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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

查看电话号码

sales@king-yon.com

免费会员

Surgical Suit 510K Level 3/4 with CE

Others1

11901

( Negotiable ) 获取最新报价

Others1

-

50000 Piece

as per attach photo or brochure

As per cutomer requirements

300000 Piece per Day

T/T

surgical suit

现在联系

产品规格

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

详情

Product Name: Sterile Surgical Gown
Model No:According to Customer Specification
 
Certificate:

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
 

联系我们

联系人:Mr. Sam

公司名称:Guangzhou King Yon Medical Tech Co., Ltd

办公地址:Room 302C, No.718, Blv San Yuan Li, Bai Yuan District,, Changping, Guangdong, Others1,510403

电话号码:

查看電話號碼

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