| 2023年2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 | 腕部固定系統(tǒng)手術(shù)器械 | 國(guó)械備20200202號(hào) | TriMed, Inc. | 27533 Avenue Hopkins, Santa Clarita, CA 91355, USA | 2023-02-28 | 變更 |
| 2 | 研光器 | 國(guó)械備20230127號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 3 | 橡皮障支架 | 國(guó)械備20230126號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 4 | 銀汞合金輸送器 | 國(guó)械備20230125號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 5 | 牙科用軟組織環(huán)切刀 | 國(guó)械備20230124號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 6 | 牙骨銼 | 國(guó)械備20230123號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 7 | 橡皮障夾鉗 | 國(guó)械備20230122號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 8 | 橡皮障打孔器 | 國(guó)械備20230121號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-28 | 有效 |
| 9 | 成形片 | 國(guó)械備20170117號(hào) | Kerr Corporation | Via Strecce 4 P.O. 272 6934 Bioggio Switzerland | 2023-02-28 | 變更 |
| 10 | 人工肩關(guān)節(jié)系統(tǒng)手術(shù)器械包 | 國(guó)械備20230120號(hào) | Tornier SAS | 161 Rue Lavoisier, 38330 Montbonnot-Saint-Martin, FRANCE | 2023-02-27 | 有效 |
| 11 | 口腔科器械 | 國(guó)械備20191336號(hào) | A.Schweickhardt GmbH＆Co.KG | Tuttlinger Straße 12 78606 Seitingen / Tuttlingen Germany | 2023-02-27 | 變更 |
| 12 | 牙用充填器 | 國(guó)械備20230119號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-24 | 有效 |
| 13 | 牙科骨磨 | 國(guó)械備20230118號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-24 | 有效 |
| 14 | 牙用尺 | 國(guó)械備20230117號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-24 | 有效 |
| 15 | 牙科輸送器 | 國(guó)械備20230116號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-24 | 有效 |
| 16 | 牙科刮治器 | 國(guó)械備20161891 號(hào) | 株式會(huì)社YDM | 埼玉県東松山市今泉28番地 | 2023-02-24 | 變更 |
| 17 | 印模轉(zhuǎn)移桿 | 國(guó)械備20190965號(hào) | SHINHUNG MST CO., LTD. | 110-2，Donghwagongdan-ro，Munmak-eup，Wonju-si，Gangwon-do，26365，Rep. of KOREA | 2023-02-24 | 變更 |
| 18 | 正畸鉗 | 國(guó)械備20161162號(hào) | 株式會(huì)社YDM | 埼玉県東松山市今泉28番地 | 2023-02-24 | 變更 |
| 19 | 口腔麻醉手動(dòng)注射架 | 國(guó)械備20230115號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-24 | 有效 |
| 20 | 牙科骨粉調(diào)和用金屬容器 | 國(guó)械備20230114號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-24 | 有效 |
| 21 | EMA抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230113號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-23 | 有效 |
| 22 | bcl-2抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230112號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-23 | 有效 |
| 23 | Ber-EP4抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230111號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-23 | 有效 |
