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當(dāng)前位置：網(wǎng)站首頁(yè)>新聞動(dòng)態(tài) >國(guó)家局7月批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案133項(xiàng)
國(guó)家局7月批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案133項(xiàng)
發(fā)布日期:2024-08-12 20:05瀏覽次數(shù):318次
來(lái)自國(guó)家藥監(jiān)局2024年8月12日披露的數(shù)據(jù)，2024年7月，國(guó)家局批準(zhǔn)螺絲起、上頜竇提升工具包、牙科手術(shù)工具包、種植體掃描體、光固化牙齦屏障樹(shù)脂、橡皮障器械包、全自動(dòng)電泳儀、樣本稀釋液、 DAPI染色液等進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)113項(xiàng)，一起看正文。

來(lái)自國(guó)家藥監(jiān)局2024年8月12日披露的數(shù)據(jù)，2024年7月，國(guó)家局批準(zhǔn)螺絲起、上頜竇提升工具包、牙科手術(shù)工具包、種植體掃描體、光固化牙齦屏障樹(shù)脂、橡皮障器械包、全自動(dòng)電泳儀、樣本稀釋液、 DAPI染色液等進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)113項(xiàng)，一起看正文。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2024年7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螺絲起國(guó)械備20162054號(hào)Neobiotech   Co., Ltd.104,   24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36,   Digital-ro 27-gil, Guro-gu, Seoul, KOREA2024-07-31 變更
2上頜竇提升工具包國(guó)械備20170091號(hào)Neobiotech   Co., Ltd.104,   24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36,   Digital-ro 27-gil, Guro-gu, Seoul, KOREA2024-07-31 變更
3牙科手術(shù)工具包國(guó)械備20170092號(hào)Neobiotech   Co., Ltd.104,   24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36,   Digital-ro 27-gil, Guro-gu, Seoul, KOREA2024-07-31 變更
4種植體掃描體國(guó)械備20170029號(hào)Neobiotech   Co., Ltd.104,   24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36,   Digital-ro 27-gil, Guro-gu, Seoul, KOREA2024-07-31 變更
5橡皮障 國(guó)械備20151345號(hào)SANCTUARY   HEALTH SDN BHDNo.16,   Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia2024-07-31 變更
6光固化牙齦屏障樹(shù)脂國(guó)械備20230285號(hào)SANCTUARY   HEALTH SDN. BHD.No.16,   Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia.2024-07-31 變更
7橡皮障器械包國(guó)械備20180036號(hào)SANCTUARY   HEALTH SDN BHD57,   Hwanggeum-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2024-07-31 變更
8全自動(dòng)電泳儀國(guó)械備20180488號(hào)株式會(huì)社ヘレナ研究所9-21-19   Tokiwa, Urawa-ku, Saitama-shi, Saitama 330-0061 JAPAN2024-07-30 變更
9樣本稀釋液國(guó)械備20230198號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim,Germany2024-07-30 變更
10 DAPI染色液國(guó)械備20240253號(hào)Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands 2024-07-30 有效
11DAPI染色液國(guó)械備20240252號(hào)Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands 2024-07-30 有效
12血小板振蕩器國(guó)械備20191384號(hào)Helmer   Inc.14400   Bergen Boulevard Noblesville, IN 46060 USA2024-07-29 變更
13口腔隔離器具國(guó)械備20170181號(hào)(?)??42-25,   Dongsan-Ro 27beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea Rep.2024-07-29 變更
14口角拉鉤國(guó)械備20240251號(hào)株式會(huì)社デンテック東京都板橋區(qū)清水町５３－５2024-07-26 有效
15穴位壓力刺激貼國(guó)械備20240250號(hào)(?)??????   ??? ??? ???? 146 M ? 3 ?2024-07-26 有效
16牙科拋光磨頭國(guó)械備20240249號(hào)Ultradent   Products, Inc.Neureutstr.6,   75210 Keltern, Germany2024-07-25 有效
17牙科種植手術(shù)工具國(guó)械備20240248號(hào)Evidence   implant Inc.32,Innovalley-ro,   Dong-gu, Daegu, 41065, Republic of Korea 2024-07-25 有效
18耳用鉆孔定位工具包國(guó)械備20240247號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A 6020 Innsbruck AUSTRIA2024-07-25 有效
19組織脫水機(jī)國(guó)械備20230586號(hào)Milestone   S.r.l.Via   Fatebenefratelli, 1/5 24010 SORISOLE (BG) Corso Europa Unita, 6 IT – 24030   VALBREMBO (BG) 2024-07-25 變更
