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Cochlear® Osia® Smart App v1.2

by Cochlear

Ref P1340352

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

6 Dec 2028

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09321502083577 UDI-DI Date15 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberG70 078611 0203 Date1 Jul 2026IssuedStatusActive expires 6 Dec 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 078611 0203 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    1 Jul 2026
    Expires
    6 Dec 2028
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Cochlear® Osia® Smart App (iOS, v1.2) EUDAMED
Cochlear® Osia® Smart App GUDID
Generic Name
Audiometric/hearing device software
Device Name
Cochlear™ Osia® Smart App
Model / Ref / Catalog
P1340352, v1.2
Primary DI / UDI-DI
09321502083577
Basic UDI-DI
9321502OsiaSmartAppDQ
510(k) Number
FDA Product Code
PFO
EMDN Code
J0380 Auditory active-implantable devices - accessories
GMDN Term
Audiometric/hearing device software
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
874.3340
Special Device Type
Software
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
P1340352
GUDID
v1.2
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K260902)

Show all (12)

Other devices from Cochlear

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No