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

FOB Price

Get Latest Price

( Negotiable )

|

50000 Piece Minimum Order

Country:

Others1

Model No:

11901

FOB Price:

( Negotiable ) Get Latest Price

Place of Origin:

Others1

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

Product Group :

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Free Member

Contact Person Mr. Sam

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

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Product Specification

  • 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

Product Description

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
 

Country: Others1
Model No: 11901
FOB Price: ( Negotiable ) Get Latest Price
Place of Origin: Others1
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
Product Group : surgical suit

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

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