Declaration Of Conformity; Annex I + Annex Ii +Annex - LVI MagniLink Vision PREMIUM Manuel D'utilisation

DECLARATION OF CONFORMITY

Manufacturers name:
Manufacturers Address:
Web:
SRN (Single Registration Number):
Basic UDI-DI (GMN):
Brand name or trademark:
Product code:
Classification:
Type of equipment:
Conformity assessment route:
This declaration of conformity is issued under the sole responsibility of LVI Low Vision International AB. We
hereby declare that he medical device(s) specified above meet the provision of the Regulation (EU) MDR
2017/745 for medical devices. This declaration is supported by the Quality System approval to ISO 9001
issued by Intertek. All supporting documentation is retained at the premises of the manufacturer.
Manufacturer
Date
20-05-2021
Manuel d'utilisation 79 44 280c | MagniLink Vision PREMIUM
LVI Low Vision International AB
Verkstadsgatan 5
S-352 46 Växjö
Sweden
http://www.lviglobal.se
SE-MF-000004178
7330724MLVEJ
MagniLink
MLV
Class 1
Reading Aid
LVI Low Vision International AB uses the following
procedures for the CE-labeling of their products
according to the Regulation MDR 2017/745:
Class [1]: EC conformity declaration according to
Annex I + Annex II +Annex VII
Manufacturer's authorized representative
Signature
Clarification
Henrik Blomdahl
Position
Managing Director
24