Oticon Medical AB

Address:Datavagen 37B,Askim Vastra Gotaland,SE

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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, Bone Conduction (LXB) (5) Hearing Aid, Bone Conduction, Implanted (MAH) (5)

Premarket Exempt

Clear

Ponto - 05712149000562 Catalog Number : M50384

Device Description : Screwdriver, machine, 35mm

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149000586 Catalog Number : M50386

Device Description : Square fit connection, machine

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149000647 Catalog Number : M50428

Device Description : Sound processor indicator

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149000654 Catalog Number : M50437

Device Description : Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriv Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562).

Device Class :

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149000661 Catalog Number : M50446

Device Description : Telecoil

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Oticon Medical - 05712149000777 Catalog Number : M50504

Device Description : Genie Medical fitting software

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149001026 Catalog Number : M50534

Device Description : Screwdriver hexagon

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149001101 Catalog Number : M50551

Device Description : Soft band, pink

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149001590 Catalog Number : M50612

Device Description : Soft band, light blue

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149001743 Catalog Number : M50637

Device Description : Soft band, black

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

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