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2022年5月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2022-06-20 19:02瀏覽次數(shù):2973次
2022年5月，藥監(jiān)總局共計(jì)批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案?事項(xiàng)93項(xiàng)，其中包括全自動(dòng)微生物樣本處理系統(tǒng)等第一類(lèi)醫(yī)療器械備案產(chǎn)品。詳見(jiàn)正文。

2022年5月，藥監(jiān)總局共計(jì)批準(zhǔn)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案事項(xiàng)93項(xiàng)，其中包括全自動(dòng)微生物樣本處理系統(tǒng)等第一類(lèi)醫(yī)療器械備案產(chǎn)品。詳見(jiàn)正文。

第一類(lèi)醫(yī)療器械產(chǎn)品備案.jpg

2022年5月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息

序號(hào)產(chǎn)品名稱(chēng)備案號(hào)備案人名稱(chēng)原文生產(chǎn)地址原文備案日期狀態(tài)
1全自動(dòng)微生物樣本處理系統(tǒng)國(guó)械備20220143號(hào)BD   Kiestra B.V.730   Fountain Street North- Building 2&3 Cambridge, ON N3H 4R7, Canada2022-05-31 有效
2牙科拋光條國(guó)械備20170122號(hào)株式會(huì)社ジーシーデンタルプロダクツ愛(ài)知県春日井市鳥(niǎo)居松町2丁目285番地2022-05-31 變更
3脊柱手術(shù)器械包國(guó)械備20160225號(hào)聯(lián)合骨科器材股份有限公司新竹市東區(qū)科學(xué)工業(yè)園區(qū)園區(qū)二路五十七號(hào)一樓2022-05-31 變更
4膝關(guān)節(jié)手術(shù)器械包國(guó)械備20160222號(hào)聯(lián)合骨科器材股份有限公司新竹市東區(qū)科學(xué)工業(yè)園區(qū)園區(qū)二路五十七號(hào)一樓2022-05-31 變更
5牙科種植用延長(zhǎng)器國(guó)械備20200258號(hào)ORNAGHI   LUIGI & C. S.n.c.Via   S. Margherita, 131 - 20861 BRUGHERIO (MB) - ITALIA2022-05-31 變更
6髖關(guān)節(jié)手術(shù)器械包國(guó)械備20152076號(hào)聯(lián)合骨科器材股份有限公司新竹市東區(qū)科學(xué)工業(yè)園區(qū)園區(qū)二路五十七號(hào)一樓2022-05-31 變更
7基礎(chǔ)外科手術(shù)器械國(guó)械備20220142號(hào)SURGICON   (PVT) LTDP.O.Box:No:244,Khadim   Ali Road,Sialkot-Pakistan2022-05-31 有效
8免疫組化抗原修復(fù)緩沖液   BOND Epitope Retrieval Solution 1國(guó)械備20150328   號(hào)Leica   Biosystems Newcastle LtdSecond   Avenue, Heatherhouse Industrial Estate, Irvine, KA12 8NB, United Kingdom2022-05-31 變更
9替代體國(guó)械備20190662號(hào)DENTIN   IMPLANTS TECHNOLOGIES LTDPO   Box no. 10，Migdal Tefen Industrial Park ，Zone2，24959, Israel2022-05-30 變更
10種植手術(shù)工具國(guó)械備20170621號(hào)DENTIN   Implants Technologies LtdMigdal   Tefen Industrial Park, Zone 2, P.O.B 10, 24959,Israel2022-05-30 變更
11氣腹針國(guó)械備20160500號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestrasse   4 78333 Stockach  Germany2022-05-30 變更
12口腔用其它器械國(guó)械備20160313號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestra?e   4 78333 Stockach  Germany2022-05-30 變更
13肛腸外科手術(shù)器械國(guó)械備20160854號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestrasse   4 78333 Stockach  Germany2022-05-30 變更
14顯微外科手術(shù)器械國(guó)械備20160312號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestra?e   4 78333 Stockach  Germany2022-05-30 變更
15組織鉗國(guó)械備20220141號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2022-05-27 有效
