| 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 | 備案日期 |
| 1 | Alpha-1-Fetoprotein抗體試劑（免疫組織化學(xué)） | 國械備20190480號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-06-30 |
| 2 | Hepatocyte抗體試劑（免疫組織化學(xué)） | 國械備20180371號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-06-30 |
| 3 | 噴劑敷料 | 國械備20200222號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 4 | 噴劑敷料 | 國械備20200239號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 5 | 液體傷口敷料 | 國械備20200165號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 6 | 液體傷口敷料 | 國械備20210104號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 7 | 液體傷口敷料 | 國械備20210114號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 8 | 乳頭皸裂傷口護(hù)理軟膏包 | 國械備20191217號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 9 | 妊娠紋傷口護(hù)理軟膏包 | 國械備20200117號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 10 | 痱子傷口護(hù)理軟膏 | 國械備20191324號(hào) | LABORATOIRES FANNAMEX | 68 Rue du Faubourg Saint Honoré 75008 PARIS FRANCE | 2025-06-30 |
| 11 | 淚道探針 | 國械備20250189號(hào) | MORIA S. A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-30 |
| 12 | 基礎(chǔ)外科手術(shù)器械 | 國械備20250188號(hào) | Beauty Teck International (Pvt)Ltd | Head Marala Road, Machi Khokar, Sialkot 51310,Pakistan | 2025-06-27 |
| 13 | DAB顯色增強(qiáng)液 | 國械備20250187號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom | 2025-06-27 |
| 14 | 免疫顯色試劑 | 國械備20250186號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom | 2025-06-27 |
| 15 | CD79a抗體試劑 | 國械備20250185號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom | 2025-06-27 |
| 16 | 造口袋 | 國械備20190594號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic; Priemyselny Park 3 07101 Michalovce Slovakia. | 2025-06-27 |
| 17 | 造口袋 | 國械備20210168號(hào) | ConvaTec Limited | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2025-06-27 |
| 18 | 肩關(guān)節(jié)手術(shù)工具 | 國械備20151656號(hào) | DePuy(Ireland) | Loughbeg, Ringaskiddy, Co.Cork, Ireland | 2025-06-27 |
| 19 | 種植輔助材料 | 國械備20190760號(hào) | MEDENTiKA GmbH | Hammweg 8-10 76549 Hügelsheim Germany | 2025-06-27 |
| 20 | 種植體掃描體 | 國械備20190664號(hào) | MEDENTiKA GmbH | Hammweg 8-10 76549 Hügelsheim Germany | 2025-06-27 |
| 21 | 吸引頭 | 國械備20161923號(hào) | Hu-Friedy Mfg. Co., LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-27 |
| 22 | 牙科種植手術(shù)器械包 | 國械備20250184號(hào) | Dentium Co., Ltd. | 76(3F,4F(Part),6F), Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea | 2025-06-26 |
| 23 | 顯微眼用淚道擴(kuò)張器 | 國械備20250183號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 24 | 牙科工具包 | 國械備20220480號(hào) | TALLADIUM ESPA?A, S.L. | C/ Virginia Woolf, 17 - 25005 LLEIDA, Spain | 2025-06-25 |
| 25 | 眼用測(cè)量器 | 國械備20250182號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 26 | 前房注入器 | 國械備20250181號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 27 | 牙科開口器 | 國械備20210094號(hào) | Ultradent Products, Inc. | 505 West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA | 2025-06-25 |
| 28 | 眼用剪 | 國械備20250180號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 29 | 顯微眼用持針鉗 | 國械備20250179號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 30 | 口腔科手術(shù)器械 | 國械備20240280號(hào) | Secure Dental Company | Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot-51310-Pakistan | 2025-06-25 |
