XLS《2018年11月》

"2018年11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","柳州","广西柳州圣美康医疗器械有限公司","一次性医用垫单","详见医疗器械注册证","桂械注准20182140072","柳州市柳江县新兴工业园新兴路8号","柳州市柳江县新兴工业园新兴路8号","――","43433","45258","――","首次注册" "2","南宁","南宁科伦新技术有限公司","多功能电离子手术治疗机(型号:GX-Ⅲ型)","GX-Ⅲ型","桂械注准20182010070","南宁市大岭路98号","南宁市大岭路98号","――","43432","45257","――","首次注册" "3","桂林","桂林恒保健康防护有限公司","聚氨酯避孕套","型号光面;

规格W49mm、W52mm、W55mm","桂械注准20182180074","桂林市桂林经济技术开发区水荆东路1-2号","桂林市桂林经济技术开发区水荆东路1-2号","――","43434","45259","――","首次注册" "4","桂林","桂林恒保健康防护有限公司","震动组合式避孕套","型号RC

011、RC

012、RC013;

规格W52mm","桂械注准20182180075","桂林市桂林经济技术开发区水荆东路1-2号","桂林市桂林经济技术开发区水荆东路1-2号","――","43434","45259","――","首次注册" "5","桂林","桂林恒保健康防护有限公司","复合型阻隔避孕套","光面W49mm、W52mm、W55mm","桂械注准20182180078","桂林市桂林经济技术开发区水荆东路1-2号","桂林市桂林经济技术开发区水荆东路1-2号","――","43434","45259","――","首次注册" "6","桂林","桂林恒保健康防护有限公司","天然乳胶橡胶避孕套","型号光面、非光面规格W46mm、W49mm、W50mm、W52mm、W53mm、W55mm、W58mm","桂械注准20182180076","桂林市桂林经济技术开发区水荆东路1-2号","桂林市桂林经济技术开发区水荆东路1-2号","――","43434","45259","――","首次注册" "7","桂林","桂林恒保健康防护有限公司","女用避孕套","光面W75mm","桂械注准20182180077","桂林市桂林经济技术开发区水荆东路1-2号","桂林市桂林经济技术开发区水荆东路1-2号","――","43434","45259","――","首次注册" "8","桂林","桂林优利特医疗电子有限公司","C-反应蛋白测定试剂盒(乳胶免疫比浊法)","URIT5C12","桂械注准20182400073","桂林市高新区信息产业园D-07号","桂林市高新区信息产业园D-07号","――","43433","45258","――","首次注册" "9","南宁","南宁天成义齿科技有限公司","定制式活动义齿","详见医疗器械注册证","桂械注准20182170071","南宁市国凯大道19号B1栋5楼501","南宁市国凯大道19号B1栋5楼501","――","43433","45258","――","延续" "10","柳州","广西柳州圣美康医疗器械有限公司","脱脂纱布块","详见医疗器械注册证","桂械注准20152640098","柳州市柳江县新兴工业园新兴路8号","柳州市柳江县新兴工业园新兴路8号","产品技术要求变更,规格型号、结构及组成","42318","44144","43411","许可事项变更" "11","桂林","桂林市威诺敦医疗器械有限公司","定向药透仪","规格型号:WND-ZZ-1TD、WND-ZZ-2TD","桂械注准20172260176","桂林市高新区金鸡路挂子山科技园区","桂林市高新区金鸡路挂子山科技园区","产品技术要求变更,规格型号、结构及组成、产品适用范围","43032","44857","43418","许可事项变更" "12","北海","北海瑞泰医疗器械有限公司(原:北海伟明医疗器械有限公司)","定制式固定义齿","①非贵金属为主体材料:金属铸造桥、金属铸造冠、贴面、嵌体、桩核;