20沖洗緩沖液V國(guó)械備20190667號(hào)Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands2024-07-25 變更
21前處理緩沖液B國(guó)械備20190668號(hào)Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands2024-07-25 變更
22FOXO1（13q14）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20230488號(hào)Kreatech   Biotechnology B.V. Vlierweg 20, 1032 LG Amsterdam, The   Netherlands2024-07-25 變更
23EGFR（7p11）/   SE7（D7Z1）基因擴(kuò)增探針試劑（熒光原位雜交法）國(guó)械備20230441號(hào)Kreatech   Biotechnology B.V. Vlierweg 20, 1032 LG Amsterdam, The   Netherlands2024-07-25 變更
24BCL2   (18q21)基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20220257號(hào)Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands2024-07-25 變更
25TOP2A基因擴(kuò)增探針試劑（原位雜交法）國(guó)械備20181383號(hào)//2024-07-25 變更
26微波組織脫水機(jī)國(guó)械備20230153號(hào)Milestone   S.r.l.Via   Fatebenefratelli, 1/5IT-24010 Sorisole (BG) Corso Europa,6 IT-24030 Valbrembo   (BG)2024-07-25 變更
27Ki-67抗體試劑國(guó)械備20240246號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-07-25 有效
28Ki-67抗體試劑國(guó)械備20240245號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-07-25 有效
29免疫顯色試劑國(guó)械備20181469號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-07-25 變更
30固定器國(guó)械備20200587號(hào)Julius   Zorn GmbH見(jiàn)附件2024-07-24 變更
31壓力繃帶國(guó)械備20200050號(hào)Julius   Zorn GmbH見(jiàn)附件2024-07-24 變更
32AE1/AE3混合分子量角蛋白抗體試劑國(guó)械備20240244號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-07-24 有效
33AMACR抗體試劑國(guó)械備20240243號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-07-24 有效
34壓力繃帶國(guó)械備20220066號(hào)Julius   Zorn GmbH見(jiàn)附件2024-07-24 變更
35壓力繃帶國(guó)械備20230597號(hào)SIGVARIS   AGGr?blistrasse   8，CH-9014 St. Gallen，Switzerland2024-07-24 變更
36口腔燈國(guó)械備20171071號(hào)FARO   SPAVIA   FARO 15-20876 ORNAGO (MB)2024-07-24 變更
37牙科器械鉗國(guó)械備20220356號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
38牙科成形片套裝國(guó)械備20220364號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
39牙科成形片套裝國(guó)械備20220370號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
40牙科成形片套裝國(guó)械備20220355號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
41口內(nèi)塑形刀套裝國(guó)械備20220351號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
42牙科測(cè)量桿國(guó)械備20220350號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
43牙科測(cè)量桿國(guó)械備20220349號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
44牙科器械鉗國(guó)械備20220359號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
45牙科用鑷國(guó)械備20220371號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
46牙科成形片套裝國(guó)械備20220372號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
47成形片夾國(guó)械備20220367號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
48成形片國(guó)械備20220233號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-07-23 變更
49口腔科手術(shù)器械國(guó)械備20240242號(hào)SLOKI   SURGICALSublime   Chowk,Wazirabad Road,Gujjar Town,Sialkot-Pakistan2024-07-23 有效
50種植體植入手術(shù)器械包國(guó)械備20170276號(hào)Zimmer   Dental, Inc.1900   Aston Avenue, Carlsbad, CA 92008, USA2024-07-23 變更
51清洗液國(guó)械備20151416號(hào)Medica   Corporation5   Oak Park Drive, Bedford, Massachusetts 01730 USA2024-07-22 變更
52尿液分析用稀釋液國(guó)械備20210451號(hào)Medica   Corporation5   Oak Park Drive, Bedford, Massachusetts, 01730, United States2024-07-22 變更