| 31 | 顯微眼用剪 | 國械備20250178號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 32 | 開瞼器 | 國械備20250177號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-25 |
| 33 | 二件式造口袋 | 國械備20190784號(hào) | Coloplast A/S | Coloplast Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary | 2025-06-24 |
| 34 | 造口護(hù)理用品附件 | 國械備20191252號(hào) | Coloplast A/S | Búzavirág út 15, 2800 Tatabánya, Hungary | 2025-06-24 |
| 35 | 造口栓 | 國械備20181572號(hào) | Coloplast A/S | Coloplast Hungary KFT, Coloplast utca 2, 4300 Nyírbátor, Hungary | 2025-06-24 |
| 36 | 手術(shù)輔助照明燈 | 國械備20250176號(hào) | DENTIS CO.,LTD. | 6, Yuram-ro, Dong-gu, Daegu 41065 South Korca | 2025-06-24 |
| 37 | 全自動(dòng)樣本處理系統(tǒng) | 國械備20250175號(hào) | SEBIA | Parc Technologique Léonard de Vinci, CP 8010 Lisses- 91008 EVRY CEDEX FRANCE | 2025-06-24 |
| 38 | 醫(yī)用外固定支具 | 國械備20171160號(hào) | DJO,LLC | Carretera Libre Tijuana Tecate # 20230 Submetropoli El Florido, Tijuana B.C. Mexico 22244 | 2025-06-23 |
| 39 | 金胺O染色液 | 國械備20250174號(hào) | Dagatronics Corporation | 117, Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do,10233，Korea | 2025-06-23 |
| 40 | 抗酸染色液 | 國械備20250173號(hào) | Dagatronics Corporation | 117, Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 10233, Korea | 2025-06-23 |
| 41 | 革蘭染色液 | 國械備20250172號(hào) | Dagatronics Corporation | 117, Tanjung-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 10233, Korea | 2025-06-23 |
| 42 | 蘇木素染色液 | 國械備20250171號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2025-06-20 |
| 43 | 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 | 2025-06-20 |
| 44 | 亮綠－過碘酸雪夫氏染色液 | 國械備20250169號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2025-06-20 |
| 45 | 阿利辛藍(lán)染色液 | 國械備20250168號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson AZ 85755, USA | 2025-06-20 |
| 46 | Tyrosinase抗體試劑（免疫組織化學(xué)） | 國械備20180628號(hào) | Ventana Medical Systems, Inc. | 1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA | 2025-06-20 |
| 47 | EMA抗體試劑（免疫組織化學(xué)） | 國械備20180447號(hào) | Ventana Medical Systems, Inc. | 1910 East Innovation Park Drive, Tucson, AZ, 85755, United States | 2025-06-20 |
| 48 | 代型材料 | 國械備20160324號(hào) | Osstem Implant Co., Ltd. | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002, Republic of Korea; 66-48, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002, Republic of Korea | 2025-06-20 |
| 49 | 口腔開口器 | 國械備20160658號(hào) | Hu-Friedy Mfg.Co.,LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-20 |
| 50 | 牙用尺 | 國械備20160190號(hào) | Hu-Friedy Mfg.Co.,LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-20 |
| 51 | 眼用刮匙 | 國械備20250167號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-19 |
| 52 | 顯微眼用鑷 | 國械備20250166號(hào) | MORIA S.A | 27 rue du Pied de Fourche 03160 Bourbon L’Archambault FRANCE | 2025-06-19 |
| 53 | 牙科拋光條 | 國械備20250165號(hào) | DS DENTASONIC SA | Via Piodella 12,CH-6933 Muzzano | 2025-06-19 |
| 54 | 牙科工具 | 國械備20250003號(hào) | TruAbutment Korea Co., Ltd. | 104-214~216, 101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do,14449, Rep. of Korea | 2025-06-19 |
| 55 | 牙科工具包 | 國械備20250002號(hào) | TruAbutment Korea Co., Ltd. | 104-214~216, 101-1308~1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do,14449, Rep. of Korea | 2025-06-19 |
