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510K L3/4 TUV CE Sterile Surgical suits

Prix FOB

Obtenir le dernier prix

( Negotiable )

50000 Piece Minimum Order

Pays:

Others1

N Â° de modÃ¨le:

11901

Prix FOB:

( Negotiable )(Negotiable) Obtenir le dernier prix

LocalitÃ©:

Others1

Prix de commande minimale:

Commande minimale:

50000 Piece

Packaging Detail:

as per attach photo or brochure

Heure de livraison:

As per cutomer requirements

Capacité de Fournir:

300000 Piece per Day

Payment Type:

T/T

Groupe de produits :

surgical suit

Contacter maintenant

Guangzhou King Yon Medical Tech Co., Ltd

Others1

Membre gratuit

Personne Ã contacter Mr. Sam

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

Contacter maintenant

SpÃ©cification du produit

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

La description

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

Pays:	Others1
N Â° de modÃ¨le:	11901
Prix FOB:	( Negotiable ) (Negotiable) Obtenir le dernier prix
LocalitÃ©:	Others1
Prix de commande minimale:	-
Commande minimale:	50000 Piece
Packaging Detail:	as per attach photo or brochure
Heure de livraison:	As per cutomer requirements
Capacité de Fournir:	300000 Piece per Day
Payment Type:	T/T
Groupe de produits :	surgical suit