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Unitron 050-6463-P6

by Unitron Hearing Division

Ref 050-6463-P6Model Sonova RIC hearing aids

Unitron 050-6463-P6 is a device classified as Class IIa in the EU and Class II in the US made by Unitron Hearing Division, registered in EUDAMED on 12 Dec 2022 (Basic UDI-DI 07613389RICWJ) and listed in FDA GUDID since 18 Oct 2021 (UDI-DI 07613389515732), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613389RICWJ Basic UDI-DI 07613389515732UDI-DIDate12 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07613389515732 UDI-DI Date18 Oct 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 07613389RICWJ registered 12 Dec 2022 Active
  • FDA GUDID UDI-DI 07613389515732 listed 18 Oct 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613389515732
  2. Registered EUDAMED 07613389RICWJ

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  • Withdrawn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
Moxi B1-RT (platinum) EUDAMED
Unitron GUDID
Generic name
Air-conduction hearing aid, receiver-in-canal
Device name
Sonova RIC hearing aids
Model / Ref / Catalog
050-6463-P6, Sonova RIC hearing aids
Primary DI / UDI-DI
07613389515732
Basic UDI-DI
07613389RICWJ
FDA product code
OSM
EMDN code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN term
Air-conduction hearing aid, receiver-in-canal
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.3305
EU registration type
Standard device
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

Similar devices in this category

Other devices filed under BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE).

Other devices from Unitron Hearing Division

See all devices from Unitron Hearing Division →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)