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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

عرض رقم الهاتف

sales@king-yon.com

عضو مجاني

CE Sterile Surgical Gowns

بلد:

China

نموذج رقم:

11901

سعر فوب:

( Negotiable ) (قابل للتفاوض) أحصل على آخر سعر

الموقع:

China

سعر الحد الأدنى للطلب:

الحد الأدني للطلب:

50000 Piece

تفاصيل التغليف:

as per attach photo or brochure

موعد التسليم:

As per cutomer requirements

القدرة على التوريد:

300000 Piece per Day

نوع الدفع:

T/T

مجموعة المنتج :

surgical suit

الاتصال الآن

مواصفات المنتج

AAMI PB70:2012 : EN 13795-1:2019 CE : TUV testing report for L2 L3 L4 510K NO.: 192290 : Sterile EN ISO 15223-1:2016 : EN1041:2008 EN ISO 13485:2016 : EN ISO 14971:2012 EN 13795:2011 : TUV ISO 13485

الوصف

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