| 56 | 醫(yī)用檢查手套 | 國械備20250164號(hào) | Supermax Glove Manufacturing Sdn. Bhd. | Lot 42, Putra Industrial Park, Bukit Rahman Putra, 40160 Sungai Buloh, Selangor Darul Ehsan, Malaysia | 2025-06-19 |
| 57 | 檢查手套 | 國械備20190584號(hào) | Mexpo International Inc. | Lot 5091,Jalan Teratai, Batu 5, Off Jalan Meru,41050 Klang,Selangor Darul Ehsan, Malaysia | 2025-06-17 |
| 58 | 造口底盤 | 國械備20181394號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2025-06-16 |
| 59 | 骨科手術(shù)器械 | 國械備20250163號(hào) | HEXAMED（PRIVATE）LIMITED | Barlas Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan. | 2025-06-13 |
| 60 | 基礎(chǔ)外科手術(shù)器械 | 國械備20250162號(hào) | HEXAMED（PRIVATE）LIMITED | Barlas Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan. | 2025-06-13 |
| 61 | 乳腺加壓彈力繃帶 | 國械備20170004號(hào) | Amoena Medizin-Orthop?die-Technik GmbH | Kapellenweg 36 83064 Raubling Germany | 2025-06-13 |
| 62 | 成形片 | 國械備20210215號(hào) | Ultradent Products, Inc. | 505 West Ultradent Drive (10200 South) ,South Jordan, Utah 84095, USA | 2025-06-13 |
| 63 | 腰部固定器 | 國械備20250161號(hào) | SPORLASTIC GmbH & Co. KG | Weberstra?e 1, 72622 Nürtingen, Germany | 2025-06-12 |
| 64 | 膝關(guān)節(jié)固定器 | 國械備20250160號(hào) | SPORLASTIC GmbH & Co. KG | Weberstra?e 1, 72622 Nürtingen, Germany | 2025-06-12 |
| 65 | 膝部固定器 | 國械備20250159號(hào) | SPORLASTIC GmbH & Co. KG | Weberstra?e 1, 72622 Nürtingen, Germany | 2025-06-12 |
| 66 | 牙骨錘 | 國械備20161789號(hào) | Hu-Friedy Mfg. Co., LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-11 |
| 67 | 牙用手術(shù)刀 | 國械備20161103號(hào) | Hu-Friedy Mfg. Co., LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-11 |
| 68 | 脊柱牽開器 | 國械備20190782號(hào) | Starmed Engineering (Pvt) Ltd. | 191, Khadim Ali Road, Sialkot-Pakistan | 2025-06-10 |
| 69 | 脊柱用手術(shù)工具 | 國械備20161250號(hào) | Medtronic Sofamor Danek USA, Inc. | Werftstr. 17, 94469 Deggendorf, Germany；4340 Swinnea Road, Memphis, TN 38118, USA | 2025-06-09 |
| 70 | 引流袋 | 國械備20150058號(hào) | 怡安醫(yī)療器材股份有限公司 | 苗栗縣竹南鎮(zhèn)新南里7鄰三角店二十八之二號(hào) | 2025-06-09 |
| 71 | 造口袋 | 國械備20240027號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. Priemyselny Park 3 07101 Michalovce Slovakia | 2025-06-09 |
| 72 | 造口袋 | 國械備20210169號(hào) | ConvaTec Limited | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2025-06-09 |
| 73 | 造口袋 | 國械備20190171號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2025-06-09 |
| 74 | 造口袋 | 國械備20181323號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2025-06-09 |
| 75 | 核酸分析用病毒裂解試劑 | 國械備20160251號(hào) | Roche Molecular Systems, Inc. | 1080 US Highway 202 South, Branchburg, NJ 08876, USA | 2025-06-09 |
| 76 | 帶固定板的頸椎融合器手術(shù)工具 | 國械備20170867號(hào) | Bricon GmbH | Villingerstr. 33 78166 Donaueschingen Germany | 2025-06-06 |
| 77 | 冷凍切片機(jī) | 國械備20161064號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19 69226 Nussloch Germany | 2025-06-06 |
| 78 | 冷凍切片機(jī) | 國械備20180127號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19, 69226 Nussloch, Germany | 2025-06-06 |
| 79 | 冷凍切片機(jī) | 國械備20161066號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19 69226 Nussloch Germany | 2025-06-06 |
