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2024年12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:2025-01-18 00:00瀏覽次數(shù):194次
近日，國(guó)家藥監(jiān)局披露《2024年12月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息》，2024年12月，國(guó)家局批準(zhǔn)待測(cè)物清洗液、CMV探針試劑（原位雜交法）、骨刮匙、顯微鑷、骨科手術(shù)器械、巴氏染色液、助行器等進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案167項(xiàng)，一起看正文。

近日，國(guó)家藥監(jiān)局披露《2024年12月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息》，2024年12月，國(guó)家局批準(zhǔn)待測(cè)物清洗液、CMV探針試劑（原位雜交法）、骨刮匙、顯微鑷、骨科手術(shù)器械、巴氏染色液、助行器等進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案167項(xiàng)，一起看正文。

進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案.jpg

2024年12月進(jìn)口第一類(lèi)醫(yī)療器械備案產(chǎn)品信息（部分產(chǎn)品）

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
待測(cè)物清洗液國(guó)械備20240447號(hào)Leica   Biosystems Newcastle LtdLeica   Biosystems Newcastle Ltd2024-12-31 
CMV探針試劑（原位雜交法）國(guó)械備20240446號(hào) Leica Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2024-12-31 
骨刮匙國(guó)械備20150444號(hào)Boss   Instruments, Ltd104   Sommerfield Drive,Gordonsville, VA229422024-12-31 
顯微鑷國(guó)械備20150508號(hào)Boss   Instruments, Ltd104   Sommerfield Drive Gordonsville,VA 229422024-12-31 
骨科手術(shù)器械國(guó)械備20240445號(hào)Dentavex   CorporationNear   John and Scot High School, Pir Hara Qabristan, Wazirabad Road Harar,   Sialkot,Pakistan2024-12-31 
核酸提取或純化試劑(Loopamp PURE DNA抽出キット)Loopamp PURE DNA Extraction Kit國(guó)械備20140018號(hào)栄研化學(xué)株式會(huì)社日本國(guó)栃木県大田原市下石上1381-3   1381-3 Shimoishigami,Otawara-shi,Tochigi, 324-0036 JAPAN 2024-12-31 
超聲探頭穿刺架國(guó)械備20200256號(hào)BK   Medical ApS401   Science Park Road State College PA 16803 USA2024-12-30 
巴氏染色液 Pap staining solution國(guó)械備20150386號(hào)/455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea2024-12-26 
抗酸染色液Acid fast staining solution(Fluorochrome)國(guó)械備20150400號(hào)/455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea2024-12-26 
革蘭染色液 Gram staining solution國(guó)械備20150365號(hào)/455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea2024-12-26 
抗酸染色液 Acid fast staining solution(Ziehl-Neelsen)國(guó)械備20150401號(hào)/455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea2024-12-26 
瑞氏-吉姆薩染色液 Wright-giemsa staining solution國(guó)械備20150385號(hào)/455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea2024-12-26 
染色機(jī) SMART AUTO  STAINER國(guó)械備20150335號(hào)Koreastandard   Co.,Ltd.455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea2024-12-26 
醫(yī)用嬰兒床國(guó)械備20190888號(hào)Hill-Rom,   Inc.County   Road 300 East Batesville, Indiana 47006 UNITED STATES2024-12-26 
基底帽國(guó)械備20240444號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-26 
種植體掃描體國(guó)械備20240443號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-26 
轉(zhuǎn)移體國(guó)械備20240442號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-26 
牙種植體手術(shù)器械包國(guó)械備20240441號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-26 
種植體螺絲起國(guó)械備20240440號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-26 
牙科種植器械限深套國(guó)械備20240439號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-25 
牙科種植用測(cè)量器國(guó)械備20240438號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-25 
骨科電鉆頭國(guó)械備20240437號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-25 
牙科種植用延長(zhǎng)器國(guó)械備20240436號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-25 
牙種植定位桿國(guó)械備20240435號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-24 
醫(yī)用橡膠手套國(guó)械備20171006號(hào)HARPS   INVESTMENT ASIA PTE.LTDLOT   10558, JALAN PERUSAHAAN 3,KAMUNTING INDUSTRIAL ESTATE 34600 KAMUNTING,   TAIPING, PERAK, MALAYSIA2024-12-24 
替代體國(guó)械備20240434號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-24 
牙科種植用連接件國(guó)械備20240433號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-24 
牙科種植用扳手國(guó)械備20240432號(hào)General   Implants GmbH DeutschlandEisenbahnstrasse   100, DE-78573 Wurmlingen2024-12-24 
手術(shù)輔助照明燈國(guó)械備20240431號(hào)DENTIS   CO., LTD.6,   Yuram-ro, Dong-gu, Daegu, Korea 2024-12-24 
心電導(dǎo)聯(lián)線(xiàn)國(guó)械備20240430號(hào)Philips   Medizin Systeme B?blingen GmbHGraf-Zeppelin-Straβe   21, 72202 Nagold, Germany2024-12-24 
鉆針深度停止器國(guó)械備20240429號(hào)Ossvis   Co., Ltd.B1,   38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of   Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic   of Korea2024-12-23 
替代體國(guó)械備20240428號(hào)Ossvis   Co., Ltd.B1,   38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of   Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic   of Korea2024-12-23 
