NMPA - 2020-11-02
| 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 | 牙科電動(dòng)抽吸系統(tǒng) | 國械備20170509號(hào) | AIR TECHNIQUES INC | 1295 Walt Whitman Road, Melville, NY 11747 | 2020-03-31 | 變更 |
| 2 | 牙科電動(dòng)空壓機(jī) | 國械備20171112號(hào) | AIR TECHNIQUES INC | 1295 Walt Whitman Road, Melville, NY 11747 | 2020-03-31 | 變更 |
| 3 | 緩沖液 | 國械備20200134號(hào) | FUJIFILM Irvine Scientific, Inc. | 2511 Daimler Street, Santa Ana, CA 92705 USA | 2020-03-31 | 有效 |
| 4 | 醫(yī)用干式膠片 | 國械備20200133號(hào) | Agfa NV | Septestraat 27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina 29445, USA | 2020-03-31 | 有效 |
| 5 | 醫(yī)用檢查手套 | 國械備20200132號(hào) | Mexpo International Inc. | Lot 4969,Jalan Teratai, Batu 6, Off Jalan Meru,41050 Klang, Selangor Darul Ehsan, Malaysia | 2020-03-31 | 有效 |
| 6 | 神經(jīng)和肌肉刺激器用體表電極 | 國械備20200131號(hào) | Bioness Inc. | 25103 Rye Canyon Loop Valencia California 91355 USA | 2020-03-30 | 有效 |
| 7 | 軟骨壓碎器 | 國械備20200130號(hào) | devemed GmbH | take-off GewerbePark 30 78579 Neuhausen ob ECK | 2020-03-30 | 有效 |
| 8 | 緩沖液 | 國械備20191203號(hào) | Roche Diagnostics GmbH | Sandhofer Strasse 116,68305 Mannheim,Germany | 2020-03-30 | 變更 |
| 9 | CD27檢測(cè)試劑(流式細(xì)胞儀法) | 國械備20200129號(hào) | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2020-03-27 | 有效 |
| 10 | CD41檢測(cè)試劑（流式細(xì)胞儀法） | 國械備20200128號(hào) | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2020-03-27 | 有效 |
| 11 | CD61檢測(cè)試劑（流式細(xì)胞儀法） | 國械備20200127號(hào) | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2020-03-27 | 有效 |
| 12 | IgG抗體檢測(cè)補(bǔ)充試劑盒（印跡法） | 國械備20200126號(hào) | EUROIMMUN Medizinische Labordiagnostika AG | Werkstraβe 1, 23942 Dassow, Germany | 2020-03-27 | 有效 |
| 13 | 達(dá)雷妥尤單抗干擾移除劑 | 國械備20200125號(hào) | SEBIA | Parc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX FRANCE | 2020-03-27 | 有效 |
| 14 | 牙科種植器械限深套 | 國械備20200124號(hào) | Anthogyr SAS | 2237 avenue André Lasquin, 74700 SALLANCHES FRANCE | 2020-03-27 | 有效 |
| 15 | 一件式造口袋 | 國械備20200123號(hào) | ConvaTec Limited | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2020-03-27 | 有效 |
| 16 | 骨科手術(shù)器械 | 國械備20200122號(hào) | Cardic Instruments | P.O. Box: 147, Nishat Park, Opposite: Sialkot Chamber of Commerce & Industry, Sialkot-51310-Pakistan | 2020-03-27 | 有效 |
| 17 | 醫(yī)用橡膠檢查手套 | 國械備20200121號(hào) | JR Engineering and Medical Technologies (M) SDN BHD | Lot 8 &10,Jalan Zurah 3 & Lot 1 & 3,Jalan Zurah 3A/1,Pusat Perindustrian 2,44200 RASA,Hulu Selangor,Selangor Darul Ehsan,Malaysia | 2020-03-27 | 有效 |
| 18 | 叩診錘 | 國械備20200120號(hào) | 精國醫(yī)療器材有限公司 | 新北市蘆洲區(qū)國道路二段68號(hào)2樓 | 2020-03-27 | 有效 |
| 19 | 耳鏡 | 國械備20200119號(hào) | 精國醫(yī)療器材有限公司 | 新北市蘆洲區(qū)國道路二段68號(hào)2樓 | 2020-03-27 | 有效 |
| 20 | 種植用手術(shù)導(dǎo)板 | 國械備20151335號(hào) | Osstem Implant Co.,Ltd. | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea | 2020-03-27 | 變更 |
| 21 | 牙用尺 | 國械備20150781號(hào) | Osstem Implant Co.,Ltd. | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea | 2020-03-27 | 變更 |
| 22 | 螺絲起 | 國械備20150871號(hào) | ???????(?) | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea | 2020-03-27 | 變更 |
