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Guangzhou King Yon Medical Tech Co., Ltd

8888 نقاط الثقة

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

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sales@king-yon.com

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1st عام

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

China

11901

( Negotiable ) أحصل على آخر سعر

China

-

50000 Piece

as per attach photo or brochure

As per cutomer requirements

300000 Piece per Day

T/T

surgical suit

الاتصال الآن

مواصفات المنتج

AAMI PB70:2012 : EN 13795-1:2019 CE : TUV testing report for L2 L3 L4 Color : Blue EN ISO 15223-1:2016 : EN1041:2008 EN ISO 13485:2016 : EN ISO 14971:2012 EN 13795:2011 : TUV ISO 13485

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

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

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الشخص الذي يمكن الاتصال به:Mr. Sam

الشركة:Guangzhou King Yon Medical Tech Co., Ltd

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

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