Surgical Suit with 510K And TUV CE

Description

Product NameSterile Surgical Suit
Model No.:According to Customer Specification
 
Certificate:
FDA **0K No.: K*****0
TUV CE Based on EN ******1:***9 (CE No.:  G2S *****6 ***8 Rev. *1)
TUV Level 4 Test Report from TUV, Based on AAMI PB*0:***2
TUV Level 3 Test Report Based on AAMI PB*0:***2
TUV Level 2 Test Report Based on AAMI PB*0:***2
TUV ISO ****5

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

General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE *3/*2/EEC
Standard Applied:
 
EN ISO ******1:***6    EN***1:***8     EN ISO ****5:***6
EN ISO ****1:***2      EN ****5:***1
Notified Body:TV SD Products Service GmbH, Ridlestr. *5, ****9, Munchen, Germany
Identification Number:***3
(EC) Certificate(S):G2S *****6 ***8 Rev.*1
Expire Date of the Certificate:*********6
Start of CE Marking:*********6
Place,Date of Issue:Xuchang, *********5