醫(yī)療器械法規(guī)、注冊(cè)、臨床、體系認(rèn)證、信息系統(tǒng)一站式服務(wù)
24×7服務(wù)熱線：0571-86198618 簡(jiǎn)體中文 ENGLISH
關(guān)于我們
公司簡(jiǎn)介
聯(lián)系我們
聯(lián)系我們

公眾號(hào)二維碼.jpg

 聯(lián)系電話：0571-86198618手機(jī): 18058734169 (微信同)手機(jī):18868735317（微信同)周一至周日 8:00~22:00
在線客服周一至周日 8:00~22:00

QQ在線客服

 

當(dāng)前位置：網(wǎng)站首頁(yè)>關(guān)于我們>新聞動(dòng)態(tài)
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):3189次
2020年4月7日，國(guó)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(gè)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(guó)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(gè)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(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(guó)械備20170509號(hào)AIR TECHNIQUES INC 1295 Walt Whitman Road, Melville, NY 117472020-03-31變更
2牙科電動(dòng)空壓機(jī)國(guó)械備20171112號(hào)AIR TECHNIQUES INC1295 Walt Whitman Road, Melville, NY 117472020-03-31變更
3緩沖液國(guó)械備20200134號(hào)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(guó)械備20200133號(hào)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(guó)械備20200132號(hào)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(guó)械備20200131號(hào)Bioness Inc.25103 Rye Canyon Loop Valencia California 91355 USA2020-03-30有效
7軟骨壓碎器國(guó)械備20200130號(hào)devemed GmbHtake-off GewerbePark 30 78579 Neuhausen ob ECK2020-03-30有效
8緩沖液國(guó)械備20191203號(hào)Roche Diagnostics GmbHSandhofer Strasse 116,68305 Mannheim,Germany2020-03-30變更
9CD27檢測(cè)試劑(流式細(xì)胞儀法)國(guó)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
10CD41檢測(cè)試劑（流式細(xì)胞儀法）國(guó)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
11CD61檢測(cè)試劑（流式細(xì)胞儀法）國(guó)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
12IgG抗體檢測(cè)補(bǔ)充試劑盒（印跡法）國(guó)械備20200126號(hào)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(guó)械備20200125號(hào)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(guó)械備20200124號(hào)Anthogyr SAS2237 avenue André Lasquin, 74700 SALLANCHES FRANCE2020-03-27有效
15一件式造口袋國(guó)械備20200123號(hào)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(guó)械備20200122號(hào)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(guó)械備20200121號(hào)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(guó)械備20200120號(hào)精國(guó)醫(yī)療器材有限公司新北市蘆洲區(qū)國(guó)道路二段68號(hào)2樓2020-03-27有效
19耳鏡國(guó)械備20200119號(hào)精國(guó)醫(yī)療器材有限公司新北市蘆洲區(qū)國(guó)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(guó)械備20151335號(hào)Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
21牙用尺國(guó)械備20150781號(hào)Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
22螺絲起國(guó)械備20150871號(hào)???????(?)66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
23牙科種植定位器國(guó)械備20150799號(hào)Osstem Implant Co.,Ltd.66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2020-03-27變更
24置骨器國(guó)械備20151366號(hào)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(guó)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(guó)械備20170681號(hào)Sri Trang Gloves (Thailand) Co., Ltd.109/2 Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2020-03-26變更
27打拔器國(guó)械備20150557號(hào)Smith & Nephew Orthopaedics AG Oberneuhofstrasse 10d 6340 Baar, Switzerland2020-03-26無(wú)效
28妊娠紋傷口護(hù)理軟膏包國(guó)械備20200117號(hào)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(guó)械備20190350號(hào)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(guó)械備20170145號(hào)OPED GmbHMedizinpark 1 83626 Valley/Oberlaindern GERMANY2020-03-25變更
31自動(dòng)組織脫水機(jī)國(guó)械備20151900號(hào)Leica Biosystems Melbourne Pty Ltd495 Blackburn Road Mt Waverley Victoria 3149 Australia2020-03-24無(wú)效
32髖關(guān)節(jié)手術(shù)工具國(guó)械備20181628號(hào)Zimmer, Inc.1800 W. Center Street Warsaw Indiana 46580 USA2020-03-23變更
33造口皮膚保護(hù)劑國(guó)械備20190695號(hào)ConvaTec LimitedHickmans Road, Birkenhead, Wirral CH41 1JH United Kingdom2020-03-23變更
34造口護(hù)理用品國(guó)械備20200116號(hào)Welland Medical LimitedHydehurst Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2020-03-20有效
35創(chuàng)口貼國(guó)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(guó)械備20200114號(hào)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(guó)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 Republic2020-03-19變更
38造口袋國(guó)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(guó)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, MALAYSIA2020-03-17變更
40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，Japan2020-03-16變更
41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，Saitama2020-03-16變更
42干式激光成像儀國(guó)械備20160861號(hào)コニカミノルタ株式會(huì)社2-2-1， Hirosedai，Sayama-shi，Saitama2020-03-16變更
43干式激光成像儀國(guó)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，Saitama2020-03-16變更
44脊柱用手術(shù)工具國(guó)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(guó)械備20171123號(hào)HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2020-03-12變更
