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Cochlear® Osia® Fitting Software 3 (v3.0)

by Cochlear Limited

Ref P2101596

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

CE MDR

Valid until

30 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09321502074186 UDI-DI Date15 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number9321502OFS3Z9 Basic UDI-DI 09321502074186UDI-DIDate6 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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® Fitting Software 3 (v3.0) EUDAMED
Cochlear® Osia® Fitting Software 3 GUDID
Generic Name
Audiometric/hearing device software
Device Name
Cochlear™ Osia® Fitting Software 3
Model / Ref / Catalog
P2101596, v 3.0
Primary DI / UDI-DI
09321502074186
Basic UDI-DI
9321502OFS3Z9
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
P2101596
GUDID
v 3.0
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
AU-MF-000009890
Authorised representative
Cochlear Deutschland GmbH & Co. KG DE-AR-000006034

Other devices from Cochlear Ltd

See all devices from Cochlear Ltd →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • 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
  • Manufacturing Date: No