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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 Wrist Kit
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 Directive
provisions that apply to them and the CE Mark may be affixed.
Simon Pollard, CEO
November 12th 2021
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 Wrist Kit
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:
506072613GMN003WY
GMDN Code
41086
Variants:
As per Appendix II (Available on Request) - Product Listing/Schedule
Intended Purpose:
To mechanically and electrically connect the patients hand endoprosthesis to
their socket, batteries system and electrodes (or other input devices).
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.
Содержание HAND
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