| 23 | 牙科種植定位器 | 國械備20150799號(hào) | Osstem Implant Co.,Ltd. | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea | 2020-03-27 | 變更 |
| 24 | 置骨器 | 國械備20151366號(hào) | Osstem Implant Co.,Ltd. | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea | 2020-03-27 | 變更 |
| 25 | 膝關(guān)節(jié)手術(shù)工具 | 國械備20200118號(hào) | DePuy (Ireland) | 詳見附件“生產(chǎn)地址" | 2020-03-26 | 有效 |
| 26 | 檢查手套 | 國械備20170681號(hào) | Sri Trang Gloves (Thailand) Co., Ltd. | 109/2 Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand | 2020-03-26 | 變更 |
| 27 | 打拔器 | 國械備20150557號(hào) | Smith & Nephew Orthopaedics AG | Oberneuhofstrasse 10d 6340 Baar, Switzerland | 2020-03-26 | 無效 |
| 28 | 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 | 2020-03-25 | 有效 |
| 29 | 種植體安裝輔助器械 | 國械備20190350號(hào) | ALTATEC GmbH | Maybachstr. 5, 71299 Wimsheim, GERMANY | 2020-03-25 | 變更 |
| 30 | 負(fù)氣壓式骨折固定保護(hù)氣墊 | 國械備20170145號(hào) | OPED GmbH | Medizinpark 1 83626 Valley/Oberlaindern GERMANY | 2020-03-25 | 變更 |
| 31 | 自動(dòng)組織脫水機(jī) | 國械備20151900號(hào) | Leica Biosystems Melbourne Pty Ltd | 495 Blackburn Road Mt Waverley Victoria 3149 Australia | 2020-03-24 | 無效 |
| 32 | 髖關(guān)節(jié)手術(shù)工具 | 國械備20181628號(hào) | Zimmer, Inc. | 1800 W. Center Street Warsaw Indiana 46580 USA | 2020-03-23 | 變更 |
| 33 | 造口皮膚保護(hù)劑 | 國械備20190695號(hào) | ConvaTec Limited | Hickmans Road, Birkenhead, Wirral CH41 1JH United Kingdom | 2020-03-23 | 變更 |
| 34 | 造口護(hù)理用品 | 國械備20200116號(hào) | Welland Medical Limited | Hydehurst Lane, Crawley, West Sussex, RH10 9AS, United Kingdom | 2020-03-20 | 有效 |
| 35 | 創(chuàng)口貼 | 國械備20200115號(hào) | 泰宗生物科技股份有限公司 | 南部科學(xué)工業(yè)園區(qū)高雄市路竹區(qū)路科二路65號(hào)1樓 | 2020-03-20 | 有效 |
| 36 | 導(dǎo)引針 | 國械備20200114號(hào) | Search Medical Co., Ltd. | 16, Cheomdan venture so-ro 37 beon-gil, Buk-gu, Gwangju, Republic of Korea | 2020-03-20 | 有效 |
| 37 | 造口護(hù)理用品 | 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 | 2020-03-19 | 變更 |
| 38 | 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. | 2020-03-18 | 變更 |
| 39 | 檢查手套 | 國械備20171093號(hào) | Riverstone Resources Sdn. Bhd. | Lot 55＆56, No. 13, Jalan Jasmine 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor, MALAYSIA | 2020-03-17 | 變更 |
| 40 | 干式激光成像儀 | 國械備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 | 2020-03-16 | 變更 |
| 41 | 干式激光成像儀 | 國械備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 | 2020-03-16 | 變更 |
| 42 | 干式激光成像儀 | 國械備20160861號(hào) | コニカミノルタ株式會(huì)社 | 2-2-1， Hirosedai，Sayama-shi，Saitama | 2020-03-16 | 變更 |
| 43 | 干式激光成像儀 | 國械備20151259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 | 2020-03-16 | 變更 |
| 44 | 脊柱用手術(shù)工具 | 國械備20200113號(hào) | Medtronic Sofamor Danek USA, Inc. | 4340 Swinnea Road, Memphis, TN 38118, USA | 2020-03-12 | 有效 |
| 45 | 螺絲起 | 國械備20171123號(hào) | HumanTech Dental GmbH | Gewerbestrasse 5, 71144 Steinenbronn, Germany | 2020-03-12 | 變更 |
| 46 | 轉(zhuǎn)移帽 | 國械備20170917號(hào) | HumanTech Germany GmbH | Gewerbestrasse 5, 71144 Steinenbronn, Germany | 2020-03-12 | 變更 |