| 24 | 檢查手套 | 國(guó)械備20181354號(hào) | B. Braun Melsungen AG | Latexx Partners Berhad, Lot 18374, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting, Taiping, Perak, Malaysia | 2023-02-23 | 無(wú)效 |
| 25 | 牙科種植用延長(zhǎng)器 | 國(guó)械備20161072號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 26 | 試戴體 | 國(guó)械備20161046號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 27 | 牙科骨擠壓器 | 國(guó)械備20160935號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 28 | 牙用尺 | 國(guó)械備20160516號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center Birmingham Alabama 35244 USA | 2023-02-23 | 變更 |
| 29 | 螺絲起 | 國(guó)械備20161071號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 30 | 基臺(tái)適配器 | 國(guó)械備20170668號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 31 | 種植體內(nèi)螺紋修復(fù)器 | 國(guó)械備20161080號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 32 | 牙科用銼 | 國(guó)械備20161073號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 33 | 轉(zhuǎn)移帽 | 國(guó)械備20161082號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama 35244 USA | 2023-02-23 | 變更 |
| 34 | 種植體旋入止停器 | 國(guó)械備20190692號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama, 35244 USA | 2023-02-23 | 變更 |
| 35 | 替代體 | 國(guó)械備20190775號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center, Birmingham, Alabama, 35244 USA | 2023-02-23 | 變更 |
| 36 | 基臺(tái)夾持器 | 國(guó)械備20191276號(hào) | BioHorizons Implant Systems, Inc. | 2300 Riverchase Center Birmingham Alabama, 35244 USA | 2023-02-23 | 變更 |
| 37 | Ber-EP4抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230110號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-23 | 有效 |
| 38 | ERG抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230109號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-23 | 有效 |
| 39 | 醫(yī)用外固定支具 | 國(guó)械備20230108號(hào) | DJO，LLC | No.143, Sec.2, Zhangxin Rd., Hemei Township, Changhua County 50854, Taiwan (R.O.C.) | 2023-02-23 | 有效 |
| 40 | 導(dǎo)航定位系統(tǒng)工具 | 國(guó)械備20230078號(hào) | Medtronic Navigation, Inc. | 826 Coal Creek Circle Louisville, CO 80027 United States of America | 2023-02-23 | 變更 |
| 41 | CD21抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230107號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-22 | 有效 |
| 42 | 巨細(xì)胞病毒抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230106號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-22 | 有效 |
| 43 | 巨細(xì)胞病毒抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230105號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-22 | 有效 |
| 44 | CD7抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230104號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-22 | 有效 |
| 45 | bcl-6抗體試劑（免疫組織化學(xué)） | 國(guó)械備20230103號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42 DK-2600 Glostrup DENMARK | 2023-02-22 | 有效 |
