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Boots Hearingcare 2.0

by Sonova AG

Ref 088-0025-00020Model Sonova hearing aid fitting software

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07613389652529 UDI-DI Date25 Jan 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number07613389SWAQ Basic UDI-DI 07613389652529UDI-DIDate11 Dec 2022RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Boots Hearingcare 2.0 EUDAMED
Boots Hearingcare 2 GUDID
Generic Name
Audiometric/hearing device software
Device Name
Sonova hearing aid fitting software
Model / Ref / Catalog
Sonova hearing aid fitting software, 088-0025-00020, 2.0
Primary DI / UDI-DI
07613389652529
Basic UDI-DI
07613389SWAQ
FDA Product Code
OSM
EMDN Code
Y214599 Hearing aids - other
GMDN Term
Audiometric/hearing device software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305
Special Device Type
Software
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Sonova hearing aid fitting software
088-0025-00020
GUDID
2.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000015958
Authorised representative
Sonova Deutschland GmbH DE-AR-000006322

Other devices from Sonova AG

See all devices from Sonova AG →

Properties

  • Premarket Exempt
  • Serial 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No