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User Manual 7939408 | MagniLink Mira
DECLARATION OF CONFORMITY
according to the
Medical Devices Directive, 93/42/EEC with amendments from directive
2007/47/EC
Type of equipment:
Reading Aid
Brand name or trade mark:
MagniLink
Type designation:
MLMIRA-AD19
MLMIRA-AD23
Product class:
Class 1.
Manufacturer:
LVI Low Vision International AB
Address:
Verkstadsgatan 5
S-352 46 Växjö
Sweden
Web:
http://www.lvi.se
Phone:
Fax:
+46 470 - 72 77 00
+46 470 - 72 77 25
As the manufacturer, we declare under our sole responsibility that:
Ø
the product follows the provisions of the Council Directive 93/42/EEC with
amendments from directive 2007/47/EC.
Ø
we will keep the technical documentation described in section 3 of Annex VII
available to the national authorities for a period ending at least five years after the
last product has been manufactured.
Ø
the device meets the Essential Requirements of Annex 1 which applies to it, taken
into account the intended purpose of the device.
Ø
to follow the requirements regarding products placed on the market as described
in section 4 of Annex VII.
Manufacturer
Manufacturer´s authorized representative
Date
Signature
Position
2010-04-21
Managing Director
Clarification
Erik Bondemark
