User Guide 79 45 816a | MagniLink Vision Split
23
DECLARATION OF CONFORMITY
Manufacturers name:
LVI Low Vision International AB
Manufacturers Address:
Verkstadsgatan 5
S-352 46 Växjö
Sweden
Web:
http://www.lviglobal.se
SRN (Single Registration Number):
SE-MF-000004178
Basic UDI-DI (GMN):
7330724MLVEJ
Brand name or trademark:
MagniLink
Product code:
MLV-A100, MLV-A109, MLV-A111
Classification:
Class 1
Type of equipment:
Reading Aid
Conformity assessment route:
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
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
Manufacturer's authorized representative
Date
Signature
Position
20-05-2021
Managing Director
Clarification
Henrik Blomdahl
