Surgical Suit FDA 510K & TUV CE Level 3/4 of Guangzhou King Yon Medical Tech Co ., Ltd

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Certificate:
CE Certificate by TUV No: G2S 073966 0008 Rev. 01
Surgical Gown FDA Registration Record
Test Report Based on EN 13795-1:2019
TUV Level 4 Test Report Based on AAMI PB70:2012
TUV Level 3 Test Report Based on AAMI PB70:2012
TUV Level 2 Test Report Based on AAMI PB70:2012 

UMDNS Code:11901
Classification (MDD Annex IX): I Sterile, Rule 1
Conformity Assessment Route:Annex V section 3 

*Ergonomic fit, enables freedom of movement
*Reinforced
*Breathable and comfortable, suitable for most procedures
*Specially treated to repel low-tension surface fluids
 
We herewith declare that the above mentioned products meet the transposition into national law, the provisions of the following EC Council directives and Standards. All supporting documentations are retained under the premises of the manufacturer.
 
General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC
Standard Applied:
 
EN ISO 15223-1:2016    EN1041:2008     EN ISO 13485:2016
EN ISO 14971:2012      EN 13795:2011
Notified Body:TUV SUD Products Service GmbH, Ridlestr. 65, 80339, Munchen, Germany
Identification Number:0123
(EC) Certificate(S):G2S 073966 0008 Rev.01
Expire Date of the Certificate:2024-05-26
Start of CE Marking:2010-11-26
Place,Date of Issue:Xuchang, 2019-10-15