DOC 符合性声明 埃及

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DOC 符合性声明 埃及


 
XXX Co., Ltd.		 File name Declaration of conformity
File No. XXX
Version A3
 
XXX Co., Ltd.
XXX, PEOPLE’S REPUBLIC OF CHINA
 
MEDICAL DEVICE: Automatic Upper Arm Blood Pressure Monitor MODEL CODE: KF-65A, KF-65B, KF-65D, KF-65K CLASSIFICATION - ANNEX IX: Class IIa, rule10
CONFORMITY ASSESSMENT ROUTE:   ANNEX II, EXCLUDING SECTION  4
 
GMDN CODE: 16173 Sphygmomanometers, Electronic, Automatic
 
WE, XXX Co., Ltd. HEREWITH DECLARE THAT THE STATED MEDICAL DEVICES MEET THE PROVISIONS OF THE COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES, AS AMENDED BY COUNCIL DIRECTIVE 2007/47/EEC. THE MANUFACTURER IS EXCLUSIVELY RESPONSIBLE FOR THE DOC. ALL SUPPORTING DOCUMENTATIONS RETAINED UNDER THE PREMISES OF THE MANUFACTURER.
STANDARDS APPLIED: SEE ATTACHED LIST OF (HARMONISED - EN)  STANDARDS FOR WHICH DOCUMENTED EVIDENCE  OF COMPLIANCE CAN BE PROVIDED.
 
NOTIFIED BODY: TÜV SÜD Product Service GmbH Ridlerstraße 65
80339 MÜNCHEN
Germany
 
IDENTIFICATION NUMBER: 0123
 
(EC) CERTIFICATE(S): XXX
 
    SUNGO EUROPE B.V.
Olympisch Stadion 24, 1076 DE Amsterdam
START OF CE-MARKING: 2019.09.29
PLACE, DATE OF DECLARATION: Changsha CITY, DATE 2020.04.13


SIGNATURE:
NAME:XXX
POSITION: Management Representative
 

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XXX Co., Ltd.		 File name Declaration of conformity
File No. XXX
Version A3
Applied Standards List
 
No. Title of the
standard		 Reference of the standard Full or partial
compliance
 
1		  
MDD 93/42/EEC		 COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
medical devices		  
Full
 
2		 MEDDEV 2.7/1
rev.4		  
Clinical evaluation: Guide for manufactures and notified bodies		  
Full
 
3		 MEDDEV 2.12/1
rev.8		  
Guidelines on a Medical Devices Vigilance System		  
Full
 
4		 RoHS Directive 2011/65/EU
Annex II		  
On the restriction of the use of certain hazardous substances in electrical and electronic equipment		  
Full
 
5		  
EN ISO 15223-1:2016		 Medical devices. Symbols to be used with medical device Labels, labelling and information to be supplied - Part 1: General
requirements		  
Full
6 EN 1041: 2008 Information supplied by the manufacturer of medical devices Full
 
 		      






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