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Guangzhou King Yon Medical Tech Co., Ltd

Room 302C, No.718, Blv San Yuan Li, Bai Yuan District,,Changping,Guangdong,Others1

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Surgical Suit with 510K And TUV CE


According to Customer Specification

( Negotiable ) Obtener el precio más reciente



50000 Piece

as per attach photo or brochure

2-3 weeks

100000 Piece per Week


surgical suit

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Especificaciones del producto

Reinforced : Breathable Comfortable : Ergonomic fit

Descripción del producto

Product NameSterile Surgical Suit
Model No.:According to Customer Specification

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

*Ergonomic fit, enables freedom of movement
*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
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


Persona de contacto:Mr. Sam

Empresa:Guangzhou King Yon Medical Tech Co., Ltd

Dirección:Room 302C, No.718, Blv San Yuan Li, Bai Yuan District,, Changping, Guangdong, China,510403


Mr. Sam < Guangzhou King Yon Medical Tech Co., Ltd >
quiero saber:

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