-PC7） CD56-PC7 | 国械备20180318号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD5抗体试剂（流式细胞仪法-PE） CD5-PE | 国械备20180799号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD4抗体试剂（流式细胞仪法-PC5) CD4-PC5 | 国械备20180795号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD4抗体试剂（流式细胞仪法-PE）CD4-PE | 国械备20180727号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD4抗体试剂（流式细胞仪法-FITC） CD4-FITC | 国械备20180798号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD3抗体试剂（流式细胞仪法-PC5) CD3-PC5 | 国械备20180803号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD3抗体试剂（流式细胞仪法-ECD） CD3-ECD | 国械备20180316号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD3抗体试剂（流式细胞仪法-FITC） CD3-FITC | 国械备20180802号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| CD2抗体试剂（流式细胞仪法-FITC） CD2-FITC | 国械备20180785号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France |
| 扭力扳手 | 国械备20170499号 | Hager & Meisinger GmbH | Hansemannstraβe 10, 41468 Neuss, Deutschland |
| 鼻氧管 | 国械备20200330号 | Dr?gerwerk AG & Co. KGaA | No. 312, Jhongshan Rd. Shengang District, Taichung City 429, Taiwan |
| 螺丝起 | 国械备20260243号 | Dentos Inc. | 41, Seongseo-ro 68-gil, Dalseo-gu, Daegu, Korea |
| 自粘弹性绷带 | 国械备20260242号 | BSN medical GmbH | SF - 29 & 30, Perumpali, Semmipalayam, Trichy Road, Palladam, Tiruppur, Tamil Nadu 641662, INDIA |
| 牙挺 | 国械备20170080号 | POMEE USA INC | MIAN ILAM DIN ROAD, DOBURJI ARIAN SIALKOT, PUNJAB, 51310, PAKISTAN |
| 拔牙钳 | 国械备20170127号 | POMEE USA INC | MIAN ILAM DIN ROAD, DOBURJI ARIAN SIALKOT, PUNJAB, 51310, PAKISTAN |
| 手动轮椅车 | 国械备20260240号 | Sunrise Medical GmbH | Kahlbachring 2-4, D 69254 Malsch/Heidelberg,Germany; ul. Mosi??na 24, 66-400 Gorzów Wielkopolski, PL |
| 种植体安装辅助器械 | 国械备20260186号 | ARUM DENTISTRY Co., Ltd. | 23, Gukjegwahak 11-ro, Yuseong-gu, Daejeon, 34002, Korea |
| 口腔X射线摄片架 | 国械备20170032号 | Kerr Italia S.r.l. | Via Strecce 4 P.O. 272 6934 Bioggio Switzerland |
| 研光器 | 国械备20170103号 | Kerr Italia S.r.l. | Via Strecce 4 P.O. 272 6934 Bioggio Switzerland |
| 研光器 | 国械备20161043号 | Kerr Italia S.r.l. | Via Strecce 4 P.O. 272 6934 Bioggio Switzerland |
| 根管充填器 | 国械备20160553号 | Kerr Italia S.r.l. | 1332 South Lone Hill Avenue Glendora, California 91740 USA;Calle 21 No 1103 AMP CD Industrial Uman Yucatan 97390 Mexico |
| 医用外固定支具 | 国械备20161756号 | DJO, LLC | 1）1430 Decision Street Vista, California, 92081, USA；2）Carretera Libre Tijuana Tecate #20230 Submetropoli El Florido, Tijuana B. C. Mexico 22244 |
| 牙科种植定位器 | 国械备20151313号 | Cortex Dental Implants Industries Ltd. | Shlomi Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel |
| 扭力扳手 | 国械备20140227 号 | Cortex Dental Implants Industries LTD | Shlomi Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel |
| 口腔手术器械 | 国械备20181405号 | Cortex Dental Implants Industries Ltd. | Shlomi Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel |
| 种植体手术工具 | 国械备20151307号 | Cortex Dental Implants Industries Ltd. | Shlomi Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel |
| 牙科种植体手术工具包 | 国械备20161141号 | Cortex Dental Implants Industries LTD | Shlomi Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel |
| 螺丝起 | 国械备20140226号 | Cortex Dental Implants Industries LTD | Shlomi Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel |
| 牙用探针 | 国械备20151312号 | Cortex Dental Implants Industries Ltd. | Shlomi Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel |
| 种植体扫描体 | 国械备20171019号 | Cortex Dental Implants Industries Ltd. | Shlomi Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel |
| 手术台 | 国械备20151601号 | 鼎眾股份有限公司 | 桃園縣龜山鄉樂善村文化一路75號 |
| 牙用尺 | 国械备20152146号 | Cowellmedi co., Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| 牙科种植工具 | 国械备20151813号 | Cowellmedi co., Ltd. | 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan,617-801, Republic of Korea |
| 牙科种植定位器 | 国械备20160170号 | Cowellmedi co.,Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| 软组织环切刀 | 国械备20160008号 | Cowellmedi co.,Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| 铁染色液 Artisan Iron Stain Kit | 国械备20150390号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States |
| 刚果红染色液 Artisan Congo Red Stain Kit | 国械备20140208号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States |
| 阿利辛蓝染色液 Artisan Alcian Blue pH 2.5 Stain Kit | 国械备20140209号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States |
