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Sterile Surgical Suit TUV and 510K AAMI L4/3/2 EN13795

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Commande minimale:

50000 Piece

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as per attach photo or brochure

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As per cutomer requirements

Supplying Ability:

300000 Piece per Day

Payment Type:

T/T

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Guangzhou King Yon Medical Tech Co., Ltd

Others1

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Personne Ã contacter Mr. Sam

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

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Description

Product Name: Sterile Surgical Suit
Model No.:According to Customer Specification

Certificate:
FDA 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
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

Sterile Surgical Suit TUV and 510K AAMI L4/3/2 EN13795

Guangzhou King Yon Medical Tech Co., Ltd

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Sterile Surgical Suit TUV and 510K AAMI L4/3/2 EN13795

Guangzhou King Yon Medical Tech Co., Ltd

Description

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