| 46 | 牙科種植材料取出器 | 國(guó)械備20151824號(hào) | Nobel Biocare AB | Dimbovägen 2 SE-691 51 Karlskoga Sweden；22715 Savi Ranch Parkway Yorba Linda California 92887 USA；Engvej 33, 3330 Gørløse, Denmark；74950 SCIONZIER France；Trophagener Weg 25, 32657 Lemgo Deutschland；3233 W. Harvard Street, Santa Ana, California, 92704,USA | 2023-02-22 | 變更 |
| 47 | 牙科用軟組織環(huán)切刀 | 國(guó)械備20151961號(hào) | Nobel Biocare AB | Dimbovagen 2 SE-691 51 Karlskoga Sweden；22715 Savi Ranch Parkway Yorba Linda California 92887 USA；Engvej 33, 3330 Gørløse, Denmark；3233 W. Harvard Street, Santa Ana, California, 92704,USA | 2023-02-22 | 變更 |
| 48 | 牙科器械鉗 | 國(guó)械備20230102號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-22 | 有效 |
| 49 | 截石位手術(shù)體位固定架 | 國(guó)械備20160606號(hào) | ALLEN MEDICAL SYSTEMS,INC. | 100 Discovery Way Acton,MA 01720 | 2023-02-22 | 變更 |
| 50 | 牙科用鑷 | 國(guó)械備20230101號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-22 | 有效 |
| 51 | 牙科用剪 | 國(guó)械備20230100號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-22 | 有效 |
| 52 | 硅橡膠復(fù)制材料包 | 國(guó)械備20210231號(hào) | DETAX GmbH | Carl-Zeiss-Straβe 4, 76275 Ettlingen, Germany | 2023-02-22 | 變更 |
| 53 | X射線膠片顯影液 | 國(guó)械備20230099號(hào) | Carestream Health,Inc. | 1049 West Ridge Road，Rochester, NY USA 14615 | 2023-02-22 | 有效 |
| 54 | X射線膠片顯影液和定影液 | 國(guó)械備20230098號(hào) | Caretsream Health,Inc. | 1049 West Ridge Road,Rochester,NY USA 14615 | 2023-02-22 | 有效 |
| 55 | X射線膠片定影液 | 國(guó)械備20230097號(hào) | Carestream Health,Inc. | 1049 West Ridge Road，Rochester, NY USA 14615 | 2023-02-22 | 有效 |
| 56 | 拔牙鉗 | 國(guó)械備20230096號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-22 | 有效 |
| 57 | 牙科用牽開(kāi)器 | 國(guó)械備20230095號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-22 | 有效 |
| 58 | 牙科用刀 | 國(guó)械備20230094號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-22 | 有效 |
| 59 | 硅橡膠復(fù)制材料 | 國(guó)械備20190650號(hào) | DETAX GmbH | Carl-Zeiss-Straβe 4, 76275 Ettlingen, Germany | 2023-02-21 | 變更 |
| 60 | 模型樹(shù)脂包 | 國(guó)械備20190744號(hào) | DETAX GmbH | Carl-Zeiss-Straβe 4, 76275 Ettlingen, Germany | 2023-02-21 | 變更 |
| 61 | 微生物比濁儀 | 國(guó)械備20230093號(hào) | Beckman Coulter, Inc. | 25 Bradley Drive, Westbrook, Maine 04092, USA | 2023-02-21 | 有效 |
| 62 | 自粘彈力繃帶 | 國(guó)械備20161076號(hào) | 3M Company | 601 22nd Ave. South Brookings, South Dakota, 57006, USA | 2023-02-21 | 變更 |
| 63 | 自粘彈力繃帶 | 國(guó)械備20150894號(hào) | 3M Company | 3M Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA | 2023-02-21 | 變更 |
| 64 | 醫(yī)用退熱凝膠 | 國(guó)械備20210308號(hào) | SACRUM ALGAE株式會(huì)社 | 東京都足立區(qū)梅田六丁目9番6號(hào) | 2023-02-21 | 變更 |
