Hansaton Akustik GmbH

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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) (8) Hearing aid, air conduction (ESD) (2)

Premarket Exempt

Yes

Clear

Hansaton - 04250185538072 Catalog Number : 82530

Device Description : AQ Comfort 3G Slim (beige)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185538089 Catalog Number : 82531

Device Description : AQ Comfort 3G Slim (silver)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185538096 Catalog Number : 82532

Device Description : AQ Comfort 3G Slim (grey)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185538102 Catalog Number : 82533

Device Description : AQ Comfort 3G Slim (black)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185538119 Catalog Number : 82534

Device Description : AQ Comfort 3G Slim (pearl)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185538133 Catalog Number : 82536

Device Description : AQ Comfort 3G Slim (bronze)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185539208 Catalog Number : 83461

Device Description : AQ Business 3G, skin, MM, II, left, 120/55

Device Class : 1

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Hansaton - 04250185539215 Catalog Number : 83460

Device Description : AQ Business 3G, skin, MM, II, right, 120/55

Device Class : 1

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Hansaton - 04250185539222 Catalog Number : 83459

Device Description : AQ Business 3G, skin, MM, II, WL, left, 120/55

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Hansaton - 04250185539239 Catalog Number : 83458

Device Description : AQ Business 3G, skin, MM, II, WL, right, 120/55

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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