Sonova AG

Address:28 LAUBISRUETISTRASSE,STAEFA Zurich,CH

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Filters

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

Hearing Aid, Air Conduction With Wireless Technology (OSM) (10)

Premarket Exempt

Yes

Clear

Unitron Brand - 07613389595000 Catalog Number :

Device Description : Relate3.1 Gold 312 Dir

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Relate3.1 Gold RIC 312 - 07613389600858 Catalog Number : 050-6403-P476

Device Description : Relate3.1 Gold RIC 312 (espresso)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Gold RIC 312 - 07613389600865 Catalog Number : 050-6403-P676

Device Description : Relate3.1 Gold RIC 312 (platinum)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Gold RIC 312 - 07613389600872 Catalog Number : 050-6403-R876

Device Description : Relate3.1 Gold RIC 312 (sand)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Silver RIC R - 07613389600889 Catalog Number : 050-6413-P476

Device Description : Relate3.1 Silver RIC R (espresso)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Silver RIC R - 07613389600896 Catalog Number : 050-6413-P676

Device Description : Relate3.1 Silver RIC R (platinum)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Silver RIC R - 07613389600902 Catalog Number : 050-6413-R876

Device Description : Relate3.1 Silver RIC R (sand)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Gold RIC R - 07613389600919 Catalog Number : 050-6415-P476

Device Description : Relate3.1 Gold RIC R (espresso)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Gold RIC R - 07613389600926 Catalog Number : 050-6415-P676

Device Description : Relate3.1 Gold RIC R (platinum)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Relate3.1 Silver BTE R - 07613389600933 Catalog Number : 050-6436-P476

Device Description : Relate3.1 Silver BTE R (espresso)

Device Class : 2

Duns Number: 480662550

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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