53樣本稀釋液國(guó)械備20151244號(hào)日本電子株式會(huì)社茨城県龍ヶ崎市向陽(yáng)臺(tái)三丁目3番1號(hào)   3-1, Koyodai 3-chome, Ryugasaki-shi, Ibaraki 301-0852 Japan2024-07-22 變更
54牙用尺 國(guó)械備20180520號(hào)Alpha-Bio   Tec Ltd7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2024-07-22 變更
55TERC基因擴(kuò)增探針試劑（原位雜交法）國(guó)械備20181384號(hào)//2024-07-19 變更
56WT1（11p13）基因斷裂探針試劑（熒光原位雜交法）國(guó)械備20240241號(hào)ZytoVision   GmbHFischkai   1, 27572 Bremerhaven, Deutschland2024-07-19 有效
57口腔科手術(shù)器械國(guó)械備20240240號(hào)NIBBLE   SURGICALAbyala，P/O   Box Dholo Bhelo，Sialkot-Pakistan2024-07-19 有效
58無(wú)針注射推進(jìn)器國(guó)械備20170999號(hào)呈汝生物科技股份有限公司高雄市左營(yíng)區(qū)大順一路91號(hào)5樓之62024-07-18 變更
59子彈型光固化樹(shù)脂輸送器國(guó)械備20240239號(hào)Ultradent   Products, Inc.770   River Road, Shelton, CT 06484, USA2024-07-17 有效
60固定用彈力束帶國(guó)械備20230169號(hào) Bauerfeind AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2024-07-17 變更
61雄激素受體（AR）抗體試劑國(guó)械備20240238號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2024-07-17 有效
62p40抗體試劑國(guó)械備20240237號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2024-07-17 有效
63平足蛋白（Podoplanin）抗體試劑 國(guó)械備20240236號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2024-07-17 有效
64特異AT序列結(jié)合蛋白2（SATB2）抗體試劑國(guó)械備20240235號(hào)Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2024-07-17 有效
65轉(zhuǎn)移帽國(guó)械備20180560號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St.,Kiryat Arye,POB 3936 Petach Tikva,4951025,Israel2024-07-17 變更
66人體定位袋國(guó)械備20190114號(hào)MEDTEC,Inc.1401   8th St.SE,Orange City,IA,51041,United States2024-07-17 無(wú)效
67醫(yī)用圖像打印機(jī)國(guó)械備20200686號(hào)Agfa   NVMax-Planck-Str.   1, 82380, Peiβenberg, Germany2024-07-16 變更
68超聲潔牙機(jī)工作尖國(guó)械備20210338號(hào)E.M.S.   Electro Medical Systems S.A.Rte.   de Champ-Colin 2, 1260 Nyon, Switzerland2024-07-16 變更
69吸唾管國(guó)械備20240072號(hào)E.M.S.   Electro Medical Systems S.A.Rte.   de Champ-Colin 2, 1260 Nyon, Switzerland2024-07-16 變更
70菌斑指示劑國(guó)械備20190173號(hào)Produits   Dentaires SA18   rue des Bosquets CH-1800 Vevey2024-07-15 無(wú)效
71創(chuàng)口貼國(guó)械備20240234號(hào)Young   Chemical Co., Ltd.80-93,   Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, 50969, Republic of   Korea2024-07-15 有效
72施夾鉗(不帶夾)國(guó)械備20200365號(hào)PETERS   SURGICAL 見(jiàn)附件22024-07-12 變更
73采血筆國(guó)械備20140036號(hào)華廣生技股份有限公司大慶廠臺(tái)中市南區(qū)大慶街二段100號(hào)2024-07-12 變更
74彈性繃帶國(guó)械備20171074號(hào)CIZETA   MEDICALI S.P.A.Via   IV Novembre,46-20012 CUGGIONO(MI)-ITALY2024-07-11 變更
75放射治療定位裝置國(guó)械備20240233號(hào)Anatomical   Geometry, S.L.C/   FORMACIóN, No 6 (NAVE), PARQUE INDUSTRIAL Y DE SERVICIOS ALJARAFE, 41927   MAIRENA DEL ALJARAFE - SEVILLA (ESPA?A)2024-07-11 有效
76移動(dòng)滑墊國(guó)械備20240232號(hào)ArjoHuntleigh   ABul.ks.Wawrzyniaka   2, 62-052 Komorniki, Poland2024-07-11 有效
77醫(yī)用檢查手套國(guó)械備20230074號(hào)GLOMAXES   LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan   4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul   Ehsan,Malaysia.2024-07-11 變更
78一次性醫(yī)用丁腈橡膠手套國(guó)械備20230069號(hào)GLOMAXES   LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan   4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul   Ehsan,Malaysia.2024-07-11 變更

由于文章篇幅限制，本文并未列出全部113個(gè)進(jìn)口第一類醫(yī)療器械備案產(chǎn)品，如有進(jìn)口第一類醫(yī)療器械產(chǎn)品備案代辦服務(wù)需求，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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