| 47 | 可調(diào)式固定支具 | 國械備20151554號(hào) | Orthobroker bvba | Ter Stratenweg 11 - 2520 Ranst - Belgium | 2020-03-12 | 變更 |
| 48 | 足托固定器 | 國械備20151512號(hào) | Orthobroker bvba | Ter Stratenweg 11 - 2520 Ranst - Belgium | 2020-03-12 | 變更 |
| 49 | 頸椎固定器 | 國械備20151511號(hào) | Orthobroker bvba | Ter Stratenweg 11 - 2520 Ranst - Belgium | 2020-03-12 | 變更 |
| 50 | 腰椎固定帶 | 國械備20151510號(hào) | Orthobroker bvba | Ter Stratenweg 11 - 2520 Ranst - Belgium | 2020-03-12 | 變更 |
| 51 | 醫(yī)用外固定支具 | 國械備20151513號(hào) | Orthobroker bvba | Ter Stratenweg 11 - 2520 Ranst - Belgium | 2020-03-12 | 變更 |
| 52 | 核酸提取或純化試劑 | 國械備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 | 2020-03-11 | 有效 |
| 53 | 骨科手術(shù)器械 | 國械備20200111號(hào) | ORTHO-MEDICAL GmbH | Hauptstraße 5 78589 Dürbheim Germany | 2020-03-11 | 有效 |
| 54 | 造口底盤 | 國械備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. | 2020-03-11 | 有效 |
| 55 | 牙科電動(dòng)抽吸機(jī) | 國械備20200109號(hào) | 株式會(huì)社東京技研 | 神奈川県橫浜市都筑區(qū)東山田4-42-37 | 2020-03-11 | 有效 |
| 56 | 口腔科手術(shù)器械 | 國械備20200108號(hào) | devemed GmbH | take-off GewerbePark 30 78579 Neuhausen ob ECK | 2020-03-10 | 有效 |
| 57 | 樣本稀釋液 | 國械備20150466號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 58 | 緩沖液 | 國械備20150470號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 59 | 緩沖液 | 國械備20150464號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 60 | 核酸提取試劑 | 國械備20200107號(hào) | 倉敷紡績(jī)株式會(huì)社 | 日本國大阪府寢屋川市下木田町14-5 | 2020-03-10 | 有效 |
| 61 | 樣本稀釋液 | 國械備20200106號(hào) | Ortho-Clinical Diagnostics, Inc. | 1000 Lee Road Rochester, New York 14606, USA | 2020-03-10 | 有效 |
| 62 | 樣本保存液 | 國械備20200105號(hào) | Copan Italia S. p. A. | Via F. Perotti 18, 25125 Brescia, Italy; Via F. Perotti 10, 25125 Brescia, Italy | 2020-03-10 | 有效 |
| 63 | CD2抗體試劑（免疫組織化學(xué)） | 國械備20190512號(hào) | Dako Denmark A/S | Produktionsvej 42, DK-2600 Glostrup, Denmark | 2020-03-10 | 變更 |
| 64 | 清洗液 | 國械備20161828號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 65 | 樣本稀釋液 | 國械備20170463號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 66 | 清洗液 | 國械備20161827號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 67 | 清洗液 | 國械備20161812號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 68 | 緩沖液 | 國械備20170379號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 69 | 樣本稀釋液 | 國械備20161811號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 70 | 緩沖液 | 國械備20170378號(hào) | Trinity Biotech(Primus Corporation dba Trinity Biotech) | 4231 E.75th Terrace Kansas City, Missouri, 64132, USA | 2020-03-10 | 變更 |
| 71 | 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 | 2020-03-09 | 變更 |
| 72 | 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. | 2020-03-09 | 變更 |
| 73 | 造口袋 | 國械備20190626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. | 2020-03-09 | 變更 |
| 74 | 造口袋 | 國械備20190930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. | 2020-03-09 | 變更 |
| 75 | 造口袋 | 國械備20191032號(hào) | ConvaTec Limited | Wendenschloßstraße 142,12557 Berlin Deutschland | 2020-03-09 | 變更 |
| 76 | 造口減壓環(huán) | 國械備20151614號(hào) | ConvaTec Limited | 1405 Dogwood Way, Mebrane, NC 27302, USA | 2020-03-09 | 變更 |
| 77 | 造口凸面嵌圈 | 國械備20150925號(hào) | ConvaTec Limited | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic. | 2020-03-09 | 變更 |
| 78 | 拉鉤 | 國械備20200104號(hào) | SOS Surgical Co. | Mughal Pura, Gohad Pur, Sialkot, Pakistan | 2020-03-06 | 有效 |
| 79 | 手術(shù)剪 | 國械備20200103號(hào) | SOS Surgical Co. | Mughal Pura, Gohad Pur, Sialkot, Pakistan | 2020-03-06 | 有效 |
| 80 | 鼻骨鑿 | 國械備20200102號(hào) | SOS Surgical Co. | Mughal Pura, Gohad Pur, Sialkot, Pakistan | 2020-03-06 | 有效 |
| 81 | 口腔科手術(shù)器械 | 國械備20200101號(hào) | Helmut Zepf Medizintechnik GmbH | Hauptstraβe 60, 78606 Seitingen-Oberflacht, Germany | 2020-03-06 | 有效 |
| 82 | 髖關(guān)節(jié)手術(shù)器械 | 國械備20161805號(hào) | Smith & Nephew Orthopaedics AG | Schachenalle 29,5001 Aarau, Switzerland; Dammweg 39,5001 Aarau, Switzerland; Oberneuhofstrasse 10a, 6340 Baar, Switzerland; Boulevard Héctor Terán Terán #20120, Ciudad Industrial, Tijuana, B.C.,22444, Mexico |
2020-03-06 | 變更 |
| 83 | 膝關(guān)節(jié)固定器 | 國械備20170278號(hào) | Össur hf. | Grjotháls 1-5 Reykjavik 110 Iceland | 2020-03-06 | 變更 |
| 84 | 鈣石灰 | 國械備20161369號(hào) | Molecular Products Ltd | Parkway, Harlow Business Park, Harlow, CM19 5FR, United Kingdom | 2020-03-06 | 變更 |
| 85 | 顯微剪 | 國械備20190222號(hào) | S&T AG | Tobelraastr.2, 8212 Neuhausen am Rheinfall, SWITZERLAND | 2020-03-04 | 變更 |
| 86 | 醫(yī)用檢查手套 | 國械備20200100號(hào) | Ever Global (Vietnam) Ent.Corp - Giang Dien Factory | No 9 Street, Giang Dien Industrial Park, Trang Bom District, Dong Nai Province, VIETNAM | 2020-03-04 | 有效 |
| 87 | 修復(fù)重建顯微工具套裝 | 國械備20190554號(hào) | S&T AG | Tobelraastr.2, 8212 Neuhausen am Rheinfall, SWITZERLAND | 2020-03-04 | 變更 |
| 88 | 兩件式造口袋 | 國械備20140062號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic. | 2020-03-04 | 變更 |
| 89 | 防漏膏 | 國械備20190264號(hào) | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2020-03-04 | 變更 |
| 90 | 組織鉗 | 國械備20200099號(hào) | BLACKSMITH SURGICAL | Near Noul Chowk，Wazirabad Road，Sialkot-Pakistan | 2020-03-03 | 有效 |
| 91 | 拔牙鉗 | 國械備20200098號(hào) | BLACKSMITH SURGICAL | Near Noul Chowk，Wazirabad Road，Sialkot-Pakistan | 2020-03-03 | 有效 |
| 92 | 手術(shù)剪 | 國械備20200097號(hào) | BLACKSMITH SURGICAL | Near Noul Chowk，Wazirabad Road，Sialkot-Pakistan | 2020-03-03 | 有效 |
| 93 | 陰道牽開器 | 國械備20200096號(hào) | BLACKSMITH SURGICAL | Near Noul Chowk，Wazirabad Road，Sialkot-Pakistan | 2020-03-03 | 有效 |
| 94 | 組織鑷 | 國械備20200095號(hào) | BLACKSMITH SURGICAL | Near Noul Chowk，Wazirabad Road，Sialkot-Pakistan | 2020-03-03 | 有效 |
| 95 | 刮匙 | 國械備20200094號(hào) | BLACKSMITH SURGICAL | Near Noul Chowk，Wazirabad Road，Sialkot-Pakistan | 2020-03-03 | 有效 |
| 96 | 核酸提取試劑 | 國械備20200093號(hào) | 倉敷紡績(jī)株式會(huì)社 | 日本國大阪府寢屋川市下木田町14-5 | 2020-03-03 | 有效 |
| 97 | 骨科手術(shù)器械 | 國械備20200091號(hào) | Eltek Instruments Pvt. Ltd. | 10km Wazirabad Road Raypur Sialkot,Pakistan. | 2020-03-02 | 有效 |
| 98 | 創(chuàng)口貼 | 國械備20180851號(hào) | Reskin Medical nv | Ravenshout Z 5.2.50 3980 Tessenderio, Belgium | 2020-03-02 | 變更 |
| 99 | 呼吸訓(xùn)練器 | 國械備20200090號(hào) | 貝斯美德股份有限公司 | 新北市五股區(qū)五工二路116巷5號(hào) | 2020-03-02 | 有效 |
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