KOALYS TECHNOLOGIES LTD

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Audiometer (EWO) (1)

Premarket Exempt

Yes

Clear

Audyx - 07290017820019 Catalog Number : N/A

Device Description : Audyx is an online audiology platform for patients care. It runs on a computing Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders

Device Class : 2

Duns Number: 600023242

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

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