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嘉峪檢測(cè)網(wǎng) 2025-06-17 17:31
2025年5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 | 腹部造口彈性繃帶 | 國(guó)械備20250150號(hào) |
Tytex A/S
|
Chemlonská 1,06601 Humenné, Slovakia | 2025-05-30 | 有效 |
| 2 | 喉鏡 | 國(guó)械備20250149號(hào) | HILBRO INTERNATIONAL (PVT) LTD. | 12 KM Daska Road, P.O. Box 250, Sialkot - Pakistan, | 2025-05-30 | 有效 |
| 3 | 醫(yī)用檢查手套 | 國(guó)械備20250148號(hào) | Supermax Glove Manufacturing Sdn. Bhd. | Lot 42, Putra Industrial Park, Bukit Rahman Putra, 40160 Sungai Buloh, Selangor Darul Ehsan, Malaysia | 2025-05-30 | 有效 |
| 4 | 膝關(guān)節(jié)固定器 | 國(guó)械備20170278號(hào) | Össur hf. | Grjotháls 1-5 Reykjavik 110 Iceland | 2025-05-30 | 變更 |
| 5 | 呼吸訓(xùn)練器 | 國(guó)械備20160866號(hào) | LEVENTON S.A.U. | BP 245 Z.I. Hammam-Zriba, 1152 Zaghouan, Tunisie | 2025-05-29 | 無(wú)效 |
| 6 | 放射治療患者用固定裝置 | 國(guó)械備20151105號(hào) | MACROMEDICS B.V. | Kouwe Hoek 18,2741 PX-Waddinxveen(The Netherlands) | 2025-05-29 | 變更 |
| 7 | 牙科種植掃描體 | 國(guó)械備20210008號(hào) | C-Tech Implant S.r.l. | Via Ravenna 382, 40018 San Pietro in Casale(BO), ITALY | 2025-05-28 | 變更 |
| 8 | 造口袋 | 國(guó)械備20210159號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2025-05-28 | 變更 |
| 9 | 造口底盤 | 國(guó)械備20200110號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2025-05-28 | 變更 |
| 10 | 造口袋 | 國(guó)械備20190016號(hào) | アルケア株式會(huì)社 | 千葉県千葉市花見川區(qū)千種町36-2 | 2025-05-28 | 變更 |
| 11 | 彈性醫(yī)用膠布 | 國(guó)械備20140098號(hào) | ァルケァ株式會(huì)社 | 289-4 Chigusa-Cho, Hanamigawa-Ku, Chiba-Shi, Chiba, Japan | 2025-05-28 | 變更 |
| 12 | 人體定位墊 | 國(guó)械備20240119號(hào) | ァルケァ株式會(huì)社 | 千葉県千葉市花見川區(qū)千種町 289-4 | 2025-05-28 | 變更 |
| 13 | 造口袋 | 國(guó)械備20140361號(hào) | ァルケァ株式會(huì)社 | 289-4 CHIGUSA-CHO, HANAMIGAWA-KU, CHIBA-SHI, CHIBA, JAPAN | 2025-05-28 | 變更 |
| 14 | 造口袋 | 國(guó)械備20190015號(hào) | アルケア株式會(huì)社 | 千葉県千葉市花見川區(qū)千種町36-2 | 2025-05-28 | 變更 |
| 15 | 造口皮膚保護(hù)劑 | 國(guó)械備20190017號(hào) | アルケア株式會(huì)社 | 千葉県千葉市花見川區(qū)千種町36-2 | 2025-05-28 | 變更 |
| 16 | 造口灌洗器 | 國(guó)械備20210041號(hào) | アルケア株式會(huì)社 | 千葉県千葉市花見川區(qū)千種町289-4 | 2025-05-28 | 變更 |
| 17 | 上頜竇咬骨鉗 | 國(guó)械備20150127號(hào) | Max Hauser Süeddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33,78532 Tuttlingen Germany | 2025-05-27 | 變更 |
| 18 | 吸引管 | 國(guó)械備20170478號(hào) | Max Hauser Süeddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33,78532 Tuttlingen Germany | 2025-05-27 | 變更 |
| 19 | 口腔科手術(shù)器械 | 國(guó)械備20220329號(hào) | LEGEND GROUP | Aeminabad Road,Village Adam Daraz,Sialkot-Pakistan | 2025-05-27 | 變更 |
| 20 | 口腔科手術(shù)器械 | 國(guó)械備20220516號(hào) | SMILE SURGICAL INSTRUMENTS | Mohalla Mollma Machi Khokhar,Head Marala Road,Sialkot-51310-Pakistan | 2025-05-27 | 變更 |
| 21 | 口腔治療器具 | 國(guó)械備20250147號(hào) | MEDIXDENT INTERNATIONAL | 47-A Ground Floor, Pak Block, Allama Iqbal Town Lahore - Pakistan | 2025-05-27 | 有效 |
| 22 | 基礎(chǔ)外科手術(shù)器械 | 國(guó)械備20250146號(hào) | HEXAMED(PRIVATE)LIMITED | Barlas Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan. | 2025-05-27 | 有效 |