| 65 | 人體定位墊 | 國(guó)械備20230092號(hào) | Philips Medical Systems Nederland B.V. | Veenpluis 6, 5684 PC Best, The Netherlands | 2023-02-21 | 有效 |
| 66 | 非接觸裂隙燈前置鏡 | 國(guó)械備20210237號(hào) | VOLK OPTICAL INC. | 7893 ENTERPRISE DR. Mentor, OH USA 44060 | 2023-02-21 | 變更 |
| 67 | 種植體清潔刷 | 國(guó)械備20200167號(hào) | 光弘生醫(yī)科技股份有限公司 | 桃園市蘆竹區(qū)內(nèi)厝里大豐街21號(hào) | 2023-02-20 | 變更 |
| 68 | 創(chuàng)傷手術(shù)器械包 | 國(guó)械備20151190號(hào) | Zimmer Switzerland Manufacturing GmbH | Sulzerallee 8, Winterthur, 8404, Switzerland | 2023-02-20 | 變更 |
| 69 | 肱骨髓內(nèi)釘手術(shù)工具 | 國(guó)械備20210174號(hào) | Zimmer Switzerland Manufacturing GmbH | Sulzerallee 8, Winterthur 8404 Switzerland | 2023-02-20 | 變更 |
| 70 | 手術(shù)托架 | 國(guó)械備20220036號(hào) | ミズホ株式會(huì)社 | 新潟県五泉市赤海3631番14，千葉県佐倉(cāng)市太田2173番地13 | 2023-02-17 | 變更 |
| 71 | 腹腔用拉鉤裝置器 | 國(guó)械備20160311號(hào) | Max Hauser Süddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33，78532 Tuttlingen Germany | 2023-02-17 | 變更 |
| 72 | 牙科骨磨 | 國(guó)械備20230091號(hào) | A.Schweickhardt GmbH & Co.KG | Tuttlinger Straße 12 78606 Seitingen/ Tuttlingen Germany | 2023-02-17 | 有效 |
| 73 | 注射器輔助推進(jìn)槍 | 國(guó)械備20230090號(hào) | Owen Mumford Limited | Primsdown Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire,OX7 5XP, United Kingdom | 2023-02-17 | 有效 |
| 74 | 藥敏接種培養(yǎng)液 | 國(guó)械備20230089號(hào) | Remel, Inc | 12076 Santa Fe Trail Drive Lenexa Kansas 66215 USA | 2023-02-16 | 有效 |
| 75 | 肉湯培養(yǎng)基 | 國(guó)械備20230088號(hào) | Remel, Inc | 12076 Santa Fe Trail Drive Lenexa Kansas 66215 USA | 2023-02-16 | 有效 |
| 76 | 清洗液 | 國(guó)械備 20170375號(hào) | EKF-diagnostic GmbH | Ebendorfer Chaussee 3, 39179 Barleben, GERMANY | 2023-02-16 | 變更 |
| 77 | 樣本稀釋液 | 國(guó)械備20150741號(hào) | Wallac Oy | Mustionkatu 6, FI-20750 Turku, Finland | 2023-02-16 | 無(wú)效 |
| 78 | 上肢醫(yī)用外固定支具 | 國(guó)械備20170269號(hào) | Össur hf. | Grjotháls 1-5 Reykjavik 110 Iceland | 2023-02-15 | 變更 |
| 79 | 糞便檢驗(yàn)預(yù)處理裝置 | 國(guó)械備20151619號(hào) | EIKEN CHEMICAL CO., LTD. | 3585, Kando, Yoshida-cho, Haibara-gun, Shizuoka, 421-0304 JAPAN | 2023-02-15 | 變更 |
| 80 | 骨科手術(shù)器械 | 國(guó)械備20191138號(hào) | Limacorporate S.p.A. | Via Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY | 2023-02-15 | 變更 |
| 81 | 醫(yī)用檢查手套 | 國(guó)械備20230087號(hào) | UG GLOBAL RESOURCES SDN. BHD. | Lot 62 & 63, Lorong Senawang 3/2,Kawasan Perindustrian Senawang, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia | 2023-02-15 | 有效 |
| 82 | 醫(yī)用支撐腿架 | 國(guó)械備20230086號(hào) | MAQUET GmbH | Kehler Straβe 31, 76437 Rastatt, Germany | 2023-02-14 | 有效 |
| 83 | 手術(shù)剪 | 國(guó)械備20230085號(hào) | Berger Surgical Medical Products GmbH | Take-off-Gewerbepark 4 D-78579 Neuhausen ob Eck | 2023-02-14 | 有效 |
