Widex A/S

Address:Nymoellevej 6,Lynge Hovedstaden,DK

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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)

Premarket Exempt

No Yes

Clear

Widex - 05706069326895 Catalog Number : 8 201 0103 021

Device Description : Widex mind440 M4-9 BTE (Warm beige ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326901 Catalog Number : 8 201 0103 030

Device Description : Widex mind440 M4-9 BTE (Jet black ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326918 Catalog Number : 8 201 0103 071

Device Description : Widex mind440 M4-9 BTE (Cappuccino brown ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326925 Catalog Number : 8 201 0103 072

Device Description : Widex mind440 M4-9 BTE (Winter silver ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326932 Catalog Number : 8 201 0103 073

Device Description : Widex mind440 M4-9 BTE (Titan grey ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326949 Catalog Number : 8 201 0103 081

Device Description : Widex mind440 M4-9 BTE (Tan silk ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326956 Catalog Number : 8 201 0203 021

Device Description : Widex mind440 M4-9 BTE (Warm beige ) Telecoil, Volume control, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326963 Catalog Number : 8 201 0203 030

Device Description : Widex mind440 M4-9 BTE (Jet black ) Telecoil, Volume control, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326970 Catalog Number : 8 201 0203 071

Device Description : Widex mind440 M4-9 BTE (Cappuccino brown ) Telecoil, Volume control, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069326987 Catalog Number : 8 201 0203 072

Device Description : Widex mind440 M4-9 BTE (Winter silver ) Telecoil, Volume control, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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