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國(guó)家局2024年9月批準(zhǔn)醫(yī)用射線防護(hù)用具等166個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)
發(fā)布日期:2024-10-14 22:19瀏覽次數(shù):149次
來自國(guó)家藥監(jiān)局2022年10月14日披露的數(shù)據(jù),2024年9月,國(guó)家藥監(jiān)局批準(zhǔn)醫(yī)用射線防護(hù)用具、冷凍包埋劑、耳鼻喉科用測(cè)量器、隔離套、硅橡膠復(fù)制材料等166個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng),一起來看更多內(nèi)容。

來自國(guó)家藥監(jiān)局2022年10月14日披露的數(shù)據(jù),2024年9月,國(guó)家藥監(jiān)局批準(zhǔn)醫(yī)用射線防護(hù)用具、冷凍包埋劑、耳鼻喉科用測(cè)量器、隔離套、硅橡膠復(fù)制材料等166個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng),一起來看更多內(nèi)容。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2024年9月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息(部分產(chǎn)品)

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醫(yī)用射線防護(hù)用具國(guó)械備20240338號(hào)SFXRAY   LIMITEDUnit   12, Agnes Street Industrial Estate, Agnes Street,  Belfast, BT13 1GB2024-09-30 有效
2冷凍包埋劑國(guó)械備20240033號(hào)SAKURA   FINETEK U.S.A., INC.1750   W 214th St TORRANCE, CA USA 905012024-09-30 變更
3耳鼻喉科用測(cè)量器國(guó)械備20240337號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A 6020 Innsbruck AUSTRIA2024-09-30 有效
4隔離套國(guó)械備20140134號(hào)Kaz   USA, Inc., A Helen of Troy Company11287   Kiley Drive, Huntley, IL 60142 United States2024-09-30 變更
5創(chuàng)口貼國(guó)械備20190713號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2024-09-30 無效
6創(chuàng)口貼國(guó)械備20190697號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2024-09-30 無效
7創(chuàng)口貼國(guó)械備20190644號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2024-09-30 無效
8創(chuàng)口貼國(guó)械備20190699號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2024-09-30 無效
9創(chuàng)口貼國(guó)械備20190645號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2024-09-30 無效
10創(chuàng)口貼國(guó)械備20190701號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2024-09-30 無效
11硅橡膠復(fù)制材料國(guó)械備20230326號(hào)プレミアムプラスジャパン株式會(huì)社〒561-0805大阪府豐中市原田南一丁目13番5號(hào)2024-09-30 變更
12牙探針國(guó)械備20240336號(hào)RISTEK   INSTRUMENTStreet   #7 Shahab Pura Road 51310 Sialkot,Pakistan2024-09-30 有效
13水門汀充填器國(guó)械備20240335號(hào)RISTEK   INSTRUMENTStreet   #7 Shahab Pura Road 51310 Sialkot,Pakistan2024-09-30 有效
14BCL-6   抗體試劑國(guó)械備20240334號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
15CD56   抗體試劑國(guó)械備20240333號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
16天冬氨酸蛋白酶(Napsin   A)抗體試劑國(guó)械備20240332號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
17CD138   抗體試劑國(guó)械備20240331號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
18腎母細(xì)胞瘤基因(WT1)抗體試劑國(guó)械備20240330號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
19SOX-11   抗體試劑國(guó)械備20240329號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
20上皮細(xì)胞粘附分子(Ep-CAM)抗體試劑國(guó)械備20240328號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
21巨細(xì)胞病毒(CMV)抗體試劑國(guó)械備20240327號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
22幽門螺旋桿菌   (Helicobacter pylori)抗體試劑國(guó)械備20240326號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
23AE1/AE3混合分子量角蛋白抗體試劑國(guó)械備20240325號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-29 有效
24乳牙成形冠套國(guó)械備20240324號(hào)frasaco   GmbH Oberhofer   Stra?e 18, 88069 Tettnang, Germany2024-09-29 有效
25一次性使用丁腈橡膠檢查手套國(guó)械備20140135號(hào)MULTISAFE   SDN.BHD. MULTISAFE SDN.BHD.Lot   764, Bidor Industrial Estate,35500 Bidor, Perak Darul Ridzuan, Malaysia2024-09-26 變更
