CE技术文件2概要1.docVIP

Table of Contents No. Document name Page No. Page number 1 Introduction of Manufacturer 2 1 2 Introduction of Product 3-6 4 3 Instruction for User 7 1 4 Applicable Standards 8 1 5 Label and Language 11-16 6 6 EC Declaration of Conformity 17 1 7 Essential Requirement Checklist 18 1 8 Risk Analysis Report 19 1 9 Test Report 20 1 10 Production Flow Chart 21 1 11 Attachment List and Attachments 22 1 Introduction of Manufacturer Introduction of the Manufacturer Our?company?Risen?started?medical?product?business?in?2006,?professional?in?manufacture?medical?orthopedic?products?(knee?braces,?arm?slings?etc.)?and?medical?disposable?products?(First?Aid?Bags/Kits,?Nonwoven?deep-process?products?etc) Based?on?nice?services,?competitive?prices?and?good?quality,?our?products?have?won?good?popularity?in?overseas?markets.?Warmly?welcome?your?inquiries.? The log of our company 1.2 Basic information of the Manufacturer 公司名称：瑞信国际实业有限公司地址广东省东莞市万江区简沙洲创业工业路7号0769-2638?1276 传真：0769-2638?1279 邮件：risenmedical@126.com Company name: Risen?Intl?Industrial?Co., LtdAddress:No.7?Chuangye?Industrial?Rd,?Jianshazhou?Wanjiang?Dis,?Dongguan?City,?Guangdong?Province?China?Tel:?0769-2638?1276Fax: 0769-2638?1279Mail: risenmedical@126.com Introduction of Product 2.1Classification The products include three categories: Nonwoven pads and Nonwoven balls; 2) First aid kits (including Bandages, cotton swab, cotton, emergency blanket, alcohol wipe, scissors, tweezers, gloves Protector According to the Rule 1, (Rule 1: All other active devices are in Class I. - Devices intended in general for external patient support.) of EU medical devices directive MDD（Medical Devices Directive，93/42/EEC）lass I. The certification will be conducted against Annex VII of 93/42/EEC2.2 Product Description 2.2.1 Nonwoven pads and Nonwoven balls Name Nonwoven pads Nonwoven balls Size 5*5cm、7.5*7.5cm、10*10cm、10*20cm25*25cm、30*30cm、30*60cm The diameter of 2/3/5cm Constituent 70% viscose 30% polyest