Unitron Hearing Ltd

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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 (ESD) (10)

Premarket Exempt

Yes

Clear

Unitron - 00698764246422 Catalog Number : 063-5284-01

Device Description : Next E CIC Omni Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764287586 Catalog Number : 063-5321-01

Device Description : Yuu CIC Power Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764287593 Catalog Number : 063-5322-01

Device Description : Yuu Full Shell Power Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294379 Catalog Number : 063-5395-01

Device Description : Passport CIC

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294386 Catalog Number : 063-5396-01

Device Description : Passport CIC Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294393 Catalog Number : 063-5397-01

Device Description : Passport Mini Canal

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294409 Catalog Number : 063-5398-01

Device Description : Passport Mini Canal Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294812 Catalog Number : 063-5399-01

Device Description : Passport Canal

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294829 Catalog Number : 063-5400-01

Device Description : Passport Canal Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764294836 Catalog Number : 063-5401-01

Device Description : Passport Canal Omni Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

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