26骨鋸保護(hù)套國(guó)械備20240318號(hào)Osstem   Implant Co., Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-26 變更
27螺絲起國(guó)械備20140285號(hào)Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden; 22715 Savi Ranch Parkway Yorba Linda California   92887 USA; Engvej 33, 3330 G?rl?se, Denmark; Wilhelmstraβe 19 78600 Kolbingen   Germany; Hanauer Straβe 5-7, 75181 Pforzheim.2024-09-26 變更
28流式細(xì)胞分析用鞘液國(guó)械備20170638號(hào)Becton,   Dickinson and Company, BD Biosciencesul.   Sowińskiego 11, 44-101 Gliwice, Poland2024-09-26 變更
29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.2024-09-25 變更
30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.2024-09-25 變更
31DOG1   抗體試劑國(guó)械備20240323號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-24 有效
32巨細(xì)胞病毒(CMV)抗體試劑國(guó)械備20240322號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA 2024-09-24 有效
33牙用充填器國(guó)械備20161112號(hào)Hu-Friedy   Mfg. Co., LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2024-09-24 變更
34牙骨鑿國(guó)械備20151353號(hào)Hu-Friedy   Mfg. Co., LLC美國(guó)伊利諾斯州芝加哥市北羅克韋爾大街3232號(hào)2024-09-24 變更
35牙用分離器國(guó)械備20151443號(hào)Hu-Friedy   Mfg. Co., LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2024-09-24 變更
36醫(yī)用橡膠檢查手套國(guó)械備20240123號(hào)PT.   UNIVERSAL GLOVESJI.   Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia2024-09-24 變更
37醫(yī)用橡膠檢查手套國(guó)械備20240122號(hào)PT.   UNIVERSAL GLOVESJI.   Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia2024-09-24 變更
38醫(yī)用退熱貼國(guó)械備20200442號(hào)新タツク化成株式會(huì)社/2024-09-24 無效
39牙科鑄造蠟國(guó)械備20240321號(hào)??????????   ??? ??? ???? 3?, 9-202024-09-23 有效
40基礎(chǔ)外科手術(shù)器械國(guó)械備20240320號(hào)S.R.R.   Surgical CompanyKotli   Behram, Airport Road, Sialkot, Pakistan2024-09-19 有效
41顯微外科手術(shù)器械包國(guó)械備20170541號(hào)Integra   LifeSciences Production Corporation/2024-09-19 變更
42基礎(chǔ)外科手術(shù)器械包國(guó)械備20171214號(hào)Integra   LifeSciences Production Corporation/2024-09-19 變更
43膝關(guān)節(jié)手術(shù)工具國(guó)械備20210189號(hào)DePuy   Ireland UC請(qǐng)見附件“生產(chǎn)地址”。2024-09-19 變更
44牙科種植手術(shù)工具包國(guó)械備20230478號(hào)MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea2024-09-19 變更
45醫(yī)用檢查手套國(guó)械備20240319號(hào)A   R MEDICOM (M) SDN. BHD.No.110   Kanjanavanit Road, Pahtong Hat Yai, Songkhla 90230 Thailand2024-09-19 有效
46骨鋸保護(hù)套國(guó)械備20240318號(hào)Osstem   Implant Co., Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 有效
47轉(zhuǎn)移帽國(guó)械備20160086號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
48口腔科陽性替換墊片國(guó)械備20180209號(hào)Osstem   Implant Co., Ltd.66-16,Bansong-ro   513beon-gil,Haeundae-gu,Busan,Korea2024-09-19 變更
49骨劈開工具盒-直國(guó)械備20161758號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
50種植體掃描體國(guó)械備20170627號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
51外提升工具盒國(guó)械備20161766號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
52骨劈開工具盒-彎國(guó)械備20161765號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
53位置定位器國(guó)械備20160011號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
54口腔科占位圈國(guó)械備20180205號(hào)Osstem   Implant Co., Ltd. 66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
55口腔科技工室用拋光保護(hù)帽國(guó)械備20190098號(hào)OSSTEM   IMPLANT Co., Ltd. 66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
