医疗器械产品C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 Medicinal Substances: : by meaning of 65/65/EEC ? Medicinal Substances: : by meaning of 65/65/EEC Animal Tissues Animal Tissues: by meaning of 2003/32/EEC, clinical evaluation for justification of use to be included.