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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).
4.1 EC Authorized Representative:
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
4.3 UK Authorized Representative:
Emergo Consulting (UK) Limited
c/o Cr360 - UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
United Kingdom
4.5 CH Authorized Representative:
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
©2023 Kyra Medical, Inc.
4.2 Manufacturing Information:
Kyra Medical, Inc.
102 Otis St
Northborough, MA 01532 USA
888-611-KYRA (North America)
508-936-3550 (International)
4.4 EU Importer:
Kyra Medical Europe Limited
Office 2, 12A Lower Main St
Lucan Dublin
K78X5P8
Ireland
7
IFU 03-0396 REV H
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