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Cochlear™ Earhook Z544868

by Cochlear

Ref Z544868

Cochlear™ Earhook Z544868 is a Class III device made by Cochlear, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 9321502CP1000EarhookST) with CE/MDR certificate G70 078611 0123 valid until 21 Jan 2031, approved under FDA PMA P970051 on 25 Jun 1998 and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 09321502035316), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

21 Jan 2031

CE MDR certificate

FDA recalls

None ongoing

3 closed

Documents

2 certificates

Certifier TÜV SÜD Product Service GmbH

PMA P970051

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9321502CP1000EarhookST Basic UDI-DI 09321502035316UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502035316 UDI-DI Date28 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP970051 Date25 Jun 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9321502CP1000EarhookST registered 7 Oct 2026 Active· +1 more in the status table
  • FDA PMA P970051 decided 25 Jun 1998 Active
  • FDA GUDID UDI-DI 09321502035316 listed 28 Jun 2017 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • G70 078611 0123 Active Reissued

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    26 Nov 2025
    Expires
    21 Jan 2031
    Valid from
    22 Jan 2026
  • G70 078611 0123 Active Reissued Removed from EUDAMED

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    26 Nov 2025
    Expires
    21 Jan 2031
    Valid from
    22 Jan 2026

Recalls

3 recalls · FDA

    • Terminated Z-2155-2015 FDA Class II initiated 5 Jun 2015

    Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

    • Terminated Z-0003-2012 FDA Unclassified (pre-2012) initiated 16 Sep 2011

    Cochlear implant may shut down and cease to function.

    • Terminated Z-0119-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2009

    Cochlear implant device component was mis-labeled.

Timeline

8 dated events

  1. Approved FDA PMA P970051
  2. Recall initiated FDA recalls Z-0119-2010
  3. Recall initiated FDA recalls Z-0003-2012
  4. Recall initiated FDA recalls Z-2155-2015
  5. Listed FDA GUDID 09321502035316
  6. Certificate issued EUDAMED G70 078611 0123
  7. Registered EUDAMED 9321502CP1000EarhookST
  8. Certificate expires EUDAMED G70 078611 0123

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Cochlear® Earhook (Large, EH1, 3 pcs) EUDAMED
Cochlear™ Earhook GUDID
Generic name
Cochlear implant/auditory brainstem implant sound processor earhook
Device name
Cochlear™ Tamper Resistant Earhook
Model / Ref / Catalog
Z544868
Primary DI / UDI-DI
09321502035316
Basic UDI-DI
9321502CP1000EarhookST
Unit of use DI
09321502041645
PMA number
FDA product code
MCM
EMDN code
J0380 Auditory active-implantable devices - accessories
GMDN term
Cochlear implant/auditory brainstem implant sound processor earhook
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Cochlear implant/auditory brainstem implant sound processor earhook

Cleared under the same submission (P970051)

and 8 more cleared under P970051

Other devices from Cochlear

See all devices from Cochlear →

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)