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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)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
    

                    
    
			            
    國(guó)家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
    
			            
    發(fā)布日期:2023-08-03 20:12瀏覽次數(shù):1748次
    
                        
    2023年8月2日，國(guó)家藥監(jiān)局發(fā)布進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告，2023年7月，國(guó)家局累計(jì)批準(zhǔn)頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。
    
			            
    2023年8月2日，國(guó)家藥監(jiān)局發(fā)布進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告，2023年7月，國(guó)家局累計(jì)批準(zhǔn)頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。
    進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg
    國(guó)家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
    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頸椎固定器國(guó)械備20170267號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
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    6肩部固定器國(guó)械備20220071號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
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    13刀頭國(guó)械備20200736號(hào)ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu. Daegu, Republic of Korea2023-07-28 變更
    14脊柱微創(chuàng)手術(shù)工具包國(guó)械備20210050號(hào) ENDOVISION Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
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    17醫(yī)用檢查手套國(guó)械備20230253號(hào)Koon   Seng Sdn.Bhd.PTD   16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
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    27手術(shù)刀國(guó)械備20210443號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-07-25 變更
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    32牙用尺國(guó)械備20161414號(hào)MIS   Implants Technologies Ltd.Bar   Lev Industrial Park, 2015600 Israel2023-07-24 變更
    33種植安裝輔助工具包國(guó)械備20190883號(hào)MIS   Implants Technologies Ltd.P.O.   Box 7 Bar Lev Industrial Park, 2015600, Israel 2023-07-24 變更
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    36牽開(kāi)器國(guó)械備20230354號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
    37血紅蛋白檢測(cè)用裝載片國(guó)械備20190477號(hào)Fresenius   Kabi AGVon-Cancrin-Straβe   1, 63877 Sailauf ,  Deutschland2023-07-24 變更
    38頭戴式檢查燈國(guó)械備20230353號(hào)(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
    39醫(yī)用放大鏡國(guó)械備20230352號(hào)(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
    40正畸鉗國(guó)械備20180071號(hào)Ortho   Organizers, Inc.1.Ranger   H.Q. Road Cantt, Sialkot – Pakistan；2.3232 N. Rockwell Street, Chicago, IL,   60618, United States；3.Nasir Road, Sialkot-Pakistan2023-07-21 變更
    41醫(yī)用檢查手套國(guó)械備20170208號(hào)Henry   Schein Services GmbHLot   1365, Batu 17, Jalan Sungai Sembilang, Jeram, Kuala Selangor, Selangor Darul   Ehsan 45800 Malaysia2023-07-21 變更
    42正畸鉗國(guó)械備20160817號(hào)Ormco   Corporation1)   1332 South Lone Hill Avenue, Glendora, California,  91740, USA;
         
         2) Circuito Sur No.31, Parque Industrial Nelson, Mexicali, B.C. C.P. 21395,   Mexico
         
         3) Calle Industrial Del Acero No.18, parque Industrial EL Vigia Mexicali,   Baja California Mexico 21397    		2023-07-21 變更
    43股骨干手術(shù)工具國(guó)械備20230351號(hào)SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，F(xiàn)RANCE2023-07-21 有效
    44CD28檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20230350號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
    45骨測(cè)量器國(guó)械備20200173號(hào)Rebstock   Instruments GmbHIn   Weiher Weiher?cker 7 78589 D Dürbheim Germany2023-07-20 無(wú)效
    46骨測(cè)量器國(guó)械備20230349號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7 78589 Dürbheim, Germany2023-07-20 有效
    47CD28檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20230348號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
    48瑞氏染色液   ADVIA Autoslide Modified Wright Stain國(guó)械備20151834號(hào)Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008 USA2023-07-20 變更
    49緩沖液   ADVIA Autoslide Modified Wright Buffer國(guó)械備20151129號(hào)Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008, USA2023-07-20 變更
    50CD28檢測(cè)試劑（流式細(xì)胞儀法）國(guó)械備20230347號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
    51洗板機(jī)國(guó)械備20190496號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
    52洗板機(jī)國(guó)械備20190874號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
    53洗板機(jī)國(guó)械備20181472號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
    54骨關(guān)節(jié)手術(shù)器械國(guó)械備20170306號(hào)DePuy   Mitek325   Paramount Drive Raynham, MA 02767 USA2023-07-20 變更
    55干式激光成像儀國(guó)械備20230346號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Str.117,2700 Wiener Neustadt, Austria2023-07-20 有效
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    57電極導(dǎo)聯(lián)線國(guó)械備20220096號(hào)Natus   Neurology Incorporated3150   Pleasant View Road Middleton Wisconsin 53562 USA； IDA Business Park Gort Co.   Galway Ireland； 250 Okgucheondong-ro Siheung-si Gyeongi-do 15084 Republic of   Korea2023-07-20 變更
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    59口腔數(shù)字觀察儀國(guó)械備20200038號(hào)ModJaw   SAS354   Voie Magellan 73800 Sainte-Hélène-du-Lac France2023-07-20 變更
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    61橡皮障器械國(guó)械備20171011號(hào)Kentzler-Kaschner   Dental GmbHMühlgraben   36,73479 Ellwangen/Jagst,Germany2023-07-19 變更
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