| 23 | 口腔治療器具 | 國(guó)械備20250145號(hào) | Surtex Instruments Ltd. | Kingspark Business Centre, Unit 202, 152-178 Kingston Road, New Malden, KT3 3ST Great Britain. | 2025-05-27 | 有效 |
| 24 | 骨科手術(shù)器械 | 國(guó)械備20250144號(hào) | HEXAMED(PRIVATE)LIMITED | Barlas Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan. | 2025-05-27 | 有效 |
| 25 | 羊水細(xì)胞培養(yǎng)基 Chang Medium C | 國(guó)械備20160924號(hào) | Irvine Scientific, LLC | 2511 Daimler Street Santa Ana, CA 92705 USA | 2025-05-27 | 變更 |
| 26 | 羊水細(xì)胞培養(yǎng)基 | 國(guó)械備20151953號(hào) | Irvine Scientific, LLC | 2511 Daimler ST Santa Ana, CA USA 92705 | 2025-05-27 | 變更 |
| 27 | 羊水細(xì)胞培養(yǎng)基 Chang Medium C | 國(guó)械備20190795號(hào) | Irvine Scientific, LLC | 2511 Daimler Street, Santa Ana, CA 92705, USA | 2025-05-27 | 變更 |
| 28 | 外周血淋巴細(xì)胞培養(yǎng)基 | 國(guó)械備20160843號(hào) | Irvine Scientific, LLC | 2511 Daimler Street Santa Ana, CA 92705 USA | 2025-05-27 | 變更 |
| 29 | 羊水細(xì)胞培養(yǎng)基 Chang Medium® D | 國(guó)械備20160844號(hào) | Irvine Scientific, LLC | 2511 Daimler Street Santa Ana, CA 92705 USA | 2025-05-27 | 變更 |
| 30 | 骨髓細(xì)胞培養(yǎng)基 Chang Medium BMC | 國(guó)械備20190657號(hào) | Irvine Scientific, LLC | 2511 Daimler Street, Santa Ana, CA 92705, USA | 2025-05-27 | 變更 |
| 31 | 羊水細(xì)胞培養(yǎng)基 Chang Medium B | 國(guó)械備20190799號(hào) | Irvine Scientific, LLC | 2511 Daimler Street, Santa Ana, CA 92705, USA | 2025-05-27 | 變更 |
| 32 | 羊水細(xì)胞培養(yǎng)基 Chang Medium D | 國(guó)械備20190656號(hào) | Irvine Scientific, LLC | 2511 Daimler Street, Santa Ana, CA 92705, USA | 2025-05-27 | 變更 |
| 33 | 羊水細(xì)胞培養(yǎng)基 Chang Medium® In Situ | 國(guó)械備20160859號(hào) | Irvine Scientific, LLC | 2511 Daimler Street Santa Ana, CA 92705 USA | 2025-05-27 | 變更 |
| 34 | 骨髓細(xì)胞培養(yǎng)基 Chang Marrow | 國(guó)械備20190796號(hào) | Irvine Scientific, LLC | 2511 Daimler Street, Santa Ana, CA 92705, USA | 2025-05-27 | 變更 |
| 35 | 羊水細(xì)胞培養(yǎng)基 Chang Medium C | 國(guó)械備20190798號(hào) | Irvine Scientific, LLC | 2511 Daimler Street, Santa Ana, CA 92705, USA | 2025-05-27 | 變更 |
| 36 | 血細(xì)胞分析用溶血?jiǎng)?/span> | 國(guó)械備20150018號(hào) | HORIBA ABX SAS | Parc Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France | 2025-05-27 | 變更 |
| 37 | 樣本稀釋液 Alinity c ICT Sample Diluent | 國(guó)械備20181002號(hào) | Abbott GmbH | 8365 Valley Pike Middletown, VA 22645 USA | 2025-05-26 | 變更 |
| 38 | 呼吸訓(xùn)練器 | 國(guó)械備20150135號(hào) | Leventon S.A.U. | BP 245 Z.I. Hammam-Zriba, 1152 Zaghouan, Tunisie | 2025-05-26 | 無(wú)效 |
| 39 | 輪轉(zhuǎn)式切片機(jī) | 國(guó)械備20150178號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2025-05-23 | 變更 |
| 40 | 自動(dòng)組織脫水機(jī) | 國(guó)械備20140170號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2025-05-23 | 變更 |
| 41 | 冷凍切片機(jī) | 國(guó)械備20150255號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2025-05-23 | 變更 |
| 42 | 組織染色機(jī) | 國(guó)械備20140169號(hào) | MEDITE Medical GmbH | 國(guó)械備20140169 | 2025-05-23 | 變更 |
