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Unitron Brand 075-5867-11

by Sonova AG

Part of a family of 153 devices: see the family page

Ref 075-5867-11Model Sonova Charging Accessories

Unitron Brand 075-5867-11 is a device classified as Class I in the EU and Class II in the US made by Sonova AG, registered in EUDAMED on 5 Sep 2023 (Basic UDI-DI 07613389CHARGERHT) and listed in FDA GUDID since 18 Jul 2023 (UDI-DI 07613389544039), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613389CHARGERHT Basic UDI-DI 07613389544039UDI-DIDate5 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07613389544039 UDI-DI Date18 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 07613389CHARGERHT registered 5 Sep 2023 Active
  • FDA GUDID UDI-DI 07613389544039 listed 18 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613389544039
  2. Registered EUDAMED 07613389CHARGERHT

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  • Withdrawn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
Easy Line RS Charger - US EPS EUDAMED
Unitron Brand GUDID
Generic name
Noninvasive device battery charger
Device name
Sonova Charging Accessories
Model / Ref / Catalog
075-5867-11, Sonova Charging Accessories
Primary DI / UDI-DI
07613389544039
Basic UDI-DI
07613389CHARGERHT
FDA product code
OSM
EMDN code
Y214580 Hearing aids or hearing devices - accessories
GMDN term
Noninvasive device battery charger
Device class
Class I 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 Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Noninvasive device battery charger

Similar devices in this category

Other devices filed under HEARING AIDS OR HEARING DEVICES - ACCESSORIES.

Other devices from Sonova AG

See all devices from Sonova AG →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)