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MedRx Kiosk

by Medrx, Inc.

Ref 8530661

MedRx Kiosk is a device classified as Class IIa in the EU and Class II in the US made by Medrx, Inc., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 081004458_8530661_YC) and listed in FDA GUDID since 25 Feb 2022 (UDI-DI 00810044582963), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081004458_8530661_YC Basic UDI-DI 00810044582963UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810044582963 UDI-DI Date25 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004458_8530661_YC registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 00810044582963 listed 25 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810044582963
  2. Registered EUDAMED 081004458_8530661_YC

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  • Withdrawn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
MedRx Kiosk EUDAMED
MedRx GUDID
Generic name
Tone audiometer
Model / reference
8530661 EUDAMED
MedRx Kiosk GUDID
Primary DI / UDI-DI
00810044582963
Basic UDI-DI
081004458_8530661_YC
Direct marketing DI
00810044582963
FDA product code
EWO
EMDN code
Z121401 Audiometers
GMDN term
Tone audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8530661
GUDID
MedRx Kiosk
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: Tone audiometer

Similar devices in this category

Other devices filed under AUDIOMETERS.

Other devices from Medrx, Inc.

See all devices from Medrx, Inc. →

Properties

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