| 43 | 輪轉(zhuǎn)式切片機(jī) | 國(guó)械備20140038號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2025-05-23 | 變更 |
| 44 | 牙科種植器械工具 | 國(guó)械備20240264號(hào) | 8dent Inc. | 20-13, Seogimhaesandan-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea | 2025-05-23 | 變更 |
| 45 | 口腔燈 | 國(guó)械備20200564號(hào) | Takara Belmont Corporation | 2-6-59, Kitatsumori, Nishinari-ku, Osaka, 557-0061, Japan | 2025-05-22 | 變更 |
| 46 | 細(xì)胞周期蛋白D1抗體試劑(免疫組織化學(xué)) | 國(guó)械備20181772號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States | 2025-05-22 | 無(wú)效 |
| 47 | 牙科拋光條 | 國(guó)械備20161137號(hào) | 株式會(huì)社ジーシーデンタルプロダクツ | 愛知県春日井市鳥居松町2丁目285番地 | 2025-05-22 | 變更 |
| 48 | TdT 抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190518號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States | 2025-05-22 | 無(wú)效 |
| 49 | Myo D1抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190503號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States | 2025-05-22 | 無(wú)效 |
| 50 | GCDFP-15抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190475號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave. Carpinteria, CA 93013 United States | 2025-05-22 | 無(wú)效 |
| 51 | CD5抗體試劑(免疫組織化學(xué)) | 國(guó)械備20181775號(hào) | Agilent Technologies, Inc. | 1170 Mark Ave, Carpinteria, CA 93013 United States | 2025-05-22 | 無(wú)效 |
| 52 | 清洗液 | 國(guó)械備20190536號(hào) | Agilent Technologies, Inc. | Produktionsvej 42, DK-2600 Glostrup, Denmark;1170 Mark Ave, Carpinteria, CA 93013 United States | 2025-05-22 | 無(wú)效 |
| 53 | 造口皮膚保護(hù)劑 | 國(guó)械備20191410號(hào) | Coloplast A/S | ul.Szczakowska 35, 43-600 Jaworzno, Poland | 2025-05-22 | 變更 |
| 54 | 造口袋 | 國(guó)械備20200640號(hào) | Coloplast A/S | Coloplast Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary | 2025-05-22 | 變更 |
| 55 | 造口袋 | 國(guó)械備20190948號(hào) | Coloplast A/S | Búzavirág út 15, 2800 Tatabánya, Hungary | 2025-05-22 | 變更 |
| 56 | 骨鉸刀 | 國(guó)械備20170662號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 57 | 快裝手柄 | 國(guó)械備20170661號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 58 | 試模 | 國(guó)械備20170659號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 59 | 骨科用螺絲刀 | 國(guó)械備20170660號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 60 | 打孔器 | 國(guó)械備20170655號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 61 | 導(dǎo)鉆 | 國(guó)械備20170658號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 62 | 拔出器 | 國(guó)械備20170657號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 63 | 骨測(cè)量器 | 國(guó)械備20170653號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 64 | 骨銼 | 國(guó)械備20170656號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 65 | 骨科定位片 | 國(guó)械備20170654號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 66 | 打入器 | 國(guó)械備20170652號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 67 | 固定針 | 國(guó)械備20170651號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 68 | 骨鉆 | 國(guó)械備20171231號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 69 | 試模 | 國(guó)械備20171230號(hào) | Ortho Development Corporation | 12187 S. Business Park Drive, Draper, Utah, 84020-8663, USA | 2025-05-22 | 變更 |
