DECLARATION OF CONFORMITY 符合性声明 菲律宾

  涉外文件格式样本     |      2021-11-03 11:45
DECLARATION OF CONFORMITY 符合性声明 菲律宾

XXX CO., LTD.
Add: XXX, China
Tel:+86-XXX  Fax:+86-XXX
 
 
DECLARATION OF CONFORMITY
 
We hereby declare that the below mentioned medical devices have been classified according to the classification rules and conform to the Essential Principles for Safety and Performance.
 
Name of Product Owner: XXX CO., LTD.
Address of Product Owner: XXX, China
Name of Physical Manufacturer: XXX CO., LTD.
Address of Physical Manufacturer: XXX China
Authorized Representative XXX CORPORATION
Address of Authorized
Representative		 XXX, Muntinlupa City
 
 
Medical Device(s): Medical Coverall Suit
Risk Classification: Class A
Product Serial Number: 03082020-1
Standards: ASTM F1671/F1671M-2013
Report No.: 21R000451
Verification Code: UGGT-4120-24
Issue Date: 2021-01-23
Quality Management System Certificate: Certificate No. XXX
Standards Applied: EN ISO 13485:2016
Certification/Notified Body: TUV SUD Product Service GmbH
 
 
I am aware that this Manufacturer’s Declaration is issued for the purpose of obtaining a product notification or product registration for Coverall. I am also aware of the penalties for making a false declaration and do confirm that the information given above are true and correct.
 
I herewith declare that the above mentioned products complied with standards required for the product. All supporting documentations are retained under the premises of the manufacturer. We are exclusively responsible for the declaration.
 
XXX CO., LTD.
 
XXX
Sales Manager
 
August 16, 2021