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2021年6月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2021-07-08 23:25瀏覽次數(shù):7717次
2021年7月5日，藥監(jiān)總局發(fā)布2021年6月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息，6月共計(jì)批準(zhǔn)124個(gè)進(jìn)口一類備案產(chǎn)品。一起來看看有哪些進(jìn)口一類產(chǎn)品。

引言：2021年7月5日，藥監(jiān)總局發(fā)布2021年6月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息，6月共計(jì)批準(zhǔn)124個(gè)進(jìn)口一類備案產(chǎn)品。一起來看看有哪些進(jìn)口一類產(chǎn)品。

第一類醫(yī)療器械產(chǎn)品備案.jpg

2021年06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人體定位袋國械備20161113號(hào)MEDTEC.   Inc.1401   8TH ST. S.E. Orange City, IA USA 510412021-06-29 變更
2人體定位袋國械備20181007號(hào)MEDTEC,Inc.1401   8TH ST. S.E. Orange City, IA USA 510412021-06-29 變更
3人體定位袋國械備20180866號(hào)MEDTEC,Inc.1401   8th St.SE,Orange City,IA,51041,United States2021-06-29 變更
4種植體安裝輔助器械國械備20210339號(hào)CSM   Implant35,   Seongjusaneopdanji-ro, Seongju-eup, Seongju-gun, Gyeongsangbuk-do,40031, Rep.   of KOREA2021-06-29 有效
5清洗液國械備20151713號(hào)Roche   Diagnostics GmbH1080   US Highway 202 South, Branchburg, NJ 08876, USA2021-06-24 變更
6樣本稀釋液國械備20151712號(hào)Roche   Diagnostics GmbH1080   US Highway 202 South, Branchburg, NJ 08876, USA2021-06-24 變更
7超聲潔牙機(jī)工作尖國械備20210338號(hào)E.M.S.   Electro Medical Systems S.A.Rte.   de Champ-Colin 2, 1260 Nyon, Switzerland2021-06-24 有效
8口腔治療器具國械備20210337號(hào)DADDY   D PROHigh   Rise Building, Dhattal Stop, Ugoki Adalat Garh Road, Sialkot-Pakistan2021-06-24 有效
9快裝手柄國械備20152128號(hào)Waldemar   Link GmbH & Co. KGBarkhausenweg   10 22339 Hamburg GERMANY2021-06-22 變更
10核酸提取或純化試劑國械備20181608號(hào)QIAGEN   GmbHQIAGEN   Strasse 1, 40724 Hilden , Germany2021-06-22 變更
11ALK抗體試劑（免疫組織化學(xué)）國械備20190295號(hào) Leica Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2021-06-22 無效
12蘇木素染色液國械備20151600號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2021-06-22 無效
13樣本處理血清指數(shù)試劑（分光光度法）國械備20210336號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116 , 68305 Mannheim，Germany2021-06-22 有效
14髖臼杯系統(tǒng)手術(shù)工具國械備20210176號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg Germany2021-06-22 變更
15彈性繃帶國械備20180674號(hào)Kowa   Company Ltd.1619,   Yamaguchi, Kouhoku-machi, Kishima-gun, Saga-Ken 849-0501 Japan2021-06-22 變更
16持針鉗國械備20210335號(hào)株式會(huì)社ナイツ〒389-0601　長野県埴科郡坂城町坂城6249；長野縣茅野市茅野624-1   2樓2021-06-22 有效
17LED手術(shù)照明燈國械備20210334號(hào)Sunoptic   Technologies, LLC6018   Bowdendale Avenue, Jacksonville, FL 32216, USA2021-06-21 有效
18可調(diào)式固定支具國械備20151554號(hào)Orthobroker   bvbaTer   Stratenweg 11 - 2520 Ranst - Belgium2021-06-21 變更
19腰椎固定帶國械備20151510號(hào)Orthobroker   bvbaTer   Stratenweg 11 - 2520 Ranst - Belgium2021-06-21 變更
20醫(yī)用外固定支具國械備20151513號(hào)Orthobroker   bvbaTer   Stratenweg 11 - 2520 Ranst - Belgium2021-06-21 變更
21脫脂脫鈣儀國械備20210333號(hào)株式會(huì)社   常光靜岡県菊川市西   1542021-06-21 有效
22造口袋國械備20190948號(hào)Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2021-06-21 變更
23牙科種植專用器械包國械備20162056號(hào)BEGO   Implant Systems GmbH & Co. KGWilhelm-Herbst-Str.1,   28359 Bremen, Deutschland2021-06-21 變更
24牙科種植手術(shù)修復(fù)工具包國械備20160873號(hào)BEGO   Implant Systems GmbH & Co. KGWilhelm-Herbst-Str.1,   28359 Bremen, Deutschland2021-06-21 變更
25清洗液國械備20210332號(hào)IMMUNODIAGNOSTIC   SYSTEMS S.A.Rue   Ernest Solvay 101 4000 LIEGE BELGIUM2021-06-18 有效
26清洗液國械備20210331號(hào)IMMUNODIAGNOSTIC   SYSTEMS S.A.Rue   Ernest Solvay 101 4000 LIEGE BELGIUM2021-06-18 有效
