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 - 05714880151923 Catalog Number : 21010372

Device Description : WIDEX MAGNIFY MBR3D M10 (Mediterranean)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151930 Catalog Number : 21010374

Device Description : WIDEX MAGNIFY MBR3D M10 (Chestnut Brown)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151947 Catalog Number : 21010375

Device Description : WIDEX MAGNIFY MBR3D M10 (Dark Cherry)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151954 Catalog Number : 21010376

Device Description : WIDEX MAGNIFY MBR3D M10 (Tech Black)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151961 Catalog Number : 21010383

Device Description : WIDEX MAGNIFY MBR3D M10 (Silver Grey)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151978 Catalog Number : 21010377

Device Description : WIDEX MAGNIFY MBR3D M10 (Golden Brown)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151985 Catalog Number : 21010378

Device Description : WIDEX MAGNIFY MBR3D M10 (Titanium Grey)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880151992 Catalog Number : 21010379

Device Description : WIDEX MAGNIFY MBR3D M10 (Autumn Beige)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880152005 Catalog Number : 21010380

Device Description : WIDEX MAGNIFY MBR3D M10 (Deep Blue)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Widex - 05714880152012 Catalog Number : 21010381

Device Description : WIDEX MAGNIFY MBR3D M10 Demo (Silver Grey)

Device Class : 2

Duns Number: 309843613

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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