Skip to content

MedRx AWRC

by Medrx, Inc.

Ref 8528574

MedRx AWRC 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_8528574_2Z) and listed in FDA GUDID since 1 Sep 2022 (UDI-DI 00810044583045), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081004458_8528574_2Z Basic UDI-DI 00810044583045UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810044583045 UDI-DI Date1 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004458_8528574_2Z registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 00810044583045 listed 1 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810044583045
  2. Registered EUDAMED 081004458_8528574_2Z

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  • Withdrawn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 AWRC EUDAMED
MedRx GUDID
Generic name
Tone audiometer
Model / reference
8528574 EUDAMED
MedRx AWRC GUDID
Primary DI / UDI-DI
00810044583045
Basic UDI-DI
081004458_8528574_2Z
Direct marketing DI
00810044583045
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
8528574
GUDID
MedRx AWRC
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)