27X射線防護(hù)裝置國械備20181414號(hào)Kenex   (Electro-Medical) LtdUnit   17, RO24 Greenway, Harlow Business Park, Harlow, Essex, CM19 5QB,UK2021-06-17 變更
28全自動(dòng)血沉分析儀國械備20210330號(hào)ALIFAX   S.r.l.Via   Merano 30 33045 Nimis (UD) Italy2021-06-16 有效
29基礎(chǔ)外科手術(shù)器械國械備20210329號(hào)SAHIL   SURGICAL (PVT) LIMITEDNoul   More, Roras Road, Sialkot-51310 Pakistan2021-06-16 有效
30免疫顯色試劑   BOND Polymer Refine Red Detection國械備20150984號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2021-06-16 變更
31創(chuàng)口貼國械備20210328號(hào)/2579-2,   Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of   Korea2021-06-16 有效
32導(dǎo)航手術(shù)工具國械備20181147號(hào)Medtronic   Sofamor Danek USA, Inc.4340   Swinnea Road, Memphis, TN 38118, USA2021-06-16 變更
33脊柱用手術(shù)工具國械備20150294號(hào)Medtronic   Sofamor Danek USA, Inc.4340   Swinnea Road, Memphis TN 38118, USA2021-06-16 變更
34手術(shù)頭架國械備20210327號(hào)DIMEDA   Instrumente GmbHG?ns?cker   54+58, 78532 Tuttlingen, GERMANY2021-06-16 有效
35正畸鉗國械備20160365號(hào)3M   Unitek Corporation見附件。2021-06-15 變更
36醫(yī)用射線防護(hù)用具國械備20210326號(hào)WSR   Medical Solutions LTDUnit   E Bridgewater Close, Network 65 Business Park, Hapton,Burnley, BB11 5TE2021-06-15 有效
37手術(shù)放大鏡國械備20151134號(hào)Rudolf   Riester GmbHClewer   Hill Road, Windsor, Berkshire SL4 4AA, United Kingdom2021-06-15 變更
38頭戴式檢查燈國械備20190369號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2021-06-15 變更
39 二用聽診器 國械備20150317號(hào)Rudolf   Riester GmbHBruckstraβe   31 72417 Jungingen, Germany2021-06-15 變更
40檢耳鏡國械備20180752號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2021-06-15 變更
41耳鏡國械備20190791號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2021-06-15 變更
42雙翼陰道擴(kuò)張器國械備20160356號(hào)Rudolf   Riester GmbHSmall   Industrial Estate, Sialkot-Pakistan2021-06-15 變更
43聽覺檢查音叉國械備20170546號(hào)Rudolf   Riester GmbHBruckstra?e   31, 72417 Jungingen, Germany2021-06-15 變更
44醫(yī)用檢查燈國械備20190355號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2021-06-15 變更
45電動(dòng)移位機(jī)國械備20210325號(hào)Winncare   Nordic ApST?rnborgvej   12c, 4220 Kors?r, Denmark2021-06-15 有效
46醫(yī)用離心機(jī)國械備20180068號(hào)DiaMed   GmbHPra   Rond 23, 1785 Cressier FR, SWITZERLAND2021-06-11 變更
47孵育器國械備20171203號(hào)DiaMed   GmbHPra   Rond 23, 1785 Cressier FR, SWITZERLAND2021-06-11 變更
48電動(dòng)移位機(jī)國械備20190552號(hào)ArjoHuntleigh   AB2001,   rue Tanguay Magog Québec J1X 5Y5 Canada2021-06-11 變更
49外科牽開器國械備20151483號(hào)LandangerZI   La Vendue,FR-52906 Chaumont Cedex 92021-06-11 變更
50吸引管國械備20151482號(hào)LandangerZI   La Vendue,FR-52906 Chaumont Cedex 92021-06-11 變更
51咬骨鉗國械備20151485號(hào)LandangerZI   La Vendue,FR-52906 Chaumont Cedex 92021-06-11 變更
52組織鑷國械備20151484號(hào)LandangerZI   La Vendue,FR-52906 Chaumont Cedex 92021-06-11 變更
53牙科種植掃描體國械備20191124號(hào)ARUM   DENTISTRY Co., Ltd.1-dong,   44, Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea2021-06-10 變更
54膽道探條國械備20190926號(hào)OpInstruments   GmbHBessemerstrasse   7 Frankfurt am Main 60388 Germany2021-06-10 變更
55鉗式牽開器國械備20150686號(hào)OpInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
56組織拉鉤 國械備20150713 號(hào)OPInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main，Germany2021-06-10 變更
57顯微組織鑷國械備20150705號(hào)OpInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main，Germany2021-06-10 變更
