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 (LXB) (6) Hearing aid, bone conduction, implanted (MAH) (4)

Premarket Exempt

No Yes

Clear

Baha - 09321502040884 Catalog Number : P807177

Device Description : Baha SoundArc Large

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502040891 Catalog Number : P807178

Device Description : Baha SoundArc Extra Large

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502040907 Catalog Number : P807181

Device Description : Baha SoundArc Connector disc

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502041096 Catalog Number : P1129017

Device Description : Baha 5 Sound Processor Tamper-proof battery door 3 pcs

Device Class :

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 3

Baha - 09321502043748 Catalog Number : P1316179

Device Description : Cochlear Magnetic battery removal tool

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502043755 Catalog Number : P1324401

Device Description : Baha SoundArc Extra Small

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502043847 Catalog Number : P1340894

Device Description : BA310 Abutment 6 mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Baha - 09321502043854 Catalog Number : P1340898

Device Description : BA310 Abutment 14 mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Baha - 09321502043861 Catalog Number : P1340895

Device Description : BA310 Abutment 8mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

Baha - 09321502043878 Catalog Number : P1340897

Device Description : BA310 Abutment 12mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : MAH

Prescription Use : Yes

Device Count : 1

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