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Nucleus Z294703

by Cochlear

Ref Z294703Model CR230

Nucleus Z294703 is a hearing aid/implant system remote control (EU MDR Class III; FDA Class III; FDA product code MCM, Implant, Cochlear) made by Cochlear, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 9321502CR230KY) with CE/MDR certificate G70 078611 0158 valid until 5 Apr 2028, approved under FDA PMA P970051 on 25 Jun 1998 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 09321502022552), 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

5 Apr 2028

CE MDR certificate

FDA recalls

None ongoing

3 closed

Documents

1 certificate

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 Number9321502CR230KY Basic UDI-DI 09321502022552UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502022552 UDI-DI Date24 Sep 2014ListedStatusListed 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 9321502CR230KY registered 9 Oct 2026 Active· +1 more in the status table
  • FDA PMA P970051 decided 25 Jun 1998 Active
  • FDA GUDID UDI-DI 09321502022552 listed 24 Sep 2014 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 078611 0158 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    11 Sep 2025
    Expires
    5 Apr 2028
    Reason
    Add device or group

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. Listed FDA GUDID 09321502022552
  5. Recall initiated FDA recalls Z-2155-2015
  6. Certificate issued EUDAMED G70 078611 0158
  7. Registered EUDAMED 9321502CR230KY
  8. Certificate expires EUDAMED G70 078611 0158

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® Nucleus® CR230 Remote Assistant EUDAMED
Nucleus GUDID
Generic name
Hearing aid/implant system remote control
Device name
Nucleus® CR230 Remote Assistant
Model / Ref / Catalog
Z294703, CR230
Primary DI / UDI-DI
09321502022552
Basic UDI-DI
9321502CR230KY
PMA number
FDA product code
MCM
EMDN code
J0380 Auditory active-implantable devices - accessories
GMDN term
Hearing aid/implant system remote control
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hearing aid/implant system remote control

Cleared under the same submission (P970051)

and 8 more cleared under P970051

Similar devices in this category

Other devices filed under AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES.

Other devices from Cochlear

See all devices from Cochlear →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)