糖化血红蛋白检测试剂盒CE技术文档（全套）

IVDD Technical File General Information Page 1 of 2 根据/According to 欧盟指令 98/79/EC Council Directive 98/79/EC (体外诊断设备/IVDD)制造商制造商/Manufacturer:（名称及地址，联系人；电话，传真或电子邮件）(Name and address,contact person;telephone,fax or e-mail)深圳市雷诺华科技实业有限公司 中国广东省深圳市南山区高新技术产业园区科技南二路 W2-B 栋一层东 联系人：胡亚军先生 电话：+86 755 86368398 传真：+86 755 26525016 LABNOVATION TECHNOLOGIES,INC.1F,W2-B Building,Keji 2nd Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,PR China Contact Person:Mr.Hu Yajun Tel:+86 755 86368398 Fax:+86 755 26525016 设计场所设计场所/Design facility(ies):(名称及地址/Name and address)生产场所生产场所/Manufacturing facility(ies):(名称及地址/Name and address)深圳市雷诺华科技实业有限公司 中国广东省深圳市南山区高新技术产业园区科技南二路 W2-B 栋一层东 LABNOVATION TECHNOLOGIES,INC.1F,W2-B Building,Keji 2nd Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,PR China 深圳市雷诺华科技实业有限公司 中国广东省深圳市南山区高新技术产业园区科技南二路 W2-B 栋一层东 LABNOVATION TECHNOLOGIES,INC.1F,W2-B Building,Keji 2nd Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,PR China 产品类别产品类别/Product category:产品产品/Product:体外诊断设备/IVDD 糖化血红蛋白（HbA1c）检测试剂盒 Glycosylated Hemoglobin Test Reagents Kit 分类分类/Classification:IVDD,non-self-testing device and other than those covered by List A and List B in Directive 98/79/EC.产品总述产品总述/General Description For the quantitative determination of Hemoglobin A1c in human blood.。生产（销售）历史生产（销售）历史/Product(Sales)history:2011 年起/Since 2011 产品更改计划产品更改计划/Planned Variants:无/None 认可认可/Existing Approvals:无/None IVDD Technical File General Information Page 2 of 2 签署人声明/The undersigned declares:履行被认证通过的质量体系的职责和义务/to fulfill the obligations arising from the quality system as approved.保持被认证通过的质量体系的有效性和足够性/to maintain the approved quality system in such way that it remains adequate and effective.质量体系显著变更或计划显著变更时通知签约认证机构，TUV 莱茵技术监护（深圳）有限公司/to inform the contracted Notified Body,TUV RHEINLAND GROUP,of and plan for substantial changes to the quality system.建立并保持系统过程以获得设备生产后阶段的经验，并通过适当的方式进行必要的改进/to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action.在得知以下情况时立即通知主管当局/to notify the competent authorities of the following incidents immediately on learning of them:I.设备系统性失效，以及任何不充分的指导说明可能导致患者或使用者死亡，或导致其健康严重损害/any malfunction or deterioration in the characteristics and/or performance of a device,as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;II.任何与设备特性或性能相关的技术的或医疗的原因，导致如（I）中所述的情况，而由制造商召回产品/any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph(I)to systematic recall of devices of the same type by the manufacturer.日期日期/Date:2017.04.14 公司代表：公司代表：Name of company representative:胡亚军胡亚军/Hu Yajun V6.9a Labnovation Technologies,I EC Declaration of Conformity according to the Directive 98/79/EC(applicable to Others/General IVD Devices only)Manufacturer:Labnovation Technologies,Inc.1Flr.,W2-B Bldg.,Keji 2 Rd.South Hi-Tech Industrial Park Shenzhen 518057,Guangdong,China Product/s:Glycosylated Hemoglobin Test Reagents Kit(Detergent A,Detergent B,Hemoglobin Lyse Micro-Column,Pump Tube Cassette)Model:300 Tests Category:Others/General Conformity assessment route:Annex III,except point 6,of Directive(Module A)Applicable Standards:ISO13485:2003+AC:2009,ISO9001:2008 ISO14971:2007,EN375:2001,EN980:2008 EN13612:2002,EN13640:2002 We,the Manufacturer,herewith declare with sole responsibility that our product/s mentioned above meet/s the provisions of the Directive 98/79/EC of the European Parliament and of the Council on In-Vitro Diagnostic Medical Devices.We hereby explicitly appoint MedNet GmbH(Add:Borkstrasse 10.48163 Muenster.Germany)to act as our European Authorised Representative as defined in the aforementioned Directive.Signed on 13 /(Day)04 /(Month)of 2017.Place Shenzhen,China Represented by Signature(on behalf of the manufacturer)_ Full Name of authorized signatory:Wang Rongguang Position held in the company:General Manager Company Seal/Stamp:IVDD Technical File Applicable List of Standards Page 1 of 1 Applicable List of Standards ISO13485:2016 Medical devices-Quality management systems-Requirements for regulatory purposes ISO9001:2008 Quality management systems-Requirements ISO14971:2012 Medical devices-Application of risk management to medical devices EN928:1995 In vitro diagnostic systems-Guidance on the application of EN29001 and EN46001 and of EN29002 and EN46002 for in vitro diagnostic medical devices EN375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use EN980:2008 Graphics symbols EN13612:2002 Performance evaluation of in vitro diagnostic medical devices EN13640:2002 Stability testing of in vitro diagnostic reagents EN13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reage