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) Masker, tinnitus (KLW) (8)

Premarket Exempt

Yes

Clear

HANSATON - 07613389251210 Catalog Number : 050-6000-U969

Device Description : Dia 2 - Basic (Brown)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389251227 Catalog Number : 050-6001-U369

Device Description : Dia 2 - Enhanced Clarity (Beige)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389251234 Catalog Number : 050-6001-U469

Device Description : Dia 2 - Enhanced Clarity (Silver)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389251241 Catalog Number : 050-6001-U569

Device Description : Dia 2 - Enhanced Clarity (Grey)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389251258 Catalog Number : 050-6001-U669

Device Description : Dia 2 - Enhanced Clarity (Black)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389251265 Catalog Number : 050-6001-U769

Device Description : Dia 2 - Enhanced Clarity (White)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389251272 Catalog Number : 050-6001-U869

Device Description : Dia 2 - Enhanced Clarity (Bronze)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389251289 Catalog Number : 050-6001-U969

Device Description : Dia 2 - Enhanced Clarity (Brown)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

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