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 - 05706069293746 Catalog Number : 8 076 0100 025

Device Description : Widex mind440 M4-CIC/IIC (Light beige )

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293753 Catalog Number : 8 076 0100 027

Device Description : Widex mind440 M4-CIC/IIC (Dark brown )

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293760 Catalog Number : 8 076 0100 028

Device Description : Widex mind440 M4-CIC/IIC (Clay brown )

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293869 Catalog Number : 8 076 0200 025

Device Description : Widex Mind440 M4-CIC (Light beige ) RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293876 Catalog Number : 8 076 0200 027

Device Description : Widex Mind440 M4-CIC (Dark brown ) RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293883 Catalog Number : 8 076 0200 028

Device Description : Widex Mind440 M4-CIC (Clay brown ) RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293982 Catalog Number : 8 076 0300 025

Device Description : Widex Mind440 M4-CIC/IIC (Light beige ) Transverse receiver

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069293999 Catalog Number : 8 076 0300 027

Device Description : Widex Mind440 M4-CIC/IIC (Dark brown ) Transverse receiver

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069294002 Catalog Number : 8 076 0300 028

Device Description : Widex Mind440 M4-CIC/IIC (Clay brown ) Transverse receiver

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069294712 Catalog Number : 8 085 0100 025

Device Description : Widex Mind440 M4-X ITE (Light beige ) Telecoil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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