| 84 | 肛門鏡 | 國(guó)械備20230084號(hào) | Berger Surgical Medical Products GmbH | Take-off-Gewerbepark 4 D-78579 Neuhausen ob Eck | 2023-02-14 | 有效 |
| 85 | 外耳道擴(kuò)張器 | 國(guó)械備20230083號(hào) | Berger Surgical Medical Products GmbH | Take-off-Gewerbepark 4 D-78579 Neuhausen ob Eck | 2023-02-14 | 有效 |
| 86 | 壓板 | 國(guó)械備20230082號(hào) | Berger Surgical Medical Products GmbH | Take-off-Gewerbepark 4 D-78579 Neuhausen ob Eck | 2023-02-14 | 有效 |
| 87 | 種植輔助器械包 | 國(guó)械備20180112號(hào) | ALTATEC GmbH | Maybachstr. 5,71299 Wimsheim, Germany | 2023-02-13 | 變更 |
| 88 | 牙科模型材料 | 國(guó)械備20161677號(hào) | ALTATEC GmbH | Maybachstr.5, 71299 Wimsheim, GERMANY | 2023-02-13 | 變更 |
| 89 | 轉(zhuǎn)移帽 | 國(guó)械備20180208號(hào) | ALTATEC GmbH | Maybachstr. 5,71299 Wimsheim, Germany | 2023-02-13 | 變更 |
| 90 | 種植體安裝輔助器械 | 國(guó)械備20190350號(hào) | ALTATEC GmbH | Maybachstr. 5, 71299 Wimsheim, GERMANY | 2023-02-13 | 變更 |
| 91 | 種植體安裝輔助器械 | 國(guó)械備20180987號(hào) | ALTATEC GmbH | Maybachstr. 5, 71299 Wimsheim, Germany | 2023-02-13 | 變更 |
| 92 | 牙科種植輔助器械包 | 國(guó)械備20180988號(hào) | ALTATEC GmbH | Maybachstr. 5, 71299 Wimsheim, Germany | 2023-02-13 | 變更 |
| 93 | 種植輔助材料 | 國(guó)械備20181551號(hào) | ALTATEC GmbH | Maybachstr. 5, 71299 Wimsheim, GERMANY | 2023-02-13 | 變更 |
| 94 | 牙科骨擠壓器 | 國(guó)械備20170960號(hào) | ALTATEC GmbH | Maybachstr. 5,71299 Wimsheim, Germany | 2023-02-13 | 變更 |
| 95 | 夾板及固定帶 | 國(guó)械備20190059號(hào) | VARİTEKS ORTOPEDİ SANAYİ A.Ş. | Maltepe Mah, Aile Bahçe Sok., Litros Yolu, No: 10, 34010, Zeytinburnu, İstanbul, Turkey | 2023-02-13 | 變更 |
| 96 | 踝部固定器 | 國(guó)械備20230081號(hào) | PAVIS S.P.A. | Via G.Rossini, 11/B - 21020 Buguggiate (VA), Italy | 2023-02-10 | 有效 |
| 97 | 麥?zhǔn)媳葷嵊?jì) | 國(guó)械備20220077號(hào) | Trek Diagnostic Systems Ltd | Viking House Ellingham Way Ashford TN23 6NF United Kingdom | 2023-02-10 | 變更 |
| 98 | 髖關(guān)節(jié)手術(shù)器械 | 國(guó)械備20151787號(hào) | Smith & Nephew,Inc |
1450
Brooks Road, Memphis, Tennessee, 38116, USA； Alemannenstraβe 14, D-78532, Tuttlingen, 78532, Germany; 2 lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, 11920 Bayan Lepas, Penang, MALAYSIA; Schachenallee 29, 5001 Aarau, SWITZERLAND; Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C. 22444, Mexico. |
2023-02-09 | 變更 |
| 99 | 小骨關(guān)節(jié)植入物手術(shù)器械包 | 國(guó)械備20160867號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 100 | 空心加壓螺釘系統(tǒng)手術(shù)器械包 | 國(guó)械備20160475號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 101 | 足踝系統(tǒng)用手術(shù)器械包 | 國(guó)械備20161099號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 102 | 骨折固定系統(tǒng)手術(shù)器械包 | 國(guó)械備20160931號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 103 | 足踝釘板系統(tǒng)用手術(shù)器械包 | 國(guó)械備20191102號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 104 | 模型樹(shù)脂 | 國(guó)械備20180695號(hào) | VERICOM CO., LTD | 48，Toegyegongdan 1-gil，Chuncheon-si, Gangwon-do, 200-944,Republic of KOREA | 2023-02-09 | 變更 |