16持針鉗國(guó)械備20220140號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2022-05-27 有效
17樣本稀釋液   IMMULITE 1000 HCG Sample Diluent國(guó)械備20160268號(hào)Siemens   Healthcare Diagnostics Products LimitedGlyn   Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom2022-05-27 變更
18手動(dòng)推床國(guó)械備20161936號(hào)福順興科技有限公司臺(tái)南縣永康市東橋里中山南路471巷7弄9之6號(hào)1樓2022-05-26 變更
19基礎(chǔ)外科手術(shù)器械國(guó)械備20220139號(hào)ASIA   CARE + TECHPrem   Nagar Road, Sialkot Pakistan2022-05-26 有效
20神經(jīng)和心血管手術(shù)器械國(guó)械備20220138號(hào)ASIA   CARE + TECHPrem   Nagar Road, Sialkot Pakistan2022-05-26 有效
21牙科種植器械限深套國(guó)械備20220137號(hào)Osstem   Implant Co., Ltd.66-16，Bansong-ro   513beon-gil, Haeundae-gu, Busan, Korea2022-05-26 有效
22耳鼻喉科手術(shù)器械國(guó)械備20160604號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-05-25 變更
23耳鼻喉科手術(shù)器械包國(guó)械備20200361號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-05-25 變更
24手術(shù)刀國(guó)械備20181020號(hào)株式會(huì)社シャルマン福井県鯖江市川去町6-82022-05-25 變更
25空心鉆國(guó)械備20190162號(hào)Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany2022-05-24 變更
26螺絲起 國(guó)械備20170497號(hào)Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss, Deutschland2022-05-24 變更
27扭力扳手國(guó)械備20170499號(hào)Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss, Deutschland2022-05-24 變更
28牙科骨磨國(guó)械備20210248號(hào)Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss, Deutschland2022-05-24 變更
29骨科用電鋸片國(guó)械備20220135號(hào)MEDICON   eGG?ns?cker   15 78532 Tuttlingen GERMANY2022-05-24 有效
30種植體安裝輔助器械國(guó)械備20181501號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2022-05-24 變更
31泌尿肛腸科手術(shù)器械國(guó)械備20220134號(hào)ASIA   CARE + TECHPrem   Nagar Road, Sialkot Pakistan2022-05-24 有效
32婦產(chǎn)科手術(shù)器械國(guó)械備20220133號(hào)ASIA   CARE + TECHPrem   Nagar Road, Sialkot Pakistan2022-05-24 有效
33真空固定墊國(guó)械備20220132號(hào)KOHLBRAT&BUNZ   Gesellschaft m.b.hLoretostrasse   6–8, A-5550, Radstadt, Austria2022-05-24 有效
34腹部手術(shù)牽開(kāi)器國(guó)械備20152114號(hào)Integra   LifeSciences Corporation4900   Charlemar Dr.; Building A, Cincinnati, OH 45227, USA2022-05-24 變更
35腹部手術(shù)牽開(kāi)器國(guó)械備20160558號(hào)Integra   LifeSciences Corporation4900   Charlemar Dr., Building A, Cincinnati, OH 45227, USA2022-05-24 變更
36腹部手術(shù)牽開(kāi)器國(guó)械備20160469號(hào)Integra   LifeSciences Corporation4900   Charlemar Dr., Building A, Cincinnati, OH 45227, USA2022-05-24 變更
37顯微手術(shù)器械包國(guó)械備20161650號(hào)Integra   LifeSciences Production Corporation見(jiàn)型號(hào)附頁(yè)2022-05-24 變更
38神經(jīng)外科手術(shù)器械包國(guó)械備20170182號(hào)Integra   LifeSciences Production Corporation生產(chǎn)地址列表   Manufacturing site list.docx 2022-05-24 變更
39脊柱手術(shù)器械包國(guó)械備20170198號(hào)Integra   LifeSciences Production Corporation見(jiàn)型號(hào)附頁(yè)2022-05-24 變更
40手術(shù)用頭架國(guó)械備20160179號(hào)Integra   LifeSciences Corporation4900   Charlemar Dr., Building A, Cincinnati, OH 45227, USA2022-05-24 變更
41自動(dòng)染片機(jī)國(guó)械備20170935號(hào)Biocare   Medical,LLC.4040   Pike Lane, Concord, CA 94520, United States. 2022-05-23 變更
42耳鼻喉科手術(shù)器械國(guó)械備20161455號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-05-20 變更
43骨科手術(shù)器械國(guó)械備20220131號(hào)ASIA   CARE + TECHPrem   Nagar Road, Sialkot Pakistan2022-05-20 有效
44耳鼻喉科手術(shù)器械國(guó)械備20181443號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2022-05-20 變更
45耳鼻喉科手術(shù)器械國(guó)械備20160350號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestra?e   4 78333 Stockach  Germany2022-05-19 變更
46造口袋國(guó)械備20162055號(hào)Flexicare   Medical LtdCynon   Valley Business Park, Mountain Ash,Mid Glamorgan, CF45 4ER, UK2022-05-19 變更
47鼻用鉗國(guó)械備20171213號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestrasse   4 78333 Stockach  Germany2022-05-19 變更
48喉用手術(shù)器械國(guó)械備20161518號(hào)STEMA   Medizintechnik GmbHH.-E.-Bussestrasse   4 78333 Stockach  Germany2022-05-19 變更
49矯形外科（骨科）手術(shù)器械國(guó)械備20160580號(hào)Innomed,   Inc. 103   Estus Drive Savannah, Georgia, 31404,USA. 2022-05-18 變更
50全自動(dòng)樣品處理系統(tǒng)國(guó)械備20220130號(hào)株式會(huì)社エイアンドティー〒023-1101   巖手県奧州市江刺巖谷堂字松長(zhǎng)根63-22022-05-17 有效
51髖關(guān)節(jié)手術(shù)器械國(guó)械備20200250號(hào)Brainlab   AGOlof-Palme-Stra?e   9, 81829 München, Germany2022-05-16 變更
52肌電導(dǎo)聯(lián)線國(guó)械備20220129號(hào) Ambu A/SLot   171, Jalan PKNK 3/8, Kawasan Perusahaan Sungai Petani, 08000 Sungai Petani,   Kedah Darul Aman, Malaysia2022-05-16 有效
53組織染色機(jī)國(guó)械備20171002號(hào)サクラ精機(jī)株式會(huì)社長(zhǎng)野県千曲市大字鋳物師屋75番地の52022-05-12 變更
54冷凍切片機(jī)國(guó)械備20180494號(hào)サクラ精機(jī)株式會(huì)社長(zhǎng)野県千曲市大字鋳物師屋75番地の52022-05-12 變更
55包埋機(jī)國(guó)械備20181719號(hào)サクラ精機(jī)株式會(huì)社長(zhǎng)野県千曲市大字鋳物師屋75番地の52022-05-12 變更
56牙齦刀國(guó)械備20161986號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-11 變更
57骨刮匙國(guó)械備20160360號(hào)Innomed,   Inc.103   Estus Drive Savannah, Georgia, 31404,USA.2022-05-11 變更
58牙科用鑷國(guó)械備20170106號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-10 變更
59口角拉鉤國(guó)械備20161306號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-10 變更
60持針鉗國(guó)械備20161068號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-10 變更
61牙科用剪國(guó)械備20161307號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-10 變更
62牙齦分離器國(guó)械備20161065號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-10 變更
63牙刮匙國(guó)械備20162063號(hào)Storz   am Mark GmbHEmminger   Straβe 39, 78576 Emmingen-Liptingen Germany2022-05-10 變更
