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www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500
18.0 CE Declaration of Conformity
Declaration of Conformity for:
The COVVI Power Supply
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning
Medical Devices.
The undersigned declares that the products described in this document meet the Council provisions that
apply to them and the CE Mark may be affixed.
Who is the natural and legal person with responsibility for
the design, manufacture, packaging and labelling before the
device is placed on the market under this manufacturer’s
name regardless of whether these operations are carried
out by the manufacturer or on his behalf by a third party.
General Product Name:
COVVI Power Supply
Legal Manufacturer:
(Name on Label)
COVVI Ltd., Unit 4 (Direct House), Quayside Business Park,
George Mann Road, Leeds, LS10 1DJ, United Kingdom
Manufacturers SRN:
N/A (Not Yet Available)
Basic UDI-DI:
506072613GMN004X2
GMDN Code
36534
Variants:
As per Appendix II (Available on Request) - Product Listing/Schedule
Intended Purpose:
The COVVI Hand is to be used exclusively for exoprosthetic
fittings of the upper limbs
MDR Classification:
Class 1 [Rule 13]
Notified Body:
N/A
EC Certificate:
N/A
EU Authorised Representative:
Advena Limited. Tower Business Centre, 2nd Floor.,
Tower Street, Swatar, BKR 4013, Malta
EU Authorised Representative SRN:
MT-AR-000000234
Medical Device Regulation
Assessment Route:
In conformity with Annexes II and III and have drawn up the DoC
in accordance with Article 19 of the Medical Device Regulation.
Simon Pollard, CEO
November 12th 2021
Summary of Contents for HAND
Page 2: ...Anything Is Possible...