| 细胞角蛋白（广谱）抗体试剂（免疫组织化学） | 国械备20180335号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States |
| 清洗液 Artisan 50x Wash Solution | 国械备20150166号 | Agilent Technologies, Inc. | 6392 Via Real Carpinteria, CA 93013 |
| 钻针深度停止器 | 国械备20152154号 | Cowellmedi co., Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| DAB染色液 | 国械备20170968号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013, USA |
| 抗体稀释液 | 国械备20171028号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013, United States |
| 转移帽 | 国械备20152147号 | Cowellmedi co., Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| MLH1抗体试剂（免疫组织化学） | 国械备20180763号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| MSH2抗体试剂（免疫组织化学） | 国械备20180768号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| 口垫 | 国械备20180138号 | Cowellmedi co.,Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| MSH6抗体试剂（免疫组织化学） | 国械备20180760号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| PMS2 抗体试剂（免疫组织化学） | 国械备20180762号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| 清洗脱蜡液 | 国械备20230215号 | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES |
| W-S银染色液 | 国械备20220295号 | Agilent Technologies,Inc. | 1170 Mark Ave, Carpinteria, California 93013 United States |
| 阿利辛蓝－过碘酸雪夫氏染色液 | 国械备20230222号 | Agilent Technologies,Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES |
| 牙科种植辅助工具 | 国械备20170765号 | Cowellmedi co.,Ltd. | 48, Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea |
| 口腔科手术器械 | 国械备20260239号 | ALFALAH INDUSTRIES | Ugoki Road, Bhabarian Wala, SIALKOT -51310-PAKISTAN. |
| 牙科刮治器 | 国械备20230363号 | 株式会社YDM | 埼玉県東松山市今泉28番地 |
| 荧光生物显微镜 | 国械备20260238号 | EUROIMMUN Medizinische Labordiagnostika AG | An der Trave 1, 23923 Selmsdorf, Germany |
| 髋关节手术器械 | 国械备20260237号 | Blue Belt Technologies, Inc. | 76 South Meridian Ave, Oklahoma City, Oklahoma, 73107-6512 USA |
| 自动加样系统 | 国械备20240131号 | Becton, Dickinson and Company, BD Biosciences | Neuwiesenstrasse 4, 8222 Beringen, Switzerland |
| 弹性纤维染色液 Artisan Elastic Stain Kit | 国械备20140263号 | Agilent Technologies, Inc. | 6392 Via Real Carpinteria, CA 93013 |
| 抗酸染色液 Artisan Acid-Fast Bacillus (AFB) Stain Kit | 国械备20140022号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| 吉姆萨染色液 Artisan Giemsa Stain Kit | 国械备20140206号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93014 United States |
| 过碘酸雪夫染色液 Artisan Periodic Acid Schiff Stain Kit | 国械备20140021号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93015 United States |
| Masson三色染色液 Artisan Masson's Trichrome Stain Kit | 国械备20140023号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93016 United States |
| 粘蛋白胭脂红染色液 Artisan Mucicarmine Stain Kit | 国械备20140210号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93017 United States |
| 六胺银染色液 Artisan Grocott’s Methenamine Silver Stain Kit | 国械备20140207号 | Agilent Technologies, Inc. | 6392 Via Real Carpinteria, CA 93013 |
| 胶体铁染色液 | 国械备20240133号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES |
| 琼斯苏木素伊红染色液 | 国械备20240135号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES |
| 网状纤维染色液 Artisan Reticulin-No Counterstain Kit | 国械备20140212号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| 网状纤维染色液 Artisan Reticulin-Nuclear Fast Red Stain Kit | 国械备20140204号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States |
| 琼斯核固红染色液 | 国械备20240134号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES |
| Caldesmon抗体试剂（免疫组织化学） | 国械备20181789号 | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States |
| 淀粉酶溶液 | 国械备20240132号 | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, California 93013 UNITED STATES |
| 种植体扫描体 | 国械备20250067号 | Terrats Medical S.L. | C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain |
| 替代体 | 国械备20240273号 | Terrats Medical S.L. | C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain |
| 种植体扫描体 | 国械备20240276号 | Terrats Medical S.L. | C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain |
| 医用硅胶压敏胶带 | 国械备20200087号 | Solventum Germany GmbH | Edisonstraβe 6, 59174 Kamen, Germany |
| 医用硅胶压敏胶带 | 国械备20240345号 | Solventum Germany GmbH | Edisonstraβe 6, 59174 Kamen, Germany |
| 螺丝起 | 国械备20150871号 | ???????(?) | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea |
| 医用外固定支具 | 国械备20161152号 | DJO,LLC | Carretera Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana |