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2020年03月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2020-04-09 22:08瀏覽次數(shù):3449次
2020年4月7日，國家藥監(jiān)總局發(fā)布《2020年03月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，99個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案被批準(zhǔn)。

引言：2020年4月7日，國家藥監(jiān)總局發(fā)布《2020年03月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，99個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案被批準(zhǔn)。

醫(yī)療器械產(chǎn)品備案.jpg

2020年03月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

序號產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1牙科電動抽吸系統(tǒng)國械備20170509號AIR TECHNIQUES INC 1295 Walt Whitman Road, Melville, NY 117472020-03-31變更
2牙科電動空壓機(jī)國械備20171112號AIR TECHNIQUES INC1295 Walt Whitman Road, Melville, NY 117472020-03-31變更
3緩沖液國械備20200134號FUJIFILM Irvine Scientific, Inc. 2511 Daimler Street, Santa Ana, CA 92705 USA2020-03-31有效
4醫(yī)用干式膠片國械備20200133號Agfa NVSeptestraat 27, 2640 Mortsel, Belgium; 1658 Bushy Park Road, Goose Creek, South Carolina 29445, USA2020-03-31有效
5醫(yī)用檢查手套國械備20200132號Mexpo International Inc.Lot 4969,Jalan Teratai, Batu 6, Off Jalan Meru,41050 Klang, Selangor Darul Ehsan, Malaysia2020-03-31有效
6神經(jīng)和肌肉刺激器用體表電極國械備20200131號Bioness Inc.25103 Rye Canyon Loop Valencia California 91355 USA2020-03-30有效
7軟骨壓碎器國械備20200130號devemed GmbHtake-off GewerbePark 30 78579 Neuhausen ob ECK2020-03-30有效
8緩沖液國械備20191203號Roche Diagnostics GmbHSandhofer Strasse 116,68305 Mannheim,Germany2020-03-30變更
9CD27檢測試劑(流式細(xì)胞儀法)國械備20200129號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
10CD41檢測試劑（流式細(xì)胞儀法）國械備20200128號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
11CD61檢測試劑（流式細(xì)胞儀法）國械備20200127號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
12IgG抗體檢測補(bǔ)充試劑盒（印跡法）國械備20200126號EUROIMMUN Medizinische Labordiagnostika AGWerkstraβe 1, 23942 Dassow, Germany2020-03-27有效
13達(dá)雷妥尤單抗干擾移除劑國械備20200125號SEBIAParc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX FRANCE2020-03-27有效
14牙科種植器械限深套國械備20200124號Anthogyr SAS2237 avenue André Lasquin, 74700 SALLANCHES FRANCE2020-03-27有效
15一件式造口袋國械備20200123號ConvaTec LimitedCarretera 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Cardic InstrumentsP.O. Box: 147, Nishat Park, Opposite: Sialkot Chamber of Commerce & Industry, Sialkot-51310-Pakistan2020-03-27有效
17醫(yī)用橡膠檢查手套國械備20200121號JR Engineering and Medical Technologies (M) SDN BHDLot 8 &10,Jalan Zurah 3 & Lot 1 & 3,Jalan Zurah 3A/1,Pusat Perindustrian 2,44200 RASA,Hulu Selangor,Selangor Darul Ehsan,Malaysia2020-03-27有效
18叩診錘國械備20200120號精國醫(yī)療器材有限公司新北市蘆洲區(qū)國道路二段68號2樓2020-03-27有效
19耳鏡國械備20200119號精國醫(yī)療器材有限公司新北市蘆洲區(qū)國道路二段68號2樓2020-03-27有效
20種植用手術(shù)導(dǎo)板國械備20151335號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
21牙用尺國械備20150781號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
22螺絲起國械備20150871號???????(?)66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
23牙科種植定位器國械備20150799號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
24置骨器國械備20151366號Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
25膝關(guān)節(jié)手術(shù)工具國械備20200118號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Sri Trang Gloves (Thailand) Co., Ltd.109/2 Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2020-03-26變更
27打拔器國械備20150557號Smith & Nephew Orthopaedics AG Oberneuhofstrasse 10d 6340 Baar, Switzerland2020-03-26無效
28妊娠紋傷口護(hù)理軟膏包國械備20200117號LABORATOIRES FANNAMEX68 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ALTATEC GmbHMaybachstr. 5, 71299 Wimsheim, GERMANY2020-03-25變更
30負(fù)氣壓式骨折固定保護(hù)氣墊國械備20170145號OPED GmbHMedizinpark 1 83626 Valley/Oberlaindern GERMANY2020-03-25變更
31自動組織脫水機(jī)國械備20151900號Leica Biosystems Melbourne Pty Ltd495 Blackburn Road Mt Waverley Victoria 3149 Australia2020-03-24無效
32髖關(guān)節(jié)手術(shù)工具國械備20181628號Zimmer, Inc.1800 W. Center Street Warsaw Indiana 46580 USA2020-03-23變更
33造口皮膚保護(hù)劑國械備20190695號ConvaTec LimitedHickmans Road, Birkenhead, Wirral CH41 1JH United Kingdom2020-03-23變更
34造口護(hù)理用品國械備20200116號Welland Medical LimitedHydehurst Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2020-03-20有效
35創(chuàng)口貼國械備20200115號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1樓2020-03-20有效
36導(dǎo)引針國械備20200114號Search Medical Co., Ltd.16, Cheomdan venture so-ro 37 beon-gil, Buk-gu, Gwangju, Republic of Korea2020-03-20有效
37造口護(hù)理用品國械備20181323號ConvaTec Inc.Carretera Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic2020-03-19變更
38造口袋國械備20190171號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Riverstone Resources Sdn. Bhd.Lot 55＆56, No. 13, Jalan Jasmine 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung, Selangor, MALAYSIA2020-03-17變更
40干式激光成像儀國械備20170398號コニカミノルタ株式會社1 Sakura-machi，Hino-shi，Tokyo，Japan；2-2-1， Hirosedai，Sayama-shi，Saitama，Japan2020-03-16變更
41干式激光成像儀國械備20151260號コニカミノルタ株式會社埼玉県狹山市広瀬臺二丁目2番1號　2-2-1， Hirosedai，Sayama-shi，Saitama2020-03-16變更
42干式激光成像儀國械備20160861號コニカミノルタ株式會社2-2-1， Hirosedai，Sayama-shi，Saitama2020-03-16變更
43干式激光成像儀國械備20151259號コニカミノルタ株式會社埼玉県狹山市広瀬臺二丁目2番1號　2-2-1， Hirosedai，Sayama-shi，Saitama2020-03-16變更
44脊柱用手術(shù)工具國械備20200113號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HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2020-03-12變更
46轉(zhuǎn)移帽 國械備20170917號HumanTech Germany GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2020-03-12變更
47可調(diào)式固定支具國械備20151554號Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
48足托固定器國械備20151512號Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
49頸椎固定器國械備20151511號Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
50腰椎固定帶國械備20151510號Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
51醫(yī)用外固定支具國械備20151513號Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
52核酸提取或純化試劑國械備20200112號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 Singapore2020-03-11有效
53骨科手術(shù)器械國械備20200111號ORTHO-MEDICAL GmbHHauptstra?e 5 78589 Dürbheim Germany2020-03-11有效
54造口底盤國械備20200110號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牙科電動抽吸機(jī)國械備20200109號株式會社東京技研神奈川県橫浜市都筑區(qū)東山田4-42-372020-03-11有效
56口腔科手術(shù)器械國械備20200108號devemed GmbHtake-off GewerbePark 30  78579   Neuhausen ob ECK2020-03-10有效
57樣本稀釋液國械備20150466號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
58緩沖液國械備20150470號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
59緩沖液國械備20150464號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
60核酸提取試劑國械備20200107號倉敷紡績株式會社日本國大阪府寢屋川市下木田町14-52020-03-10有效
61樣本稀釋液國械備20200106號Ortho-Clinical Diagnostics, Inc.1000 Lee Road Rochester, New York 14606, USA2020-03-10有效
62樣本保存液國械備20200105號Copan Italia S. p. A.Via F. Perotti 18, 25125 Brescia, Italy; Via F. Perotti 10, 25125 Brescia, Italy2020-03-10有效
63CD2抗體試劑（免疫組織化學(xué)）國械備20190512號Dako Denmark A/S Produktionsvej 42, DK-2600 Glostrup, Denmark2020-03-10變更
64清洗液國械備20161828號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
65樣本稀釋液國械備20170463號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
66清洗液國械備20161827號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
67清洗液國械備20161812號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
68緩沖液國械備20170379號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
69樣本稀釋液國械備20161811號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
70緩沖液國械備20170378號Trinity Biotech(Primus Corporation dba Trinity Biotech)4231 E.75th Terrace Kansas City, Missouri, 64132, USA2020-03-10變更
71造口底盤國械備20181394號ConvaTec Inc.Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic2020-03-09變更
72造口袋國械備20190594號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ConvaTec LimitedWendenschlo?stra?e 142,12557 Berlin Deutschland2020-03-09變更
76造口減壓環(huán)國械備20151614號ConvaTec Limited1405 Dogwood Way, Mebrane, NC 27302, USA2020-03-09變更
77造口凸面嵌圈國械備20150925號ConvaTec LimitedCarretera 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SOS Surgical Co.Mughal Pura, Gohad Pur, Sialkot, Pakistan2020-03-06有效
79手術(shù)剪 國械備20200103號SOS Surgical Co.Mughal Pura, Gohad Pur, Sialkot, Pakistan2020-03-06有效
80鼻骨鑿國械備20200102號SOS Surgical Co.Mughal Pura, Gohad Pur, Sialkot, Pakistan2020-03-06有效
81口腔科手術(shù)器械國械備20200101號Helmut Zepf Medizintechnik GmbHHauptstraβe 60, 78606 Seitingen-Oberflacht, Germany2020-03-06有效
82髖關(guān)節(jié)手術(shù)器械國械備20161805號Smith & Nephew Orthopaedics AGSchachenalle 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?ssur hf.Grjotháls 1-5 Reykjavik 110 Iceland2020-03-06變更
84鈣石灰國械備20161369號Molecular Products LtdParkway, Harlow Business Park,  Harlow, CM19 5FR,  United Kingdom2020-03-06變更
85顯微剪國械備20190222號S&T AGTobelraastr.2, 8212 Neuhausen am Rheinfall, SWITZERLAND2020-03-04變更
86醫(yī)用檢查手套國械備20200100號Ever Global (Vietnam) Ent.Corp - Giang Dien FactoryNo 9 Street, Giang Dien Industrial Park, Trang Bom District, Dong Nai Province, VIETNAM2020-03-04有效
87修復(fù)重建顯微工具套裝國械備20190554號S&T AGTobelraastr.2, 8212 Neuhausen am Rheinfall, SWITZERLAND 2020-03-04變更
88兩件式造口袋國械備20140062號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BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
91拔牙鉗國械備20200098號BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
92手術(shù)剪國械備20200097號BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
93陰道牽開器國械備20200096號BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
94組織鑷國械備20200095號BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
95刮匙國械備20200094號BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
96核酸提取試劑國械備20200093號倉敷紡績株式會社日本國大阪府寢屋川市下木田町14-52020-03-03有效
97骨科手術(shù)器械國械備20200091號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Reskin Medical nv Ravenshout Z 5.2.50 3980 Tessenderio, Belgium2020-03-02變更
99呼吸訓(xùn)練器國械備20200090號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2020-03-02有效

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