编辑: Mckel0ve 2019-10-08
"备案信息导出" "序号","产品名称","备案号","备案人","备案单位","分类编码","结构特征","型号、规格","产品描述","预期用途","生产地址","备案日期","状态","备案办理人" "1","医用阴道冲洗器","赣饶械备20180019号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6866","无源","200ml、180ml、150ml、100ml、50ml、30ml","通常由冲洗头与贮液罐组成,采用聚乙烯等高分子材料制成.

","用于女性阴道、会阴的冲洗","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "2","医用冰袋","赣饶械备20180017号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6858","无源","RD-L、RD-M、RD-S","由冰袋和各种形式的外套、固定带、无纺布背衬层、凝胶层、聚乙烯薄膜覆盖层等组成.冰袋内装有冷敷凝胶或蓄冷剂.用于人体特定部位(如眼).","用于物理退热、冷敷理疗.仅用于闭合性软组织.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "3","止血带","赣饶械备20180018号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6864","无源","350*20*0.5mm、450*20*0.5mm","间接作用于创面,捆绑到病人某个部位,对其施加一定压力,以起到治疗或辅助性治疗目的的用品.","用于加压包扎,达到消除腔隙、临时止血(非动脉止血)、保护手术切口、预防疝气等辅助性治疗效果.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "4","电动移位机","赣饶械备20180013号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6856","无源","手动移位机、电动移位机1070mm*630mm*1200mm、","可由液压、机械等装置组成,也可为板、垫状.","用于危重病人的位置移动,以减少病人在转移过程中受到伤害,包括过床移动等.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "5","刮痧器","赣饶械备20180014号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6827","无源","型号SRHWYL-头部、SRHWYL-眼部、SRHWYL-鼻部、SRHWYL-面颊部、SRHWYL-唇部、SRHWYL-耳部","通常采用天然水牛角、岫玉、砭石等材料加工磨光制成.","用于刮痧.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "6","疝气带","赣饶械备20180015号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6864","无源","成人腹股沟型儿童腹股沟型婴幼儿腹股沟型婴幼儿脐疝型","间接作用于创面,捆绑到病人某个部位,对其施加一定压力,以起到治疗或辅助性治疗目的的用品.","本产品适用于用于加压包扎,达到消除腔隙、临时止血(非动脉血),保护手术刀口,防止疝气等辅助治疗效果.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "7","鼻窦冲吸器","赣饶械备20180016号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6805","无源","1000ml、500ml、450ml、400ml、350ml、300ml、250ml、200ml、180ml、150ml、100ml、50ml、30ml","通常由吸引头、吸引管和接头组成.头部为弯头端呈圆形.可重复使用.本产品以非无功形成提供.","用于耳鼻喉手术中,与吸引装置配合,吸取废液或残渣组织或残渣组织或冲洗手术部位.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "8","医用固定带","赣饶械备20180011号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6810","无源","颈椎固定型、腰椎固定型、束腹带型、护腰带型、肚脐型","骨科创伤手术配套工具.通常由不锈钢材料制成,可重复使用","用于骨折外固定","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "9","病人推车","赣饶械备20180012号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6854","无源","型号:大小轮推车小四轮推车规格:1220*680*

760、1220*450*

460、2200*580*

870、2000*580*

870、1900*580*

870、1800*580*

870、1850*625*

500、1900*750*

450、1900*600*

800、1900*600*

800、2000*650*

720、2000*630*

600、2000*800*

650、2000*700*700","由床面(推车面板、担架面)、支撑架、护栏、脚轮(若可推移)等组成","用于运送转移患者.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "10","医用护理垫","赣饶械备20180010号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6864","无源","宽:20-240长:20-360","一次性使用病床或护理床上用的卫生护理用品.不包括手术室、产房内使用的各种手术垫、单.本产品由淋膜非织造布或非织造布、卫生纸(或木棉、绒毛浆)、塑料薄膜为主要原材料制成.","用于卧床病人保洁或预防褥疮","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇" "11","医用冷敷眼罩","赣饶械备20180009号","上饶市宏伟医疗器械有限公司","上饶市食品药品监督管理局","6858","无源","55mm*85mm?50mm*70mm?50mm*120mm80mm*115mm?70mm*100mm?70mm*90mm?90mm*115mm?100mm*120mm?80mm*100mm90mm*120mm?100mm*140mm?100mm*105mm?80mm*120mm?90mm*130mm?100mm*130mm?120mm*140mm?140mm*160mm130mm*160mm?140mm*160mm?160mm*180mm直径30mm直径60mm","由冰袋和各种形式的外套、固定带、无纺布背衬层、凝胶层、聚乙烯薄膜覆盖层等组成.冰袋内装有冷敷凝胶或蓄冷剂.用于人体特定部位(如眼).","用于物理退热、冷敷理疗.仅用于闭合性软组织.","江西省上饶市冰玉山县凤凰印象4幢12-13号","11-02-22","有效","廖贵勇"

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