56上頜竇提升器國(guó)械備20151367號(hào)Osstem   Implant Co., Ltd.66-16,Bansong-ro   513beon-gil,Haeundae-gu,Busan,Korea2024-09-19 變更
57種植體內(nèi)螺紋修復(fù)器國(guó)械備20191424號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea2024-09-19 變更
58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, Korea2024-09-19 變更
59牙科種植用延長(zhǎng)器國(guó)械備20191421號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea2024-09-19 變更
60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, Korea2024-09-19 變更
61γ-肌聚糖蛋白(Gamma   Sarcoglycan)抗體試劑國(guó)械備20240317號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-09-19 有效
62代型材料國(guó)械備20160324號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-09-19 變更
63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, Korea2024-09-19 變更
64肌營(yíng)養(yǎng)不良蛋白3(DYS3)抗體試劑國(guó)械備20240316號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-09-19 有效
65肌營(yíng)養(yǎng)不良蛋白2(DYS2)抗體試劑國(guó)械備20240315號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-09-19 有效
66肌營(yíng)養(yǎng)不良蛋白1(DYS1)抗體試劑國(guó)械備20240314號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-09-19 有效
67口腔觀察儀國(guó)械備20171139號(hào)Morpheus   Co.,Ltd.2F,   8, Daewangpangyo-ro395beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do2024-09-19 變更
68牙科石膏國(guó)械備20170140號(hào)dentona   AGOtto-Hahn-Straβe   27. D-44227 Dortmund   with the   branch  Am Kraftwerk Lippendorf.   D-04575 Neukieritzsch2024-09-19 變更
69丁腈檢查手套國(guó)械備20240313號(hào)PT   Universal GlovesJl.   Pertahanan No. 17, Patumbak Deli Serdang – Sumatera Utara (20361) Indonesia2024-09-18 有效
70口鏡國(guó)械備20200488號(hào)詠豪科技股份有限公司新竹縣竹北市新泰路31號(hào)8樓之12024-09-18 變更
71防霧口鏡國(guó)械備20200498號(hào)詠豪科技股份有限公司新竹縣竹北市新泰路31號(hào)8樓之12024-09-18 變更
72醫(yī)用檢查手套國(guó)械備20210316號(hào)PT.   UNIVERSAL GLOVESJI.   Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia2024-09-14 變更
73耳鏡國(guó)械備20190170號(hào)Welch   Allyn, Inc.4341   State Street Road, Skaneateles Falls, NY 13153, USA; Calle Emilio Flores   2471-A, Colonia Canon del Padre 22203 Tijuana, BC Mexico2024-09-14 變更
74雙目放大鏡國(guó)械備20240296號(hào)HOYA   TechnosurgicaI株式會(huì)社栃木県芳賀郡益子町大字塙858;   栃木県芳賀郡茂木町增井140番地12024-09-13 變更
75彈性纖維染色液國(guó)械備20220095號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson,AZ, 85755, United States 2024-09-12 變更
76彈性纖維染色液國(guó)械備20220094號(hào)Ventana   Medical Systems, Inc. 1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2024-09-12 變更
77種植輔助材料國(guó)械備20170167號(hào)Institut   Straumann AGPeter   Merian-Weg 12,4002 Basel,Switzerland; Les Champs du Clos 2,2613   Villeret,Switzerland; 60 Minuteman Road,Andover,MA,01810,USA2024-09-11 變更
78一次性使用口腔沖洗器國(guó)械備20150611號(hào)Intersurgical   LtdCrane   House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK2024-09-11 變更
79牙用尺國(guó)械備20171039號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-09-11 變更
80鉆針深度停止器國(guó)械備20240312號(hào)Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-09-11 有效
81生物顯微鏡國(guó)械備20220063號(hào)株式會(huì)社二コン244-8533 日本神奈川県橫浜市栄區(qū)長(zhǎng)尾臺(tái)町4712024-09-11 變更
82倒置生物顯微鏡國(guó)械備20230515號(hào)株式會(huì)社二コン471,   Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan2024-09-11 變更

由于文章篇幅限制,未列出全部166個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng),如需全部?jī)?nèi)容,歡迎您隨時(shí)方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò),聯(lián)系人:葉工,電話:18058734169,微信同。

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