| 105 | 骨鉸刀 | 國(guó)械備20191045號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 106 | 足踝釘板系統(tǒng)手術(shù)器械包 | 國(guó)械備20190267號(hào) | Wright Medical Technology, Inc | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 107 | 足踝髓內(nèi)釘系統(tǒng)手術(shù)器械包 | 國(guó)械備20161201號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 108 | 全踝關(guān)節(jié)手術(shù)器械包 | 國(guó)械備20161100號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 109 | 壓力繃帶 | 國(guó)械備20230080號(hào) | SIGVARIS Inc. | 13055 Riley St., Suite 30 Holland, Michigan 49424 USA | 2023-02-09 | 有效 |
| 110 | 肘關(guān)節(jié)手術(shù)器械包 | 國(guó)械備20160724號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 111 | 壓力繃帶 | 國(guó)械備20230079號(hào) | SIGVARIS Inc. | 13055 Riley St., Suite 30 Holland, Michigan 49424 USA | 2023-02-09 | 有效 |
| 112 | 全踝關(guān)節(jié)手術(shù)器械包 | 國(guó)械備20191444號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 113 | 骨鉸刀 | 國(guó)械備20191100號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 114 | 全踝關(guān)節(jié)手術(shù)器械包 | 國(guó)械備20200188號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 115 | 骨科定位片 | 國(guó)械備20191061號(hào) | Wright Medical Technology, Inc. | 11576 Memphis Arlington Road, Arlington, Tennessee, 38002, USA | 2023-02-09 | 變更 |
| 116 | 導(dǎo)航定位系統(tǒng)工具 | 國(guó)械備20230078號(hào) | Medtronic Navigation, Inc. | 826 Coal Creek Circle Louisville, CO 80027 United States of America | 2023-02-09 | 有效 |
| 117 | 超聲探頭穿刺架 | 國(guó)械備20230077號(hào) | GE ヘルスケア・ジャパン株式會(huì)社 | 〒191-8503 東京都日野市旭が丘 4-7-127 | 2023-02-08 | 有效 |
| 118 | 牙科橡皮障楔線 | 國(guó)械備20160116號(hào) | Dent4You AG | 235 Ascot Parkway Cuyahoga Falls, OH 44223 United States of America | 2023-02-08 | 變更 |
| 119 | 骨科手術(shù)器械 | 國(guó)械備20191433號(hào) | Limacorporate S.p.A. | Via Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY | 2023-02-08 | 變更 |
| 120 | 骨科手術(shù)器械 | 國(guó)械備20200331號(hào) | HPF S.r.l. | Via Pinzano, 24 - 33030 Flagogna di Forgaria nel Friuli (UD) - Italy | 2023-02-08 | 變更 |
| 121 | 下肢醫(yī)用外固定支具 | 國(guó)械備20150418號(hào) | Breg Inc. | Calzada Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California, Mexico | 2023-02-08 | 變更 |
| 122 | 上肢醫(yī)用外固定支具 | 國(guó)械備20150417號(hào) | Breg Inc. | Calzada Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California, Mexico | 2023-02-08 | 變更 |
| 123 | 踝部固定器 | 國(guó)械備20180276號(hào) | Breg Inc | 見(jiàn)附件 | 2023-02-08 | 變更 |
