declaration-of-conformity-符合性聲明---mdd原件講課稿

1、Dec l a r at i on-of-Conform i ty-符合性聲明201 0-MDD原件nilManufacturer：name and addressMedical Device：name, type and/ or modelor See Attached List- include UMDNS and/or GMDN name and codeCLASSIFICATION - ANNEX IX：EG CLASS IIA, RULE 11EGCONFORMITYASSESSMENT ROUTE:F 右 ANNEX VI1 + V-3EGWE, THE MANUFACTURER,

2、 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

3、at the premises OF THE MANUFACTURER.Standards APPLIED： ENISO 13485:2O03/AC2O07, ENISO 14971:2007, ENISO 11135-1:2007, ENISO 11607-1, ENISO 11607-2, ENISO 10993-1:2003, EN556-1, EN1041:2008, EN980:2008 以及適用的產(chǎn)品協(xié)調(diào) 標(biāo)準(zhǔn)，至于有哪些標(biāo)準(zhǔn)，具體察戳調(diào)標(biāo)準(zhǔn)網(wǎng)站Notified body：TUv SUd Product service gmbhridlerstr 65, D-80339 Munch

4、en, GermanyIDENTIFICATION NUMBER 0123(EC) Certificate(s)：ec certificate(s) number(s)show only the EC certs with a scope that covers the products listedECREPeUROPEAN rEPRESENTATIVE :Shanghai International Trading Corp. GmbH (Europe)Eiffestrasse, 80, D-20537, Hamburg, Germany Tel: 0086-02165951371, 0049-40-2513175, Fax: 0049-40-255726Start 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：city