XLS《2019年2月》

"2019年2月第二类医疗器械产品注册信息表" "序号","地区","注册人名称","产品名称","规格型号","注册证号","注册人住所","生产地址","变更内容","批准日期","有效截止日期","变更日期","注册形式" "1","南宁","广西康柏莱科技有限公司","游离脂肪酸检测试剂盒(ACS/ACOD酶法)","R1:1*10mLR2:1*5mLR1:1*20mLR2:1*10mLR1:2*20mLR2:2*10mLR1:1*40mLR2:1*20mLR1:2*40mLR2:2*20mLR1:4*40mLR2:4*20mLR1:1*80mLR2:1*40mLR1:2*80mLR2:2*40mLR1:4*80mLR2:4*40mLR1:1*1000mLR2:1*500mLR1:2*1LR2:1*1L校准品:1*1.

0mL质控品:水平11*1.0mL质控品:水平21*1.0mL备注:校准品和或质控品,可与任何规格试剂组合包装.","桂械注准20192400004","南宁市国凯大道东19号金凯工业园南区9号厂房五层501号","南宁市国凯大道东19号金凯工业园南区9号厂房五层501号","/","43497","02-01-28","/","首次注册" "2","南宁","广西康柏莱科技有限公司","载脂蛋白A1检测试剂盒(免疫比浊法)","R1:1*15mLR2:1*5mLR1:1*30mLR2:1*10mLR1:2*30mLR2:2*10mLR1:1*60mLR2:1*20mLR1:2*60mLR2:2*20mLR1:4*60mLR2:4*20mLR1:1*90mLR2:1*30mLR1:2*90mLR2:2*30mLR1:4*90mLR2:4*30mLR1:3*500mLR2:1*500mLR1:3*1LR2:1*1LR1:1*6LR2:1*2L校准品:1*1.0mL质控品:水平11*1.0mL质控品:水平21*1.0mL备注:校准品和或质控品,可与任何规格试剂组合包装.","桂械注准20192400005","南宁市国凯大道东19号金凯工业园南区9号厂房五层501号","南宁市国凯大道东19号金凯工业园南区9号厂房五层501号","/","43497","02-01-28","/","首次注册" "3","南宁","巴迪泰(广西)生物科技有限公司","血清淀粉样蛋白A检测试剂盒(免疫荧光干式定量法)","25人份/盒、50人份/盒、100人份/盒、200人份/盒","桂械注准20192400006","南宁市江南区国凯大道东19号金凯工业园4号标准厂房1层、2层","南宁市江南区国凯大道东19号金凯工业园4号标准厂房1层、2层","/","43509","02-13-28","/","首次注册" "4","南宁","广西康柏莱科技有限公司","载脂蛋白B检测试剂盒(免疫比浊法)","R1:1*15mLR2:1*5mLR1:1*30mLR2:1*10mLR1:2*30mLR2:2*10mLR1:1*60mLR2:1*20mLR1:2*60mLR2:2*20mLR1:4*60mLR2:4*20mLR1:1*90mLR2:1*30mLR1:2*90mLR2:2*30mLR1:4*90mLR2:4*30mLR1:3*500mLR2:1*500mLR1:3*1LR2:1*1LR1:1*6LR2:1*2L校准品:1*1.0mL质控品:水平11*1.0mL质控品:水平21*1.0mL备注:校准品和或质控品,可与任何规格试剂组合包装.","桂械注准20192400007","南宁市国凯大道东19号金凯工业园南区9号厂房五层501号","南宁市国凯大道东19号金凯工业园南区9号厂房五层501号","/","43509","02-13-28","/","首次注册" "5","桂林","桂林世康医疗科技有限公司","超敏C反应蛋白测定试剂盒(散射比浊法)","50人份/盒、100人份/盒、200人份/盒、300人份/盒","桂械注准20192400008","桂林市七星区空明西路新建区五号小区(13-1号)创业大厦B座B507房","桂林市七星区空明西路新建区五号小区(13-1号)创业大厦B座B510房","/","43509","02-13-28","/","首次注册" "6","南宁","广西埃韦迪生物科技有限公司","荧光免疫分析仪","IVD-F1","桂械注准20192220009","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","/","43518","02-22-28","/","首次注册" "7","南宁","广西埃韦迪生物科技有限公司","胶体金免疫分析仪","IVD-CG10","桂械注准20192220010","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","/","43518","02-22-28","/","首次注册" "8","南宁","广西埃韦迪生物科技有限公司","胶体金免疫分析仪","IVD-CG24","桂械注准20192220011","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","/","43518","02-22-28","/","首次注册" "9","南宁","广西埃韦迪生物科技有限公司","荧光免疫分析仪","IVD-F24","桂械注准20192220012","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","/","43518","02-22-28","/","首次注册" "10","南宁","广西埃韦迪生物科技有限公司","胶体金免疫分析仪","IVD-CG1","桂械注准20192220013","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","南宁市洪历路2号宏象标准厂房工程3号装配车间

四、五层","/","43518","02-22-28","/","首次注册" "11","玉林","玉林市贵和医药有限公司","医用脱脂棉","规格:5g、10g、100g、250g、400g、500g型号:A型、B型","桂械注准20142140049","玉林市大北路858号","玉林市大北路858号","/","43511","02-15-28","/","延续注册" "12","玉林","玉林市贵和医药有限公司","医用脱脂纱布块","单层纱布的规格为8cm、10cm、12cm多层纱布的规格为5cm*7cm、65cm*8cm、8cm*10cm、10cm*10cm、95cm*19cm纱布卷(纱布绷带)的规格为4.8cm*500cm、6cm*500cm、8cm*500cm、4.8cm*600cm、6cm*600cm、8cm*600cm、12cm*20cm、30cm*30cm","桂械注准20142140051","玉林市大北路858号","玉林市大北路858号","/","43511","02-15-28","/","延续注册" "13","南宁","南宁钦玉义齿有限公司","定制式固定义齿","1.非贵金属为主体材料:金属铸造烤瓷桥、金属铸造烤瓷冠、贴面、嵌体、桩核.2.非贵金属为主体材料:金属铸造桥、金属铸造冠、贴面、嵌体、桩核.","桂械注准20142170032","南宁市金凯路20号科技楼二期4楼401房","南宁市金凯路20号科技楼二期4楼401房","/","02-28-23","02-27-28","/","延续注册" "14","南宁","南宁钦玉义齿有限公司","定制式活动义齿","铸造支架可摘局部义齿","桂械注准20142170033","南宁市金凯路20号科技楼二期4楼401房","南宁市金凯路20号科技楼二期4楼401房","/","02-28-23","02-27-28","/","延续注册"