64醫(yī)用冷敷貼國(guó)械備20181629號(hào)德山製藥股份有限公司嘉義縣民雄鄉(xiāng)福樂(lè)村中山路38號(hào)2022-05-10 無(wú)效
65硅橡膠復(fù)制材料國(guó)械備20161887號(hào)Müller–Omicron   GmbH & Co. KGSchlosserstra?e   1,51789 Lindlar, Germany2022-05-10 變更
66胸腔心血管外科手術(shù)器械國(guó)械備20180406號(hào)Boss   Instruments Ltd.104   Sommerfield Drive,Gordonsville, VA22942,United States2022-05-10 變更
67骨科手術(shù)器械包國(guó)械備20191054號(hào)Innomed,   Inc.103   Estus Drive Savannah, Georgia, 31404,USA.2022-05-10 變更
68面中部和顱面骨創(chuàng)傷治療和重建手術(shù)工具包國(guó)械備20160728號(hào)維綱生物科技股份有限公司新竹縣湖口鄉(xiāng)鳳山村光復(fù)路58-1號(hào)3樓2022-05-10 變更
69醫(yī)用退熱貼 國(guó)械備20171169號(hào)新タック化成株式會(huì)社香川県三豊市豊中町上高野4148番地2022-05-09 變更
70口墊國(guó)械備20180645號(hào)Hager   & Werken GmbH & Co.KGAckerstra?e   1. D-47269 Duisburg Germany2022-05-09 變更
71橡皮障國(guó)械備20160654號(hào)HAGER   ＆ WERKEN GmbH & Co, KGAckerstr.   1 47269 Duisburg,Deutschland2022-05-09 變更
72菌斑顯示液 國(guó)械備20160587號(hào)Hager   & Werken GmbH & Co. KGAckerstr.   1 47269 Duisburg,Deutschland2022-05-09 變更
73吸唾管國(guó)械備20161144號(hào)Hager   & Werken GmbH & Co. KGAckerstraβe1.D-47269   Duisburg Germany2022-05-09 變更
74吸唾管國(guó)械備20161779號(hào)HAGER   ＆ WERKEN GmbH & Co, KGAckerstr.   1 47269 Duisburg,Deutschland2022-05-09 變更
75菌斑指示劑 國(guó)械備20151904號(hào)Hager   & Werken GmbH & Co. KGAckerstr.   1 47269 Duisburg,Deutschland2022-05-09 變更
76口角拉鉤國(guó)械備20151672號(hào)Hager   & Werken GmbH & Co. KGAckerstr.   1 47269 Duisburg Deutschland2022-05-09 變更
77牙科開(kāi)口器國(guó)械備20151659號(hào)Hager   & Werken GmbH & Co. KGAckerstr.   1 47269 Duisburg Deutschland2022-05-09 變更
78消毒刷國(guó)械備20161875號(hào)Hager   & Werken GmbH & Co. KGAckerstr.   1 47269 Duisburg,Deutschland2022-05-09 變更
79營(yíng)養(yǎng)瓊脂培養(yǎng)基國(guó)械備20220128號(hào)Liofilchem   S.r.l.Via   Uruguay, 64026 Roseto degli Abruzzi (TE), ITALY2022-05-09 有效
80CD25檢測(cè)試劑國(guó)械備20220127號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-05-07 有效
81CD71檢測(cè)試劑國(guó)械備20220126號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-05-07 有效
82CD71檢測(cè)試劑國(guó)械備20220125號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-05-07 有效
83CD2檢測(cè)試劑國(guó)械備20220124號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-05-07 有效
84CD127檢測(cè)試劑國(guó)械備20220123號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212022-05-07 有效
85DAB染色液國(guó)械備20220122號(hào)Agilent   Technologies, Inc.1170   Mark Ave.  Carpinteria, CA 93013 United   States2022-05-07 有效
86測(cè)瓣器套件國(guó)械備20210033號(hào)On-X   Life Technologies, Inc.1300   East Anderson Ln, Bldg B, Austin, Texas 78752, USA2022-05-07 變更
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