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Roger 21 (02), (beige)

by Sonova AG

Ref 052-3469-D02V2Model Wireless HA receivers

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613389WRAS Basic UDI-DI 07612904378609UDI-DIDate13 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07612904378609 UDI-DI Date24 Aug 2017ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Roger 21 (02), (beige) EUDAMED
Phonak GUDID
Generic Name
Hearing aid enhanced audio device, teaching-environment
Device Name
Wireless HA receivers
Model / Ref / Catalog
Wireless HA receivers, 052-3469-D02V2
Primary DI / UDI-DI
07612904378609
Basic UDI-DI
07613389WRAS
FDA Product Code
ESD
EMDN Code
Y214580 Hearing aids or hearing devices - accessories
GMDN Term
Hearing aid enhanced audio device, teaching-environment
Device Class
Class I
Regulation Number
874.3300
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

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