| 80 | 基礎(chǔ)外科手術(shù)器械 | 國械備20250158號(hào) | Surtex Instruments Ltd. | Kingspark Business Centre, Unit 202, 152-178 Kingston Road, New Malden, KT3 3ST Great Britain. | 2025-06-06 |
| 81 | 醫(yī)用檢查手套 | 國械備20250157號(hào) | Hartalega NGc Sdn. Bhd. | No.1, Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor Darul Ehsan MALAYSIA | 2025-06-05 |
| 82 | 超聲探頭穿刺架 | 國械備20250037號(hào) | ELESTA S.P.A. | Via Arsiero Salvanti, 41/43-50041 Calenzano (FI) - Italy | 2025-06-05 |
| 83 | 核酸提取或純化試劑 | 國械備20170757號(hào) | 臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司 | 桃園縣桃園市龍山里龍壽街81巷12弄2號(hào) | 2025-06-05 |
| 84 | 核酸提取試劑 | 國械備20210579號(hào) | 臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司 | 桃園市桃園區(qū)龍山里龍壽街 81 巷 12 弄 2 號(hào) | 2025-06-05 |
| 85 | 核酸提取試劑 | 國械備20210577號(hào) | 臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司 | 桃園市桃園區(qū)龍山里龍壽街 81 巷 12 弄 2 號(hào) | 2025-06-05 |
| 86 | 全自動(dòng)核酸提取儀 | 國械備20151812號(hào) | 臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司 | 臺(tái)灣桃園市桃園區(qū)龍山里龍壽街81巷12弄2號(hào) | 2025-06-05 |
| 87 | 口鏡 | 國械備20250156號(hào) | 賈雷格斯實(shí)業(yè)有限公司 | 臺(tái)中市潭子區(qū)豐栗路100巷88弄8號(hào) | 2025-06-05 |
| 88 | 牙用輸送器 | 國械備20161102號(hào) | Hu-Friedy Mfg. Co.,LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-04 |
| 89 | 唇頰牽開器 | 國械備20160659號(hào) | Hu-Friedy Mfg.Co.,LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-06-04 |
| 90 | 腰椎融合器手術(shù)工具 | 國械備20170101號(hào) | Bricon GmbH | Wasserkuppenstrasse 29-31 - 36043 Fulda Germany | 2025-06-03 |
| 91 | 椎板固定板系統(tǒng)手術(shù)工具 | 國械備20220080號(hào) | Bricon GmbH | Eisenbahnstrasse 100 78573 Wurmlingen Germany | 2025-06-03 |
| 92 | 頸椎前路固定板系統(tǒng)手術(shù)工具 | 國械備20170832號(hào) | Bricon GmbH | Villingerstr. 33 78166 Donaueschingen Germany | 2025-06-03 |
| 93 | 脊柱后路內(nèi)固定系統(tǒng)手術(shù)工具 | 國械備20170833號(hào) | bricon GmbH | Villingerstr. 33 78166 Donaueschingen Germany | 2025-06-03 |
| 94 | 咬骨鉗 | 國械備20171018號(hào) | bricon GmbH | Villingerstr. 33 78166 Donaueschingen Germany | 2025-06-03 |
| 95 | 脊柱后路內(nèi)固定系統(tǒng)手術(shù)工具 | 國械備20190313號(hào) | Bricon GmbH | Villingerstr. 33 78166 Donaueschingen Germany | 2025-06-03 |
| 96 | 持瓣器 | 國械備20240185號(hào) | Edwards Lifesciences LLC | One Edwards Way Irvine, CA USA 92614 | 2025-06-03 |
| 97 | 醫(yī)用轉(zhuǎn)移板 | 國械備20250155號(hào) | MAQUET GmbH | Kehler Straβe 31, 76437 Rastatt, GERMANY | 2025-06-03 |
| 98 | 手術(shù)頭架 | 國械備20250154號(hào) | MAQUET GmbH | Kehler Straβe 31, 76437 Rastatt, GERMANY | 2025-06-03 |
| 99 | 膝關(guān)節(jié)支撐架 | 國械備20250153號(hào) | MAQUET GmbH | Kehler Straβe 31, 76437 Rastatt, GERMANY | 2025-06-03 |
| 100 | 醫(yī)用支撐腿架 | 國械備20250152號(hào) | MAQUET GmbH | Kehler Straβe 31, 76437 Rastatt, GERMANY | 2025-06-03 |
| 101 | 托手架 | 國械備20250151號(hào) | MAQUET GmbH | Kehler Straβe 31, 76437 Rastatt, GERMANY | 2025-06-03 |
| 102 | 血細(xì)胞分析儀用溶血?jiǎng)?/td> | 國械備20160699號(hào) | BOULE MEDICAL AB | Domnarvsgatan 4, SE-163 53 Spanga, Sweden | 2025-06-03 |
| 103 | 血細(xì)胞分析儀用溶血?jiǎng)?/td> | 國械備20151347號(hào) | BOULE MEDICAL AB | Domnarvsgatan 4, SE-163 53 Spanga, Sweden | 2025-06-03 |
| 104 | 血細(xì)胞分析儀用稀釋液 | 國械備20160700號(hào) | BOULE MEDICAL AB | Domnarvsgatan 4, SE-163 53 Spanga, Sweden | 2025-06-03 |
| 105 | 血細(xì)胞分析用稀釋液 | 國械備20151346號(hào) | Boule Medical AB | Domnarvsgatan 4, SE-163 53 Sp?nga, Sweden | 2025-06-03 |