58止血鉗國械備20150706號(hào)OPInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main，Germany2021-06-10 變更
59顯微止血夾國械備20150716號(hào)OPInstruments   GmbHFriedrich-Ebert-Anlage   36,Frankfurt am Main，Germany2021-06-10 變更
60剝離器國械備20190928號(hào)OpInstruments   GmbHBessemerstrasse   7 Frankfurt am Main 60388 Germany2021-06-10 變更
61螺絲起國械備20150871號(hào)???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-06-10 變更
62醫(yī)用剪國械備20150704號(hào)/Friedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
63組織鑷國械備20150715號(hào)/Friedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
64咬骨鉗國械備20150717號(hào)/Friedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
65手術(shù)輔助照明燈國械備20190890號(hào)OpInstruments   GmbHBessemerstrasse   7 Frankfurt am Main 60388 Germany2021-06-10 變更
66雙目手術(shù)放大鏡國械備20150719號(hào)/Friedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
67吸引管國械備20150718號(hào)OpInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
68顯微持針鉗國械備20150702號(hào)OpInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
69顯微剪國械備20150703號(hào)OPInstruments   GmbHFriedrich-Ebert-Anlage   36, Frankfurt am Main，Germany2021-06-10 變更
70拉鉤裝置器國械備20150714號(hào)OpInstruments   GmbHFriedrich-Ebert-Anlage   36,Frankfurt am Main，Germany2021-06-10 變更
71彈性繃帶國械備20151862號(hào)/Friedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-10 變更
72持針鉗國械備20150701號(hào)OPInstruments   GmbH弗里德里希-艾伯特園區(qū)   36號(hào)，60325美茵河畔法蘭克福，德國2021-06-10 變更
73打孔器國械備20190992號(hào)Bessemerstrasse   7 Frankfurt am Main 60388 GermanyBessemerstrasse   7 Frankfurt am Main 60388 Germany2021-06-10 變更
74根管充填器國械備20160554號(hào)Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA2021-06-09 變更
75站立架國械備20210324號(hào)James   Leckey Design LtdBallinderry   Road, Lisburn, Antrim BT28 2SA United Kingdom2021-06-09 有效
76助行器國械備20210323號(hào)James   Leckey Design LtdBallinderry   Road, Lisburn, Antrim BT28 2SA United Kingdom2021-06-09 有效
77 鉆石手術(shù)刀國械備20210322號(hào)Amidia   AGMattenstrasse   11 2555 Brügg BE Switzerland  2021-06-09 有效
78血壓袖帶國械備20170390號(hào)日本光電工業(yè)株式會(huì)社千葉県市原市八幡海岸通1969-33、34 2021-06-08 變更
79結(jié)扎鉗國械備20190927號(hào)OpInstruments   GmbHBessemerstrasse   7 Frankfurt am Main 60388 Germany2021-06-08 變更
80外科牽開器國械備20150688號(hào)OPInstruments   GmbHFriedrich-Ebert-Anlage   36,Frankfurt am Main，Germany2021-06-08 變更
81醫(yī)用頭燈國械備20190889號(hào)OpInstruments   GmbHBessemerstrasse   7 Frankfurt am Main 60388 Germany2021-06-08 變更
82手術(shù)刀國械備20150685號(hào)/Friedrich-Ebert-Anlage   36, Frankfurt am Main, Germany2021-06-08 變更
83醫(yī)用射線防護(hù)簾國械備20210321號(hào)????   ????????????   ??? ????60?? 332021-06-07 有效
84醫(yī)用射線防護(hù)簾國械備20210320號(hào)????   ????????????   ??? ????60?? 332021-06-07 有效
85醫(yī)用射線防護(hù)簾國械備20210319號(hào)????   ????????????   ??? ????60?? 332021-06-07 有效
86種植體掃描體國械備20171183號(hào)Sirona   Dental Systems GmbHFabrikstr.31,   64625 Bensheim, GERMANY2021-06-07 變更
87醫(yī)用退熱貼 國械備20161744號(hào)3M   Thailand Limited53/1   Soi Sukhapiban2, Tambol Rahaeng, Amphur Lardloomkaew, Pathumthani 12140,   Thailand2021-06-07 變更
88醫(yī)用固定帶國械備20181489號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
89醫(yī)用退熱貼 國械備20180167號(hào)3M   Thailand Limited53/1   Soi Sukhapiban 2, Tambol Rahaeng Amphur Lardloomkaew, Pathumthani 12140   THAILAND2021-06-07 變更
90上肢醫(yī)用外固定支具國械備20150354號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
91下肢醫(yī)用外固定支具國械備20150357號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
