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 - 07613389094664 Catalog Number : 050-5742-U769

Device Description : Oro-Enhanced Clarity (White)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094671 Catalog Number : 050-5742-U869

Device Description : Oro-Enhanced Clarity (Bronze)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094688 Catalog Number : 050-5742-U969

Device Description : Oro-Enhanced Clarity (Brown)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389094947 Catalog Number : 050-5713-U369

Device Description : Dia II-Enhanced Clarity 7 (Beige)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389094954 Catalog Number : 050-5743-U369

Device Description : Oro-Enhanced Clarity 7 (Beige)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389095081 Catalog Number : 050-5713-U469

Device Description : Dia II-Enhanced Clarity 7 (Silver)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389095104 Catalog Number : 050-5713-U669

Device Description : Dia II-Enhanced Clarity 7 (Black)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389095111 Catalog Number : 050-5713-U769

Device Description : Dia II-Enhanced Clarity 7 (White)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

HANSATON - 07613389095128 Catalog Number : 050-5713-U869

Device Description : Dia II-Enhanced Clarity 7 (Bronze)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

HANSATON - 07613389095135 Catalog Number : 050-5713-U969

Device Description : Dia II-Enhanced Clarity 7 (Brown)

Device Class : 2

Duns Number: 316040146

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

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