Cochlear Bone Anchored Solutions AB

Address:Konstruktionsvagen 14,Molnlycke 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, implanted (MAH) (6) Hearing aid, bone conduction (LXB) (4)

Premarket Exempt

No Yes

Clear

Baha - 09321502043885 Catalog Number : P1340896

Device Description : BA310 Abutment 10mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

BIA310 Implant 4mm with 6mm abutment - 09321502043892 Catalog Number : P1340888

Device Description : N/A

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

BIA310 Implant 4 mm with 14mm abutment - 09321502043908 Catalog Number : P1340893

Device Description : N/A

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

BIA310 Implant 4mm with 12mm abutment - 09321502043915 Catalog Number : P1340891

Device Description : N/A

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

BIA310 Implant 4mm with 10mm abutment - 09321502043922 Catalog Number : P1340890

Device Description : N/A

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

BIA310 Implant 4mm with 8mm abutment - 09321502043939 Catalog Number : P1340889

Device Description : N/A

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Baha® Fitting Software 5 - 09321502044097 Catalog Number : P1457850

Device Description : N/A

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502044998 Catalog Number : P1572994

Device Description : Baha SoundArc Hair Matching Colour Kit

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502045001 Catalog Number : P1573011

Device Description : Baha SoundArc Fun Colour Kit

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha 5 SuperPower Earhook 2+ (XS) - 09321502051408 Catalog Number : P1173605

Device Description : Retention device to hold Baha 5 SuperPower sound processor in Under-the-Ear position (UTE)

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

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