declarationofconformity符合性声明mdd原件讲课稿.docxVIP

D ecla rati on - o f - C onfo rmit y - 符合性声明-- 2010 - MDD 原 件 MANUFACTURER: MEDICAL DEVICE:  NAME AND ADDRESS NAME, TYPE AND / OR MODEL OR SEE ATTACHED LIST - INCLUDE UMDNS AND/OR GMDN [NAME AND CODE] CLASSIFICATION - ANNEX IX: E.G. CLASS IIA, RULE 11 CONFORMITY ASSESSMENT ROUTE: E.G. ANNEX VII + V.3 WE, THE MANUFACTURER, HEREWITH DECLARE THAT THE STATED MEDICAL DEVICES MEET THE TRANSPOSITION INTO NATIONAL LAW, THE PROVISIONS OF COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES; INCLUDING, AT 21 MARCH 2010, THE AMENDMENTS BY COUNCIL DIRECTIVE 2007/47/EEC. ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURER. STANDARDS APPLIED: EN ISO 13485:2003/AC 2007, EN ISO 14971:2007, EN ISO 11135-1:2007, EN ISO 11607-1, EN ISO 11607-2, EN ISO 10993-1:2003, EN 556-1, EN1041:2008, EN 980:2008 以及适用的产品协调 标准，至于有哪些标准，具体察看协调标准网站 NOTIFIED BODY: TüV SüD PRODUCT SERVICE GMBH RIDLERSTR 65, D-80339 MüNCHEN, GERMANY IDENTIFICATION NUMBER (EC) CERTIFICATE(S): EUROPEAN REPRESENTATIVE: 0123 EC CERTIFICATE(S) NUMBER(S) SHOW ONLY THE EC CERTS WITH A SCOPE THAT COVERS THE PRODUCTS LISTED Shanghai International Trading Corp. GmbH (Europe) Eiffestrasse, 80, D-20537, Hamburg, Germany Tel: 0086-021-0049-40-2513175，Fax: 0049-40-255726 START OF CE-MARKING: DATE OF FIRST CE MARKING (OR LOT OR SERIAL NUMBER) USUALLY = ISSUE DATE OF EC CERT. (AND ADD END DATE - WHEN EC CERT. VALIDITY ENDS, OR WHEN DEVICE CEASES TO BE MARKETED, OR WHEN NB IS CHANGED) PLACE, DATE OF DECLARATION: SIGNATURE: CITY, DATE NAME: POSITION: (RESPONSIBLE SENIOR EXECUTIVE OF MANUFACTURER)