idi ComfortFin IDI3000 Instrucciones De Uso página 10

INSTRUCTIONS FOR USE
4 Compliance with Medical Device Regulations:
This product is a non-invasive, Class I Medical Device and system is CE-marked
according to Annex VIII, Rule 1, of the Medical Device Regulations (REGULATION
(EU) 2017/745).
EC Authorized Representative:
Emergo Europe
Prinsessegracht 20
2514 AP The Hague, Netherlands
Manufacturing Information:
KYRA MEDICAL, INC.
100 OTIS ST, SUITE 1
NORTHBOROUGH, MA 01532 USA
888-611-KYRA (NORTH AMERICA)
508-936-3550 (INTERNATIONAL)
EU Importer:
Kyra Medical Europe Limited
69 Esker Woods Drive
Lucan Co Dublin
K78PX45
IRELAND
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IFU Document Number: 03-0123-REV-E