| 70 | 耳鏡 | 國(guó)械備20190791號(hào) | Rudolf Riester GmbH | Bruckstraβe 31, 72417 Jungingen, Germany | 2025-05-22 | 變更 |
| 71 | 耳鏡 | 國(guó)械備20210416號(hào) | Rudolf Riester GmbH | Bruckstraβe 31, 72417 Jungingen, Germany | 2025-05-22 | 變更 |
| 72 | 雙翼陰道擴(kuò)張器 | 國(guó)械備20160356號(hào) | Rudolf Riester GmbH | Small Industrial Estate, Sialkot-Pakistan | 2025-05-22 | 變更 |
| 73 | 病理石蠟包埋機(jī) | 國(guó)械備20140213號(hào) | MEDITE Medical GmbH | Wollenweberstrasse 12, 31303 Burgdorf | 2025-05-22 | 變更 |
| 74 | 染色機(jī) | 國(guó)械備20151321號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19 69226 Nussloch Germany | 2025-05-22 | 無(wú)效 |
| 75 | 全自動(dòng)染色封片一體機(jī) | 國(guó)械備20230396號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19, 69226 Nussloch, Germany | 2025-05-22 | 變更 |
| 76 | 染色機(jī) | 國(guó)械備20151853號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19 69226 Nussloch Germany | 2025-05-22 | 變更 |
| 77 | 封片機(jī) | 國(guó)械備20220343號(hào) | Leica Biosystems Nussloch GmbH | Heidelberger Strasse 17-19 69226 Nussloch Germany | 2025-05-22 | 變更 |
| 78 | 打磨拋光器具 | 國(guó)械備20250143號(hào) | Hopf, Ringleb & Co. GmbH & Cie. | Gardeschützenweg 82 12203 Berlin Germany | 2025-05-22 | 有效 |
| 79 | 醫(yī)用激光膠片 | 國(guó)械備20171024號(hào) | コニカミノルタ株式會(huì)社 | 8124 Pacific Avenue White City,Oregen USA 97503;日本埼玉県久喜市菖蒲町三箇6201-6 | 2025-05-21 | 變更 |
| 80 | 聽覺檢查音叉 | 國(guó)械備20170546號(hào) | Rudolf Riester GmbH | Bruckstraße 31, 72417 Jungingen, Germany | 2025-05-21 | 變更 |
| 81 | 醫(yī)用檢查燈 | 國(guó)械備20190355號(hào) | Rudolf Riester GmbH | Bruckstraβe 31, 72417 Jungingen, Germany | 2025-05-21 | 變更 |
| 82 | 二用聽診器 | 國(guó)械備20150317號(hào) | Rudolf Riester GmbH | Bruckstraβe 31 72417 Jungingen, Germany | 2025-05-21 | 變更 |
| 83 | 手術(shù)放大鏡 | 國(guó)械備20151134號(hào) | Rudolf Riester GmbH | Clewer Hill Road, Windsor, Berkshire SL4 4AA, United Kingdom | 2025-05-21 | 變更 |
| 84 | 基礎(chǔ)外科手術(shù)器械 | 國(guó)械備20250142號(hào) | Central Surgical Co. (Pvt) Ltd | Hari Pur Choek, 1.5 Km Durganwafi Vil/BhagowalRoad,Sialkot 51310-Pakistan | 2025-05-19 | 有效 |
| 85 | CD10抗體試劑(免疫組織化學(xué)) | 國(guó)械備20180355號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 86 | Neurofilament抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190524號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 87 | 核酸提取或純化試劑 | 國(guó)械備20180699號(hào) | Vela Operations Singapore Pte Ltd. | NEUMANN-NEANDER-STR. 6-8, 52355 DUREN DEUTSCHLAND | 2025-05-16 | 無(wú)效 |
| 88 | 核酸提取或純化試劑 | 國(guó)械備20170592號(hào) | Vela Operations Singapore Pte Ltd. | 50 Science Park Road, The Kendall #05-07, Singapore 117406 | 2025-05-16 | 無(wú)效 |
| 89 | 核酸提取或純化試劑 | 國(guó)械備20200112號(hào) | Vela Operations Singapore Pte Ltd. | 1. Neumann-Neander-Str. 6-8 52355 Düren Deutschland 2. #05- 07, The Kendall, 50 Science Park Road, Science Park II, 117406 Singapore | 2025-05-16 | 無(wú)效 |
