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
 
Manufacturing Center:*0
Sterilization Center: 2
Employee: ***0
RD Center:2
Market: *4 Countries
 
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.
 
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