Skip to content

Cochlear® Osia® 3 Aqua+ P1982729

by Cochlear

Ref P1982729

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

CE MDR

Valid until

8 Jul 2031

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 Number09321502082174 UDI-DI Date15 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberG70 078611 0252 Date9 Jul 2026IssuedStatusActive expires 8 Jul 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

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  • Withdrawn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® 3 Aqua+
Generic Name
Cochlear implant system waterproof kit
Device Name
Cochlear™ Osia® 3 Aqua+
Model / Ref / Catalog
P1982729
Primary DI / UDI-DI
09321502082174
Basic UDI-DI
9321502Osia3AquaPlus3X
Unit of Use DI
09321502086363
510(k) Number
FDA Product Code
PFO
EMDN Code
J0380 Auditory active-implantable devices - accessories
GMDN Term
Cochlear implant system waterproof kit
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
874.3340
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K260902)

Show all (12)

Other devices from Cochlear

See all devices from Cochlear →

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