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) (7) Hearing Aid, Bone Conduction, Implanted (MAH) (3)

Premarket Exempt

Clear

Ponto - 05712149002207 Catalog Number : M50739

Device Description : Soft band, red, bilateral

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002436 Catalog Number : M50784

Device Description : Implant, 3 mm, with abutment, 6 mm

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002443 Catalog Number : M50785

Device Description : Implant, 4 mm, with abutment, 9 mm

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002832 Catalog Number : M50872

Device Description : Ponto Pro Power, right, mocca brown

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002849 Catalog Number : M50873

Device Description : Ponto Pro Power, left, mocca brown

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002856 Catalog Number : M50874

Device Description : Ponto Pro Power, right, chroma beige

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002863 Catalog Number : M50875

Device Description : Ponto Pro Power, left, chroma beige

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002948 Catalog Number : M50902

Device Description : Ponto Pro Power, right, white silver

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149002955 Catalog Number : M50903

Device Description : Ponto Pro Power, left, white silver

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Ponto - 05712149003808 Catalog Number : M51122

Device Description : Wide countersink, 4 mm

Device Class : 2

Duns Number: 554563994

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

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