| 90 | 剔挖器 | 國(guó)械備20250141號(hào) | 株式會(huì)社背戸製作所 | 茨城県つくば市小田4596の1 | 2025-05-16 | 有效 |
| 91 | Vimentin抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190917號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 92 | 膠質(zhì)纖維酸性蛋白(Glial Fibrillary Acidic Protein,GFAP)抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190484號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 93 | CD2抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190512號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 94 | CD10抗體試劑(免疫組織化學(xué)) | 國(guó)械備20180350號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 95 | CA125抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190511號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 96 | 潛伏膜蛋白(EBV,LMP-1)抗體試劑(免疫組織化學(xué)) | 國(guó)械備20220176號(hào) | Agilent Technologies Singapore (International) Pte. Ltd. | Produktionsvej 42 Glostrup DK-2600 Denmark | 2025-05-16 | 無(wú)效 |
| 97 | CD23抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190522號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 98 | 免疫組化抗原修復(fù)緩沖液 | 國(guó)械備20181782號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 99 | Alpha-1-Fetoprotein抗體試劑(免疫組織化學(xué)) | 國(guó)械備20181756號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 100 | AAT抗體試劑(免疫組織化學(xué)) | 國(guó)械備20181761號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-16 | 無(wú)效 |
| 101 | IgG抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190909號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-15 | 無(wú)效 |
| 102 | IgM 抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190510號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-15 | 無(wú)效 |
| 103 | CEA抗體試劑(免疫組織化學(xué)) | 國(guó)械備20180359號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-15 | 無(wú)效 |
| 104 | CD43抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190509號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-15 | 無(wú)效 |
| 105 | 細(xì)胞角蛋白18抗體試劑(免疫組織化學(xué)) | 國(guó)械備20190505號(hào) | Agilent Technologies Singapore (International) Pte Ltd. | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2025-05-15 | 無(wú)效 |
| 106 | 外科牽開器 | 國(guó)械備20161755號(hào) | Max Hauser Süeddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33,78532 Tuttlingen Germany | 2025-05-15 | 變更 |
| 107 | 牙科拋光磨頭 | 國(guó)械備20190463號(hào) | SS White Burs LLC | Neureutstraβe 6 75210 Keltern Germany | 2025-05-14 | 變更 |
| 108 | 根管銼 | 國(guó)械備20170953號(hào) | SS White Burs LLC | 1145 Towbin Avenue, Lakewood, New Jersey, 08701 USA | 2025-05-14 | 變更 |
| 109 | 口腔科雙組份材料混配槍 | 國(guó)械備20170502號(hào) | Kerr Corporation also trading as Pentron Clinical | Ruetistrasse 7 Haag, Sankt Gallen Switzerland 9469 | 2025-05-14 | 變更 |
| 110 | 顯微眼用剪 | 國(guó)械備20151126號(hào) | Max Hauser Süeddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33,78532 Tuttlingen Germany | 2025-05-14 | 變更 |
| 111 | 咬骨鉗 | 國(guó)械備20140275號(hào) | Max Hauser Süeddeutsche Chirurgiemechanik GmbH | Fohrenstraβe 33,78532 Tuttlingen Germany | 2025-05-14 | 變更 |
