Declaración De La Conformidad De La Ce - COVVI NEXUS Manual Tecnico

19.0 Declaración de la Conformidad de la CE
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.
General Product Name:
Legal Manufacturer:
(Name on Label)
Manufacturers SRN:
Basic UDI-DI:
GMDN Code
Variants:
Intended Purpose:
MDR Classification:
Notified Body:
EC Certificate:
EU Authorised Representative:
EU Authorised Representative SRN:
Medical Device Regulation
Assessment Route:
Edward Varley, CEO
December 22nd 2020
www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ |
Covvi Ltd., Unit 4 (Direct House), Quayside Business Park,
George Mann Road, Leeds, LS10 1DJ, United Kingdom
506072613GMN003WY
As per Appendix II (Available on Request) - Product Listing/Schedule
To mechanically and electrically connect the patients hand endoprosthesis to
their socket, batteries system and electrodes (or other input devices).
Advena Limited. Tower Business Centre, 2nd Floor.,
Tower Street, Swatar, BKR 4013, Malta
In conformity with Annexes II and III and have drawn up the DoC
in accordance with Article 19 of the Medical Device Regulation.
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.
COVVI Wrist Kit
N/A (Not Yet Available)
41086
Class 1 [Rule 13]
N/A
N/A
MT-AR-000000234
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