Unitron Hearing Ltd

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 - 00698764241410 Catalog Number : 063-5187-01

Device Description : Yuu CIC Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241427 Catalog Number : 063-5188-01

Device Description : Yuu Mini Canal Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241434 Catalog Number : 063-5189-01

Device Description : Yuu Canal Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241441 Catalog Number : 063-5190-01

Device Description : Yuu Half Shell Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241458 Catalog Number : 063-5191-01

Device Description : Yuu Full Shell Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241465 Catalog Number : 063-5192-01

Device Description : Yuu Canal Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241472 Catalog Number : 063-5193-01

Device Description : Yuu Half Shell Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241489 Catalog Number : 063-5194-01

Device Description : Yuu Full Shell Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764241496 Catalog Number : 063-5195-01

Device Description : Yuu Full Shell Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764245739 Catalog Number : 063-5241-01

Device Description : Next 16 Full Shell Omni Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

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