| 112 | 持針器 | 國(guó)械備20170102號(hào) | Max Hauser Süeddeutsche Chirurgiemechanik GmbH | Föhrenstraße 33,78532 Tuttlingen Germany | 2025-05-14 | 變更 |
| 113 | 眼科手術(shù)非接觸觀察裝置 | 國(guó)械備20250140號(hào) | Volk Optical Inc. | 7893 Enterprise Drive Mentor, Ohio 44060 USA | 2025-05-14 | 有效 |
| 114 | 放射治療患者用固定裝置 | 國(guó)械備20230364號(hào) | MEDTEC LLC | 1401 8th St.SE,Orange City,IA,51041,United States | 2025-05-14 | 變更 |
| 115 | 樣本稀釋液 | 國(guó)械備20250139號(hào) | Siemens Healthcare Diagnostics Products Limited | 333 Coney Street, East Walpole MA 02032, USA | 2025-05-13 | 有效 |
| 116 | 全自動(dòng)樣品處理系統(tǒng) | 國(guó)械備20220379號(hào) | Inpeco S.A. | Via Givoletto 15 I-10040, Val della Torre (TO), Italy | 2025-05-13 | 無(wú)效 |
| 117 | 全自動(dòng)樣本處理系統(tǒng) | 國(guó)械備20151954號(hào) | Beckman Coulter, Inc. | Sauerbruchstr. 50, 81377, Muenchen, Germany | 2025-05-12 | 變更 |
| 118 | 自動(dòng)樣本處理系統(tǒng) | 國(guó)械備20150277號(hào) | Beckman Coulter, Inc. | 8-14-30 Nagaminehigashi, Higashi-ku, Kumamoto-shi, Kumamoto-ken Japan | 2025-05-12 | 變更 |
| 119 | 種植體螺絲起 | 國(guó)械備20190674號(hào) | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412?(????, ??????????) | 2025-05-12 | 變更 |
| 120 | 咬骨鉗 | 國(guó)械備20160327號(hào) | Hu-Friedy Mfg. Co., LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-05-12 | 變更 |
| 121 | 止血鉗 | 國(guó)械備20160189號(hào) | Hu-Friedy Mfg.Co.,LLC | 1666 E. Touhy Ave, Des Plaines, IL 60018-3607, United States | 2025-05-12 | 變更 |
| 122 | 牙科輸送頭 | 國(guó)械備20170924號(hào) | Ivoclar Vivadent AG | Bendererstrasse 2, 9494 Schaan, Liechtenstein | 2025-05-12 | 變更 |
| 123 | 種植輔助材料 | 國(guó)械備20240092號(hào) | Izenimplant Co., Ltd. | 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do | 2025-05-08 | 變更 |
| 124 | 手動(dòng)測(cè)量用器械 | 國(guó)械備20240091號(hào) | Izenimplant Co., Ltd. | 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do | 2025-05-08 | 變更 |
| 125 | 種植用牙鉆限深導(dǎo)向器 | 國(guó)械備20240093號(hào) | Izenimplant Co., Ltd. | 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do | 2025-05-08 | 變更 |
| 126 | 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 | 2025-05-08 | 變更 |
| 127 | 種植體安裝輔助器械 | 國(guó)械備20240109號(hào) | Izenimplant Co., Ltd. | 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do | 2025-05-08 | 變更 |
| 128 | 彈力繃帶 | 國(guó)械備20171053號(hào) | ? ?????????????? | ??? ??? ??? ??? 1424?? 17-40 | 2025-05-08 | 變更 |
| 129 | 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 | 2025-05-07 | 變更 |
| 130 | 造口袋 | 國(guó)械備20240105號(hào) | ConvaTec Limited | Priemyselny Park 3 07101 Michalovce Slovakia | 2025-05-07 | 變更 |
| 131 | 足部固定器 | 國(guó)械備20250138號(hào) | medi GmbH & Co. KG | Elbringhausen 2 + 4, 42929 Wermelskirchen, Germany | 2025-05-07 | 有效 |
| 132 | 心電導(dǎo)聯(lián)線 | 國(guó)械備20250137號(hào) | GE Medical Systems Information Technologies, Inc. | 2F,5F No. 21 Jiankang Rd. Zhonghe Dist., New Taipei City 235, Taiwan | 2025-05-07 | 有效 |
| 133 | 種植體周圍炎處理套裝 | 國(guó)械備20250136號(hào) | Osstem Implant Co., Ltd. | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea | 2025-05-07 | 有效 |