| 124 | 醫(yī)用外固定支具 | 國(guó)械備20180274號(hào) | Breg Inc | Calzada Presidnte Venustiano Carrnza #33, C.p.21385, Mexicali, Baja California, Mexico. | 2023-02-08 | 變更 |
| 125 | 橡皮障支架 | 國(guó)械備20160478號(hào) | Dent4You AG | 235 Ascot Parkway Cuyahoga Falls OH 44223 United States Of America | 2023-02-07 | 變更 |
| 126 | 橡皮障打孔器 | 國(guó)械備20160375號(hào) | Dent4You AG | 235 Ascot Parkway Cuyahoga Falls OH 44223 United States Of America | 2023-02-07 | 變更 |
| 127 | 牙刮匙 | 國(guó)械備20230076號(hào) | ASA DENTAL SPA | VIA FIERLA 13-33085 MANIAGO (PN) | 2023-02-07 | 有效 |
| 128 | 醫(yī)用彈力貼布 | 國(guó)械備20191353號(hào) | ニチバン株式會(huì)社 | 日本福岡県朝倉(cāng)郡筑前町野町字禪門橋1713 | 2023-02-06 | 變更 |
| 129 | 婦產(chǎn)科手術(shù)器械 | 國(guó)械備20200043號(hào) | DELMONT IMAGING | 390 Avenue du Mistral, 13600 La Ciotat, France | 2023-02-06 | 變更 |
| 130 | 橡皮障夾鉗 | 國(guó)械備20160376號(hào) | Dent4You AG | 235 Ascot Parkway Cuyahoga Falls OH 44223 United States Of America | 2023-02-06 | 變更 |
| 131 | 橡皮障夾 | 國(guó)械備20151720號(hào) | Dent4You AG | 235 Ascot Parkway Cuyahoga Falls, OH 44223 United States of America | 2023-02-06 | 變更 |
| 132 | 口腔科手術(shù)器械 | 國(guó)械備20230075號(hào) | ASAS AND BROTHERS ENTERPRISES | MODEL TOWN,UGOKI,SIALKOT,PAKISTAN | 2023-02-06 | 有效 |
| 133 | 異硫氰酸熒光素(FITC)標(biāo)記的兔抗人C3c（含伊文氏蘭） | 國(guó)械備20200399號(hào) | EUROIMMUN Medizinische Labordiagnostika AG | Werkstraβe 1, 23942 Dassow, Germany | 2023-02-06 | 變更 |
| 134 | 異硫氰酸熒光素(FITC)標(biāo)記的羊抗人IgG（含碘化丙啶） | 國(guó)械備20200400號(hào) | EUROIMMUN Medizinische Labordiagnostika AG | Werkstraβe 1, 23942 Dassow, Germany | 2023-02-06 | 變更 |
| 135 | 異硫氰酸熒光素(FITC)標(biāo)記的羊抗人IgM（含伊文氏蘭） | 國(guó)械備20200398號(hào) | EUROIMMUN Medizinische Labordiagnostika AG | Werkstraβe 1, 23942 Dassow, Germany | 2023-02-06 | 變更 |
| 136 | 干式激光成像儀 | 國(guó)械備20151260號(hào) | コニカミノルタ株式會(huì)社 | 埼玉県狹山市広瀬臺(tái)二丁目2番1號(hào) 2-2-1， Hirosedai，Sayama-shi，Saitama | 2023-02-06 | 變更 |
| 137 | 干式激光成像儀 | 國(guó)械備20170398號(hào) | コニカミノルタ株式會(huì)社 | 1 Sakura-machi，Hino-shi，Tokyo，Japan；2-2-1， Hirosedai，Sayama-shi，Saitama，Japan | 2023-02-06 | 變更 |
| 138 | 醫(yī)用檢查手套 | 國(guó)械備20230074號(hào) | GLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD. | No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia. | 2023-02-06 | 有效 |
| 139 | 止血鉗 | 國(guó)械備20150031號(hào) | Max Hauser Süddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33，78532 Tuttlingen Germany | 2023-02-03 | 變更 |
| 140 | 超聲潔牙機(jī)工作尖 | 國(guó)械備20191244號(hào) | / | / | 2023-02-03 | 變更 |
| 141 | 醫(yī)用干式銀鹽膠片 | 國(guó)械備20230073號(hào) | AGFA NV | Septestraat 27, 2640 Mortsel , Belgium 1658 Bushy Park Road, Goose Creek, South Carolina 29445, USA | 2023-02-03 | 有效 |
| 142 | 高速冷凍離心機(jī) | 國(guó)械備20150368號(hào) | Thermo Electron LED GmbH Zweigniederlassung Osterode | Am Kalkberg, 37520 Osterode am Harz, Germany | 2023-02-03 | 變更 |