46轉(zhuǎn)移帽 國(guó)械備20170917號(hào)HumanTech Germany GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2020-03-12變更
47可調(diào)式固定支具國(guó)械備20151554號(hào)Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
48足托固定器國(guó)械備20151512號(hào)Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
49頸椎固定器國(guó)械備20151511號(hào)Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
50腰椎固定帶國(guó)械備20151510號(hào)Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
51醫(yī)用外固定支具國(guó)械備20151513號(hào)Orthobroker bvbaTer Stratenweg 11 - 2520 Ranst - Belgium2020-03-12變更
52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 Singapore2020-03-11有效
53骨科手術(shù)器械國(guó)械備20200111號(hào)ORTHO-MEDICAL GmbHHauptstra?e 5 78589 Dürbheim Germany2020-03-11有效
54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.2020-03-11有效
55牙科電動(dòng)抽吸機(jī)國(guó)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4-42-372020-03-11有效
56口腔科手術(shù)器械國(guó)械備20200108號(hào)devemed GmbHtake-off GewerbePark 30  78579   Neuhausen ob ECK2020-03-10有效
57樣本稀釋液國(guó)械備20150466號(hào)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(guó)械備20150470號(hào)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(guó)械備20150464號(hào)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(guó)械備20200107號(hào)倉(cāng)敷紡績(jī)株式會(huì)社日本國(guó)大阪府寢屋川市下木田町14-52020-03-10有效
61樣本稀釋液國(guó)械備20200106號(hào)Ortho-Clinical Diagnostics, Inc.1000 Lee Road Rochester, New York 14606, USA2020-03-10有效
62樣本保存液國(guó)械備20200105號(hào)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(guó)械備20190512號(hào)Dako Denmark A/S Produktionsvej 42, DK-2600 Glostrup, Denmark2020-03-10變更
64清洗液國(guó)械備20161828號(hào)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(guó)械備20170463號(hào)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(guó)械備20161827號(hào)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(guó)械備20161812號(hào)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(guó)械備20170379號(hào)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(guó)械備20161811號(hào)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(guó)械備20170378號(hào)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(guó)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 Republic2020-03-09變更
72造口袋國(guó)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(guó)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(guó)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(guó)械備20191032號(hào)ConvaTec LimitedWendenschlo?stra?e 142,12557 Berlin Deutschland2020-03-09變更
76造口減壓環(huán)國(guó)械備20151614號(hào)ConvaTec Limited1405 Dogwood Way, Mebrane, NC 27302, USA2020-03-09變更
77造口凸面嵌圈國(guó)械備20150925號(hào)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(guó)械備20200104號(hào)SOS Surgical Co.Mughal Pura, Gohad Pur, Sialkot, Pakistan2020-03-06有效
79手術(shù)剪 國(guó)械備20200103號(hào)SOS Surgical Co.Mughal Pura, Gohad Pur, Sialkot, Pakistan2020-03-06有效
80鼻骨鑿國(guó)械備20200102號(hào)SOS Surgical Co.Mughal Pura, Gohad Pur, Sialkot, Pakistan2020-03-06有效
81口腔科手術(shù)器械國(guó)械備20200101號(hào)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(guó)械備20161805號(hào)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(guó)械備20170278號(hào)?ssur hf.Grjotháls 1-5 Reykjavik 110 Iceland2020-03-06變更
84鈣石灰國(guó)械備20161369號(hào)Molecular Products LtdParkway, Harlow Business Park,  Harlow, CM19 5FR,  United Kingdom2020-03-06變更
85顯微剪國(guó)械備20190222號(hào)S&T AGTobelraastr.2, 8212 Neuhausen am Rheinfall, SWITZERLAND2020-03-04變更
86醫(yī)用檢查手套國(guó)械備20200100號(hào)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(guó)械備20190554號(hào)S&T AGTobelraastr.2, 8212 Neuhausen am Rheinfall, SWITZERLAND 2020-03-04變更
88兩件式造口袋國(guó)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(guó)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(guó)械備20200099號(hào)BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
91拔牙鉗國(guó)械備20200098號(hào)BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
92手術(shù)剪國(guó)械備20200097號(hào)BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
93陰道牽開器國(guó)械備20200096號(hào)BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
94組織鑷國(guó)械備20200095號(hào)BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
95刮匙國(guó)械備20200094號(hào)BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2020-03-03有效
96核酸提取試劑國(guó)械備20200093號(hào)倉(cāng)敷紡績(jī)株式會(huì)社日本國(guó)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(guó)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(guó)械備20180851號(hào)Reskin Medical nv Ravenshout Z 5.2.50 3980 Tessenderio, Belgium2020-03-02變更
99呼吸訓(xùn)練器國(guó)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

標(biāo)簽：醫(yī)療器械產(chǎn)品備案、一類醫(yī)療器械備案、醫(yī)療器械經(jīng)營(yíng)備案

Copyright © 2018 醫(yī)療器械注冊(cè)技術(shù)咨詢 浙ICP備18025678號(hào) 技術(shù)支持：熙和網(wǎng)絡(luò)

新聞動(dòng)態(tài)