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) (10) Masker, tinnitus (KLW) (10)

Premarket Exempt

Yes

Clear

HANSATON - 07613389094565 Catalog Number : 050-5712-U969

Device Description : Dia II-Enhanced Clarity (Brown)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389094572 Catalog Number : 050-5741-U469

Device Description : Oro-Basic (Silver)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094589 Catalog Number : 050-5741-U569

Device Description : Oro-Basic (Grey)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094596 Catalog Number : 050-5741-U669

Device Description : Oro-Basic (Black)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094602 Catalog Number : 050-5741-U769

Device Description : Oro-Basic (White)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094619 Catalog Number : 050-5741-U869

Device Description : Oro-Basic (Bronze)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389094626 Catalog Number : 050-5741-U969

Device Description : Oro-Basic (Brown)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389094633 Catalog Number : 050-5742-U469

Device Description : Oro-Enhanced Clarity (Silver)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389094640 Catalog Number : 050-5742-U569

Device Description : Oro-Enhanced Clarity (Grey)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389094657 Catalog Number : 050-5742-U669

Device Description : Oro-Enhanced Clarity (Black)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

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