| 143 | 種植輔助材料 | 國(guó)械備20230072號(hào) | A.B. Dental Devices Ltd. | 19 Hayahalomim Street Ashdod 7761117 Israel | 2023-02-03 | 有效 |
| 144 | 藥敏接種培養(yǎng)液 | 國(guó)械備20140220號(hào) | Remel, Inc | 12076 Santa Fe Trail Drive , Lenexa, Kansas 66215, USA | 2023-02-02 | 變更 |
| 145 | 頭戴式放大鏡 | 國(guó)械備20162018號(hào) | Metrex Research LLC dba Orascoptic | 3225 Deming Way Suite 190 Middleton Wisconsin 53562 USA | 2023-02-02 | 變更 |
| 146 | CD36檢測(cè)試劑 | 國(guó)械備20230071號(hào) | BioLegend, Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-02-02 | 有效 |
| 147 | CD71檢測(cè)試劑 | 國(guó)械備20230070號(hào) | BioLegend, Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2023-02-02 | 有效 |
| 148 | 虹膜拉鉤 | 國(guó)械備20181048號(hào) | MICROSURGICAL TECHNOLOGY, INC. | 8415 154th Ave Ne Redmond, WA 98052 | 2023-02-02 | 變更 |
| 149 | 導(dǎo)引針 | 國(guó)械備20171015號(hào) | Boston Scientific Corporation | 10700 Bren Road West, Minnetonka, MN USA 55343 | 2023-02-01 | 變更 |
| 150 | 器械鉗 | 國(guó)械備20171065號(hào) | Boston Scientific Corporation | 10700 Bren Road West, Minnetonka, MN USA 55343 | 2023-02-01 | 變更 |
| 151 | 削切刀 | 國(guó)械備20151269號(hào) | Gebr. Brasseler GmbH & Co. KG | Trophagener Weg 25 32657 Lemgo Deutschland | 2023-02-01 | 無(wú)效 |
| 152 | 骨鉸刀 | 國(guó)械備20150482號(hào) | Gebr. Brasseler GmbH & Co. KG | Trophagener Weg 25 32657 Lemgo Deutschland | 2023-02-01 | 無(wú)效 |
| 153 | 鋸片 | 國(guó)械備20151270號(hào) | Gebr. Brasseler GmbH & Co. KG | Trophagener Weg 25 32657 Lemgo Deutschland | 2023-02-01 | 無(wú)效 |
| 154 | 一次性醫(yī)用丁腈橡膠手套 | 國(guó)械備20230069號(hào) | GLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD. | No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia. | 2023-02-01 | 有效 |
| 155 | 醫(yī)用檢查手套 | 國(guó)械備20230068號(hào) | GLOMAXES LATEX GLOVE MANUFACTURER SDN.BHD. | No.153,Jalan 4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul Ehsan,Malaysia. | 2023-02-01 | 有效 |
| 156 | 成像板暗盒 | 國(guó)械備20170460號(hào) | コニカミノルタ株式會(huì)社 | 日本國(guó)東京都日野市さくら町1番地；日本國(guó)埼玉県狹山市広瀬臺(tái)2-2-1 | 2023-02-27 | 無(wú)效 |
| 157 | 成像板暗盒 | 國(guó)械備20170461號(hào) | コニカミノルタ株式會(huì)社 | 日本國(guó)東京都日野市さくら町1番地；日本國(guó)埼玉県狹山市広瀬臺(tái)2-2-1 | 2023-02-27 | 無(wú)效 |
| 158 | 檢查手套 | 國(guó)械備20151388號(hào) | B. Braun Melsungen AG | 110 Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand | 2023-02-23 | 無(wú)效 |
來(lái)源：國(guó)家藥監(jiān)局 錄入時(shí)間：2023/3/14 16:45:00 點(diǎn)擊次數(shù)：622
實(shí)驗(yàn)室地址（濟(jì)南）：山東省濟(jì)南市高新區(qū)大正路1777號(hào)生物醫(yī)藥園中小企業(yè)產(chǎn)業(yè)化基地6號(hào)樓405
實(shí)驗(yàn)室地址（棗莊）：山東省棗莊市高新區(qū)新醫(yī)藥產(chǎn)業(yè)園三號(hào)樓二樓東側(cè)
Email：sdbangzhong@163.com
咨詢電話：0531-67984890
公司公眾號(hào)：邦眾檢測(cè)