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Mi2000 TICI UNICO FLEX24 SL T 5 mm Implant Kit

by MED-EL Elektromedizinische Geräte GmbH

Ref 49361Model UNICOKit

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9008737PPUNICOKitWN Basic UDI-DI 09008737493615UDI-DIDate3 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
UNICOKit, 49361
Primary DI / UDI-DI
09008737493615
Basic UDI-DI
9008737PPUNICOKitWN
EMDN Code
J0301 Cochlear implants
Device Class
Class III
Medical Purpose
MDR Art. 2(1): intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, and — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability

Manufacturer details

EUDAMED SRN
AT-PR-000036933

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Properties

Other properties (1)

  • Sterile: No