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) (8) Hearing Aid, Air Conduction (ESD) (2)

Premarket Exempt

No Yes

Clear

Widex - 05706069294729 Catalog Number : 8 085 0100 027

Device Description : Widex Mind440 M4-X ITE (Dark brown ) Telecoil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069294736 Catalog Number : 8 085 0100 028

Device Description : Widex Mind440 M4-X ITE (Clay brown ) Telecoil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069295917 Catalog Number : 8 076 0400 025

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

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069295924 Catalog Number : 8 076 0400 027

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

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069295931 Catalog Number : 8 076 0400 028

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

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069296068 Catalog Number : 8 085 0200 025

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

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069296075 Catalog Number : 8 085 0200 027

Device Description : Widex Mind440 M4-X ITE (Dark brown ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069296082 Catalog Number : 8 085 0200 028

Device Description : Widex Mind440 M4-X ITE (Clay brown ) Telecoil, RC coil

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05706069305036 Catalog Number : 8 038 0100 000

Device Description : RC4 version 1 (Classic grey )

Device Class : 1

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Widex - 05706069305043 Catalog Number : 8 038 0100 068

Device Description : RC4 version 1 (Pearl white )

Device Class : 1

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

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