EU Declaration of Conformity CE符合性声明 俄罗斯

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EU Declaration of Conformity CE符合性声明 俄罗斯

XXX Co. LTD
XXX China
 
 
EU Declaration of Conformity
Ref No: XXX
 
 
This EU declaration of conformity is issued under the sole responsibility of XXX Co. LTD, the manufacturer of the below listed CE marked medical devices. The requirements specified in EU Regulation 2017/745(MDR) regarding medical devices have been fulfilled in relation to the listed device groups.
 
The declared medical devices comply where appropriate, with the following European standards:
EN ISO 15223-1:2016, EN 1041:2008+A1:2013,
EN ISO 14971:2019, EN ISO 10993-1:2020,
EN ISO 10993-5:2009, EN ISO 10993-10:2013
 
Classification Rationale
ClassⅠby Rule 1 of Annex VIII of Regulation (EU) 2017/745/MDR.
Basic UDI-DI: N/A
CS Reference: N/A
 
Products
PU GEL INSOLES: A01, A02, A03, AXXX, W01, W02, W03, WXXX, R01, R02, R03, RXXX, H01, H02, H03, HXXX, M01, M02, M03, MXXX, F01, F02, F03, FXXX;
 
TPE GEL INSOLES: TM01, TM02, TM03, TMXXX, TH01, TH02, TH03, THXXX;
 
SILICONE INSOLES: SH001, SH002, SH003, SHXXX, SW001, SW002,
SW003, SWXXX, SM001, SM002, SM003, SMXXX;
 
FOAM INSOLES (PU/EVA Foam Insoles): EM01, EM02, EM03, EMXXX, PF01, PF02,PF03, PFXXX, HB01, HB02, HB03, HBXXX;
 
SEBS FOOT CARE PRODUCTS: S01, S02, S03, SXXX, SA01, SA02, SA03, SAXXX,
SM01, SM02, SM03, SMXXX
 
 
Place: XXX Co. LTD
XXX China
 
 
Name:  
Signature:                             Date:         June 02, 2021      
Position：Quality Manager