手動(dòng)測(cè)量用器械國(guó)械備20240427號(hào)Ossvis   Co., Ltd.B1,   38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of   Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic   of Korea2024-12-23 
鞘液國(guó)械備20200675號(hào)Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2024-12-23 
鞘液國(guó)械備20200650號(hào)Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2024-12-23 
鞘液濃縮液國(guó)械備20200676號(hào)Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2024-12-23 
印模帽國(guó)械備20240426號(hào)Ossvis   Co., Ltd.B1,   38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of   Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic   of Korea2024-12-23 
種植體安裝輔助器械國(guó)械備20240425號(hào)Ossvis   Co., Ltd.B1,   38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of   Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic   of Korea2024-12-23 
免疫顯色試劑 ultraView SISH DNP Detection Kit國(guó)械備20150436號(hào)Roche   Diagnostics GmbH1910E.Innovation   Park Drive Tucson, AZ 85755 USA2024-12-20 
自動(dòng)加樣系統(tǒng)國(guó)械備20240424號(hào)Hamilton   Bonaduz AGVia   Crusch 8  7402 Bonaduz Switzerland2024-12-20 
放射治療患者用定位裝置國(guó)械備20240042號(hào)Qfix440   Church Road Avondale Pennsylvania 19311 USA2024-12-20 
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 Korea2024-12-19 
引流管國(guó)械備20200267號(hào)Zimmer   Surgical, Inc.200   Nw Parkway Rd Riverside, Mo 64150 USA2024-12-19 
牙科用毛刷國(guó)械備20240423號(hào)3M   ESPE Dental Products2510   Conway Avenue, St. Paul MN 55144, USA2024-12-19 
尿沉渣計(jì)數(shù)板國(guó)械備20240422號(hào)77   Elektronika Müszeripari Kft.Fehérvári   út 98. 1116 Budapest Hungary2024-12-18 
醫(yī)用干式膠片國(guó)械備20170780號(hào)富士フィルム株式會(huì)社靜岡県富士宮市大中里200番地2024-12-18 
上頜竇提升器國(guó)械備20180609號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科種植系統(tǒng)手術(shù)工具國(guó)械備20181529號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
手術(shù)刀柄國(guó)械備20180603號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
持針鉗國(guó)械備20170383號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科用鑷國(guó)械備20170459號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科用分離器國(guó)械備20170834號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
帕巾鉗國(guó)械備20230288號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科種植用扳手國(guó)械備20230287號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
口腔正畸用反光鏡國(guó)械備20230286號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科輸送器國(guó)械備20230284號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科修整用金剛砂車(chē)針國(guó)械備20200064號(hào)(?)????????   ??? ??? ???109?? 57, ????? ?? ??? 14, 613?2024-12-18 
牙齦刀國(guó)械備20180602號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
正畸鉗國(guó)械備20181528號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
橡皮障器械國(guó)械備20170154號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科用分離器國(guó)械備20160967號(hào)(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2024-12-18 
牙科去冠器國(guó)械備20230290號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科骨粉調(diào)和用金屬容器國(guó)械備20230289號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙探針國(guó)械備20170835號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
咬骨鉗國(guó)械備20170824號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
皮膚組織鉆孔器國(guó)械備20170854號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
止血鉗國(guó)械備20170370號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙骨錘國(guó)械備20170844號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科潔治器國(guó)械備20170823號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
口腔麻醉注射架國(guó)械備20170846號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科用剪國(guó)械備20160966號(hào)(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2024-12-18 
牙挺國(guó)械備20180608號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科開(kāi)口器國(guó)械備20170808號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
唇頰牽開(kāi)器國(guó)械備20170807號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙用尺國(guó)械備20170845號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
持骨鉗國(guó)械備20170853號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
口鏡國(guó)械備20170391號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙骨鑿國(guó)械備20170382號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
骨銼國(guó)械備20170847號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
牙科充填器國(guó)械備20170371號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
拔牙鉗國(guó)械備20170840號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 
組織拉鉤國(guó)械備20170839號(hào)(?)????????   ??? ??? ???109?? 572024-12-18 

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