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Guangzhou King Yon Medical Tech Co., Ltd

8888 信任点

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

查看电话号码

sales@king-yon.com

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1st 年

Surgical Suit with 510K And TUV CE

China

According to Customer Specification

( Negotiable ) Get Latest Price

China

-

50000 Piece

as per attach photo or brochure

2-3 weeks

100000 Piece per Week

T/T

surgical suit

今すぐお問い合わせください

製品仕様

Reinforced : Breathable Comfortable : Ergonomic fit

タイトルまたは説明

Product NameSterile 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

*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
 
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
Surgical Suit with 510K And TUV CE Surgical Suit with 510K And TUV CE Surgical Suit with 510K And TUV CE Surgical Suit with 510K And TUV CE Surgical Suit with 510K And TUV CE

お問い合わせ

連絡先担当者:Mr. Sam

会社:Guangzhou King Yon Medical Tech Co., Ltd

住所: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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