Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Address:FUERSTENWEG 77A,INNSBRUCK Tirol,AT

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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

Implant, Cochlear (MCM) (10)

Premarket Exempt

No Yes

Clear

DaCapo Frame brown - 09008737047382 Catalog Number :

Device Description : Audio Processor Rechargeable Battery Frame

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 Control Unit blue - 09008737048303 Catalog Number :

Device Description : Audio Processor

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 Control Unit red - 09008737048310 Catalog Number :

Device Description : Audio Processor

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 Control Unit brown - 09008737048327 Catalog Number :

Device Description : Audio Processor

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 Battery Pack blue - 09008737048518 Catalog Number :

Device Description : Audio Processor Battery Pack

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 Battery Pack red - 09008737048525 Catalog Number :

Device Description : Audio Processor Battery Pack

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 Battery Pack brown - 09008737048532 Catalog Number :

Device Description : Audio Processor Battery Pack

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 FM Battery Pack Cover beige - 09008737048815 Catalog Number :

Device Description : Audio Processor Battery Pack

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 FM Battery Pack Cover grey - 09008737048822 Catalog Number :

Device Description : Audio Processor Battery Pack

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

OPUS 2 FM Battery Pack Cover blue - 09008737048839 Catalog Number :

Device Description : Audio Processor Battery Pack Cover

Device Class : 3

Duns Number: 300764032

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

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