{"text_format":"3","workbook":"xls","n_sheets":2,"sheets":["181号公告 附件2","规格型号附页"],"not_rendered":{"external_links":1,"defined_names":1},"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"181号公告 附件2","index":0,"n_rows":7,"n_cols":10,"rows_kept":7,"merged":[[0,0,0,9],[1,0,1,9]],"flags":["formulas_cached_only"]}
["附件2"]
["总局批准上市的药械组合产品名单"]
["序号","产品名称","申请单位","产品属性\n\n界定时间","界定结论","注册证书编号","结构组成","规格型号","预期用途","有效期"]
[1,"\n\n胃镜胶(含盐酸利\n\n多卡因)\n\n","新余市博源生化医用\n\n品有限责任公司","2010.12.8","以医疗器械为主\n\n的药械组合产品"," 国食药监械(准)字2014\n\n 第3660292号 ","该产品由二甲基硅油、聚山梨酯80、盐酸\n\n利多卡因、甘油、尼泊金乙酯及蒸馏水制\n\n成。该产品用于润滑、去除泡沫，添加的\n\n盐酸利多卡因用于减轻使用胃镜时的疼痛\n\n感。","7ml/瓶","该产品配套用于胃镜的诊断检查。","2014.2.7-2018.2.6"]
[2,"紫杉醇释放冠脉球\n\n囊导管","贝朗医疗（上海）国\n\n际贸易有限公司","2010.11.10","以医疗器械为主\n\n的药械组合产品"," 国食药监械(进)字2013\n\n 第3775397号","该产品为RX型球囊扩张导管，由球囊和导管\n\n等组件组成。球囊由尼龙弹性体/线形低密\n\n度聚乙烯制成，表面涂有药物涂层，涂层中\n\n所含药物为紫杉醇，剂量密度3μg/mm2，载\n\n体材料为优维显370,主要成分为碘普罗胺。\n\n环氧乙烷灭菌，一次性使用。","见附页","该产品用于冠状动脉支架内再狭窄的治疗。","2013.12.17-2017.12.16"]
[3,"抑菌涂层双面补片","戈尔工业品贸易（上\n\n海）有限公司","2013.9.5","以医疗器械为主\n\n的组合产品"," 国械注进20153461711 ","该产品由膨体聚四氟乙烯和抑菌涂层(碳酸\n\n银和醋酸氯己定)组成。环氧乙烷灭菌，仅\n\n限一次性使用。","见附页","该产品适用于疝和软组织缺损的重建，以及\n\n筋膜缺损的暂时性桥接。","2015.5.29-2020.5.28"]
[4,"抑菌涂层微孔补片","戈尔工业品贸易（上\n\n海）有限公司","2013.9.5","以医疗器械为主\n\n的组合产品"," 国械注进20153461767","该产品由膨体聚四氟乙烯和抑菌涂层(碳酸\n\n银和醋酸氯己定)组成，物理结构包含具有\n\n规则间隔的孔隙。环氧乙烷灭菌，仅限一次\n\n性使用。","见附页","该产品适用于疝和软组织缺损的重建，以及\n\n筋膜缺损的暂时性桥接。","2015.6.1-2020.5.31"]

{"sheet":"规格型号附页","index":1,"n_rows":44,"n_cols":4,"rows_kept":44,"merged":[[2,0,2,3],[13,0,13,3],[14,0,15,0],[14,1,15,1],[30,0,30,3],[31,0,32,0],[43,0,43,3]],"flags":["formulas_cached_only"]}
["附页"]
[]
["1.国食药监械（进）字2013第3775397号规格型号"]
["5022200,","5022201,","5022202,","5022204,"]
["5022205,","5022206,","5022207,","5022208,"]
["5022209,","5022210,","5022211,","5022212,"]
["5022213,","5022214,","5022215,","5022216,"]
["5022218,","5022219,","5022220,","5022221,"]
["5022222,","5022223,","5022224,","5022225,"]
["5022227,","5022230,","5022231,","5022232,"]
["5022233,","5022234,","5022235,","5022240,"]
["5022242,",5022243]
[]
["2.国械注进20153461711规格型号"]
["型号","标称厚度(mm)","标称宽度","标称长度"]
[null,null,"(cm)","(cm)"]
["1DLMCP02",1,8,12]
["1DLMCP03",1,10,"15*"]
["1DLMCP04",1,15,"19*"]
["1DLMCP05",1,7.5,10]
["1DLMCP06",1,18,24]
["1DLMCP07",1,20,30]
["1DLMCP08",1,26,"34*"]
["1DLMCP200",2,10,"15*"]
["1DLMCP201",2,15,"19*"]
["1DLMCP202",2,18,24]
["1DLMCP203",2,20,30]
["1DLMCP204",2,26,"34*"]
["* 椭圆形结构"]
[]
["3.国械注进20153461767规格型号"]
["型号","标称厚度","标称宽度","标称长度"]
[null,"(mm)","(cm)","(cm)"]
["1MYMP01",1,5,10]
["1MYMP02",1,5,15]
["1MYMP06",1,2.5,10]
["1MYMP07*",1,10,15]
["1MYMP08**",1,5,10]
["1MYMP09**",1,6,12]
["1MYMP10*",1,15,19]
["1MYMP15",1,18,24]
["1MYMP16",1,20,30]
["1MYMP18",1,7.5,12]
["*椭圆形结构  **孔型结构"]