Bernafon AG

Address:Morgenstrasse 131,Bern,CH

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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) (9)

Premarket Exempt

No Yes

Clear

Bernafon - 05714464004928 Catalog Number :

Device Description : HEARLINK 2010 BTE PP, 2.4G NFM DPB BL DEMO

Device Class : 2

Duns Number: 480002286

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464006939 Catalog Number :

Device Description : BERNAFON ALPHA 9 MNR T R R SABE/MAC DEMO

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : OSM, KLW

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464006946 Catalog Number :

Device Description : BERNAFON ALPHA 7 MNR T R SABE/MAC DEMO

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : OSM, KLW

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464006953 Catalog Number :

Device Description : BERNAFON ALPHA 5 MNR T R SABE/MAC DEMO

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : OSM, KLW

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464006960 Catalog Number :

Device Description : AO9 MNR T R SABE/MAC DEMO ALIGO 9 GPL

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : KLW, OSM

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464006977 Catalog Number :

Device Description : AO7 MNR T R SABE/MAC DEMO ALIGO 7 GPL

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : OSM, KLW

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464006984 Catalog Number :

Device Description : AO5 MNR T R SABE/MAC DEMO ALIGO 5 GPL

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : OSM, KLW

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464008926 Catalog Number :

Device Description : BERNAFON ALPHA 9 MNR T R SABE/MAC

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : KLW, OSM

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464008933 Catalog Number :

Device Description : BERNAFON ALPHA 9 MNR T R SABE/MSIL

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : OSM, KLW

Prescription Use : Yes

Device Count : 1

Bernafon - 05714464008940 Catalog Number :

Device Description : BERNAFON ALPHA 9 MNR T R ANBR

Device Class : 2

Duns Number: 480002286

Premarket Exempt : No

Product Code : KLW, OSM

Prescription Use : Yes

Device Count : 1

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