92腕部固定帶國械備20181491號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
93頸托國械備20150355號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
94肘關(guān)節(jié)固定帶國械備20181511號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
95下肢支具國械備20181490號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
96疝脫支撐器國械備20140070號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
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98手臂吊帶國械備20140113號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2021-06-07 變更
99脊柱微創(chuàng)手術(shù)器械國械備20210318號(hào)Best   medical GmbHHeudorfer   Straβe 32 78576 Emmingen-Liptingen Germany2021-06-04 有效
100口腔科手術(shù)器械國械備20210317號(hào)CORNERSTONE   CORPORATIONNai   Abadi，Bhoth，Church Street，Sialkot-51310-Pakistan2021-06-04 有效
101干式成像儀國械備20200497號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt Austria2021-06-04 變更
102檢查手套國械備20210316號(hào)PT.   UNIVERSAL GLOVESJI.   Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia2021-06-04 有效
103檢查手套國械備20210315號(hào)QUBE   MEDICAL PRODUCTS SDN. BHD.No   9, Jalan KPK 1/3, Kawasan Perindustrian Kundang, Kundang Jaya, Selangor   48020, Malaysia.2021-06-04 有效
104上釘器國械備20210314號(hào)Medos   International SARL50   Scotland Blvd, Bridgewater Massachusetts, 02324 USA2021-06-04 有效
105熱敏打印機(jī)國械備20210313號(hào)ソニー株式會(huì)社靜岡県湖西市境宿５５４2021-06-04 有效
106熱敏打印機(jī)國械備20210312號(hào)ソニー株式會(huì)社靜岡県湖西市境宿５５４2021-06-04 有效
107醫(yī)用干式激光膠片國械備20200496號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt Austria 2021-06-03 變更
108醫(yī)用干式激光膠片國械備20200495號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt    Austria2021-06-03 變更
109骨關(guān)節(jié)手術(shù)器械國械備20210311號(hào)T.A.G.   Medical Products Corporation Ltd.Kibbutz   Gaaton 2513000 Israel2021-06-03 有效
110腹部牽開器國械備20210310號(hào)高砂醫(yī)科工業(yè)株式會(huì)社千葉県柏市柏インター東5-11、12、132021-06-03 有效
111心電導(dǎo)聯(lián)線國械備20210309號(hào)GETEMED   Medizin- und Informationstechnik AGOderstr.77,   14513 Teltow, Deutschland2021-06-03 有效
112醫(yī)用干式激光膠片國械備20200490號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt Austria2021-06-03 變更
113干式成像儀國械備20200499號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt Austria 2021-06-03 變更
114醫(yī)用干式激光膠片國械備20200492號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt Austria2021-06-03 變更
115醫(yī)用干式激光膠片國械備20200500號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt Austria2021-06-03 變更
116醫(yī)用干式激光膠片國械備20200501號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117 2700 Wiener Neustadt    Austria2021-06-03 變更
117冷敷凝膠國械備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)2021-06-03 有效
118冷敷凝膠國械備20210307號(hào)達(dá)文西生醫(yī)科技股份有限公司屏東縣屏東市清溪裏和生路三段1006號(hào)2021-06-03 有效
119液體敷料國械備20210306號(hào)達(dá)文西生醫(yī)科技股份有限公司屏東縣屏東市清溪裏和生路三段1006號(hào)2021-06-03 有效
120樣本稀釋液   ARCHITECT Progesterone Manual Diluent 國械備20170559號(hào)Abbott   Ireland Diagnostics DivisionLisnamuck,   Longford, Co. Longford, Ireland2021-06-03 變更
121熱敏膠片國械備20210305號(hào)ソニー株式會(huì)社兵庫県尼崎市常光寺4-3-12021-06-03 有效
122種植體定位器國械備20210301號(hào)Forum   Engineering Technologies (96), Ltd40 Hutsot Hayotser St., P. O. Box 3095 Ashkelon 7878563, Israel2021-06-02 有效
123手術(shù)輔助照明燈國械備20210300號(hào)株式會(huì)社ナイツ〒389-0601　長野県埴科郡坂城町坂城62492021-06-02 有效
124代型材料國械備20180662號(hào)Dentsply   Sirona570   West College Avenue York Pennsylvania 17401 USA2021-06-01 變更


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