| 134 | 種植體清潔用螺絲 | 國(guó)械備20250135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 | 2025-05-07 | 有效 |
| 135 | 牙探針 | 國(guó)械備20250134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 | 2025-05-07 | 有效 |
| 136 | 種植體清潔刷 | 國(guó)械備20250133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 | 2025-05-07 | 有效 |
| 137 | 牙刮匙 | 國(guó)械備20250132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 | 2025-05-07 | 有效 |
| 138 | 超聲潔牙機(jī)工作尖 | 國(guó)械備20250131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 | 2025-05-07 | 有效 |
| 139 | 口腔科技工室用間隙帽 | 國(guó)械備20250070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 | 2025-05-07 | 變更 |
| 140 | 冷凍切片機(jī) | 國(guó)械備20140034號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 141 | 自動(dòng)切片機(jī) | 國(guó)械備20140035號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 142 | 液基薄層細(xì)胞制片機(jī) | 國(guó)械備20150480號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 143 | 自動(dòng)組織脫水機(jī) | 國(guó)械備20150481號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 144 | 細(xì)胞保存液 | 國(guó)械備20151079號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 145 | 組織脫水機(jī) | 國(guó)械備20220090號(hào) | Amos Scientific Pty. Ltd | 7 Gabrielle Court, Bayswater North VIC 3153,Australia | 2025-05-06 | 無(wú)效 |
| 146 | 全自動(dòng)組織染色機(jī) | 國(guó)械備20220089號(hào) | Amos Scientific Pty. Ltd | 7 Gabrielle Court, Bayswater North VIC 3153,Australia | 2025-05-06 | 無(wú)效 |
| 147 | 冷凍切片機(jī) | 國(guó)械備20180806號(hào) | Amos Scientific Pty .Ltd | 7 Gabrielle Court, Bayswater North VIC 3153,Australia | 2025-05-06 | 無(wú)效 |
| 148 | 冷凍切片機(jī) | 國(guó)械備20180801號(hào) | Amos Scientific Pty .Ltd | 7 Gabrielle Court, Bayswater North VIC 3153,Australia | 2025-05-06 | 無(wú)效 |
| 149 | 染色機(jī) | 國(guó)械備20180808號(hào) | Amos Scientific Pty .Ltd | 7 Gabrielle Court, Bayswater North VIC 3153,Australia | 2025-05-06 | 無(wú)效 |
| 150 | 耳鼻喉科手術(shù)器械 | 國(guó)械備20161455號(hào) | Spiggle & Theis Medizintechnik GmbH | Burghof 14 51491 Overath Germany | 2025-05-06 | 變更 |
| 151 | 自動(dòng)切片機(jī) | 國(guó)械備20140033號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 152 | 冷凍切片機(jī) | 國(guó)械備20140032號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 153 | 手搖切片機(jī) | 國(guó)械備20140031號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 154 | 染色機(jī) | 國(guó)械備20140030號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 155 | 自動(dòng)切片機(jī) | 國(guó)械備20140029號(hào) | AMOS SCIENTIFIC PTY.LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 156 | 包埋機(jī) | 國(guó)械備20140010號(hào) | AMOS SCIENTIFIC PTY. LTD | 7 Gabrielle Court, Bayswater North VIC 3153,Melbourne,Australia | 2025-05-06 | 無(wú)效 |
| 157 | 組織鉗 | 國(guó)械備20151364號(hào) | Landanger | ZI La Vendue,FR-52906 Chaumont Cedex 9 | 2025-05-06 | 變更 |
| 158 | 液基薄層細(xì)胞制片染色系統(tǒng) | 國(guó)械備20170423號(hào) | Amos Scientific Pty .Ltd | 7 Gabrielle Court, Bayswater North VIC 3153,Australia | 2025-05-06 | 無(wú)效 |

來(lái)源:國(guó)家藥監(jiān)局