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XGD Probe PR-XGD

by Otodynamics

Part of a family of 6 devices: see the family page

Ref PR-XGDModel PROBE

XGD Probe PR-XGD is a device classified as Class IIa in the EU and Class II in the US made by Otodynamics, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 506039617PROBEBU) and listed in FDA GUDID since 1 Apr 2023 (UDI-DI 05060396172199), 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 Number506039617PROBEBU Basic UDI-DI 05060396172199UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060396172199 UDI-DI Date1 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506039617PROBEBU registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 05060396172199 listed 1 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060396172199
  2. Registered EUDAMED 506039617PROBEBU

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  • Withdrawn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
XGD Ear Probe EUDAMED
XGD Probe GUDID
Generic name
Evoked-potential audiometer
Device name
Otodynamics Ear Probes
Model / reference
PR-XGD, PROBE
Primary DI / UDI-DI
05060396172199
Basic UDI-DI
506039617PROBEBU
Direct marketing DI
05060396172199
FDA product code
EWO, GWJ
EMDN code
Z12149001 Otoacoustic emissions equipment
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050, 882.1900
EU registration type
Standard device
EU market of registration
Austria
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: Evoked-potential audiometerOtoacoustic emission system, battery-powered

Similar devices in this category

Other devices filed under OTOACOUSTIC EMISSIONS EQUIPMENT.

Other devices from Otodynamics

See all devices from Otodynamics →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)