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Cochlear P1357536

by Cochlear

Ref P1357536

Cochlear P1357536 is a Class III device made by Cochlear, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 9321502CP1000AquaPlusVC) 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 15 Jun 2019 (UDI-DI 09321502044103), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9321502CP1000AquaPlusVC Basic UDI-DI 09321502044103UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502044103 UDI-DI Date15 Jun 2019ListedStatusListed 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 9321502CP1000AquaPlusVC registered 6 Oct 2026 Active· +1 more in the status table
  • FDA PMA P970051 decided 25 Jun 1998 Active
  • FDA GUDID UDI-DI 09321502044103 listed 15 Jun 2019 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 09321502044103
  6. Certificate issued EUDAMED G70 078611 0123
  7. Registered EUDAMED 9321502CP1000AquaPlusVC
  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® Nucleus® 7 Aqua+ (Compact, 2 pcs) EUDAMED
Cochlear GUDID
Generic name
Hearing implant system sound processor case, reusable
Device name
Nucleus® 7 Aqua+
Model / Ref / Catalog
P1357536
Primary DI / UDI-DI
09321502044103
Basic UDI-DI
9321502CP1000AquaPlusVC
Unit of use DI
09321502046541
PMA number
FDA product code
MCM
EMDN code
J0380 Auditory active-implantable devices - accessories
GMDN term
Hearing implant system sound processor case, reusable
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hearing implant system sound processor case, reusable

Cleared under the same submission (P970051)

and 8 more cleared under P970051

Similar devices

Also classified as Hearing implant system sound processor case, reusable.

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