510K Level 3 Level 4 Sterile Surgical Suits

الوصف

Product Name: Sterile Surgical Suit

Model No.:According to Customer Specification

Certificate:
 510K No.: K192290
TUV CE Based on EN 13795-1:2019 (CE No.:  G2S 073966 0008 Rev. 01)
TUV Level 4 Test Report from TUV, 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
TUV ISO 13485

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:11901

Classification (MDD Annex IX): I Sterile, Rule 1

Conformity Assessment Route:Annex V section 3



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:TV SD 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


*Ergonomic fit, enables freedom of movement

*Reinforced

*Breathable and comfortable, suitable for most procedures

*Specially treated to repel low-tension surface fluids

 

Manufacturing Center:10

Sterilization Center: 2

Employee: 4000

RD Center:2

Market: 74 Countries