Surgical Gown 510K Level 3 Level 4 Certified By Guangzhou King Yon Medical Tech Co., Ltd, Others1
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Surgical Gown 510K Level 3 Level 4 Certified

Surgical Gown 510K Level 3 Level 4 Certified

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Minimum Order

Localité:

-

Prix de commande minimale:

-

Commande minimale:

50000 Piece

Packaging Detail:

as per attach photo or brochure

Delivery Time:

As per cutomer requirements

Supplying Ability:

300000 Piece per Day

Payment Type:

T/T

Contacter maintenant
Membre gratuit

Personne à contacter Mr. Sam

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

Contacter maintenant

Description

Product Name: Sterile Surgical Suit
Model No:According to Customer Specification
 
Certificate:
Surgical Gown
Test Report Based on EN 13795-1:2019
TUV Level 2 Test Report Based on AAMI PB70:2012
TUV Level 3 Test Report Based on AAMI PB70:2012
TUV Level 4 Test Report from TUV, 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

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

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

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