يبدو أنك لست عضوًا في TradeKey.com بعد. اشترك الآن للتواصل مع أكثر من 7 مليون مستورد ومصدر عالميًا.
انضم الآن ، مجانًا |
BOOK A CALL
Book Call On Your Favorite Time

By Signing Up. I agree to TradeKey.com Terms of Use, Privacy Policy, IPR and receive emails related to our services

Contact Us
Surgical Suit 510K Level 3/4 with CE

Surgical Suit 510K Level 3/4 with CE

|

Minimum Order

Place of Origin:

-

Price for Minimum Order:

-

Minimum Order Quantity:

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

الاتصال الآن
عضو مجاني

الشخص الذي يمكن الاتصال به Mr. Sam

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

الاتصال الآن

Description

Product Name: Sterile Surgical Gown
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      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
 

Send a direct inquiry to this supplier

إلى:

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

أريد أن أعرف: