医疗器械产品CE认证申请单.docVIP

医疗器械产品CE认证申请单 CE-Marking Quotation Request Form for Medical Devices Manufacturer’s name: 生产商名称 Date: Address: （公司地址） Contact person: （联系人） Contact person`s telephone/e-mail: （联系电话/传真） Number of employees: （员工人数） Main site:（主要生产地）……………………………………. Additional site:（第一生产地）…………………………….. Additional……………………………………………………………………………………………. Subcontractor’s quality system/certificate:………………………………………..………………… 主要分供方的Sites:（附加公司场所） 其他主要分供方名称及地址 Please list any Subcontractors used for critical processes e.g. sterilization or main part of production : …………………………………………………………………………………………………………. ……………质量体系/证书 Quality System information /request for services: We have the following Quality system: （我司已具备以下管理体系） ISO 9001 Exp. Date______ ISO 13485 Exp. Date______ Certified by: （认证公司） DNV CMD Other Name of other: ______________Pls. enclose copy. （请注明其他认证机构名称并附证书） We would like to apply for the following: （我司现申请以下认证，请在右栏选择） CMD：ISO 9001:2000 ISO 13485:2003 DNV：ISO 9001:2000 ISO 13485:2003 产品CE认证 Define scope 认证范围 : Conformity assessment procedure by DNV as Notified Body （认证程序，该栏由DNV填写） Class Procedure Please indicate preference: Is Annex V + Annex VII Im Annex V + Annex VII IIa Annex V+ Annex VII IIa Annex II ÷ section 4 IIb Annex II ÷ section 4 III Annex II Class I device with a “m” Measuring function or placed on the market in a “s” Sterile Condition Note: Please list medical devices to be CE-marked on page 2 Please tick the box if the Medical Device incorporates: （该产品是否与以下设备连接） Medicinal Substances Yes No Animal Tissues Yes No HSA or Blood Derivates Yes No Radio and Telecommunication equipment Yes No Own Brand Labelling Yes No List of Medical devices to be CE marked （需申请CE认证的产品名称）Specify and please copy this page if more space is needed （如空间不够，请企业复印该页） Medical Device Generic Group incl. Software Short description of the device and indented medical use 医疗器械种类，包括软件 （请简单描述该产品及预期用途） Model/variants to be CE marked 型号 Medical Device 分类 Class Rule Steri