XLS《2018年2月》

"2018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","桂林","桂林市啄木鸟医疗器械有限公司","超声洁牙机","UDS-N

6、UDS-N6LED、V

6、V6LED","桂械注准20182230018","桂林市国家高新区信息产业园","桂林市国家高新区信息产业园","――","02-14-22","02-13-27","――","首次" "2","南宁","广西威利方舟科技有限公司","一次性无创脑电传感器","Ark-1D","桂械注准20182210019","广西南宁国家高新区总部路3号中国东盟企业总部基地九号楼一楼","广西南宁国家高新区总部路3号中国东盟企业总部基地九号楼一楼","――","02-13-22","02-12-27","――","首次" "3","桂林","桂林懿可仕机械制造有限公司","超声洁牙机","SHEL-P","桂械注准20182230021","桂林市七星区朝阳路信息产业园D-8地块","桂林市七星区朝阳路信息产业园D-8地块1号楼A区","――","02-15-22","02-14-27","――","首次" "4","桂林","桂林懿可仕机械制造有限公司","内置式超声洁牙机","SHEL-BE,SHEL-BE.

LED","桂械注准20182230020","桂林市七星区朝阳路信息产业园D-8地块","桂林市七星区朝阳路信息产业园D-8地块1号楼A区","――","02-15-22","02-14-27","――","首次" "5","北海","北海银源医药科技有限公司","单体银妇用抗菌洗液","香型、色香型和普通型;

20ml/瓶、30ml/瓶、50ml/瓶、100ml/瓶、200ml/瓶","桂械注准20182640017","广西北海市西藏路9号","广西北海市西藏路9号","――","02-07-22","02-06-27","――","延续" "6","百色","平果精玉齿科配制服务部","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;

②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","桂械注准20182630016","平果县兴平路360号","平果县兴平路360号","――","02-07-22","02-06-27","――","延续" "7","桂林","桂林乐尔医疗器械有限公司","多参数分析仪","LBM-

01、LBM-01A、LBM-01T、LBM-01BU、LBM-01BA、LBM-01BT、LBM-01BAT","桂械注准20142400018","桂林市七星区漓江路18号","桂林市西城经济开发区鲁山工业园鲁山路13号","该产品变更如下:具体变更情况详见该公司医疗器械注册变更申请表.","11-21-18","11-20-23","02-14-22","许可事项变更" "8","桂林","桂林优利特医疗电子有限公司","全自动生化分析仪","URIT-8300/8301/8400/8401","桂械注准20162400021","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","该产品相关项目变更为:2.15参数:(1)样本盘:80个样本位,包含常规样本位、标准位、质控位、探针清洗位和急诊位;

各类样本可混合摆放,支持样本杯、新生儿超微量样本杯、原始采血管、塑料试管等.(14)最大同时在线分析项目(或处理项目):可同时测定项目81项(78项生化,3项电解质).","02-25-20","02-24-25","02-13-22","许可事项变更" "9","桂林","桂林优利特医疗电子有限公司","全自动生化分析仪","URIT-8360/8420/8421/8460","桂械注准20162400022","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","该产品变更如下: