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MedRx WREM

by Medrx, Inc.

Ref 8537982

MedRx WREM is a device classified as Class I in the EU and Class II in the US made by Medrx, Inc., registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 081004458_8537982_3W) and listed in FDA GUDID since 7 May 2024 (UDI-DI 00810044583182), 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_8537982_3W Basic UDI-DI 00810044583182UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810044583182 UDI-DI Date7 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004458_8537982_3W registered 22 Sep 2026 Active
  • FDA GUDID UDI-DI 00810044583182 listed 7 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810044583182
  2. Registered EUDAMED 081004458_8537982_3W

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  • Withdrawn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 WREM EUDAMED
MedRx GUDID
Generic name
Audiometric/hearing aid tester
Model / reference
8537982 EUDAMED
MedRx WREM GUDID
Primary DI / UDI-DI
00810044583182
Basic UDI-DI
081004458_8537982_3W
Direct marketing DI
00810044583182
FDA product code
ETW
EMDN code
Z12149099 Various ENT instruments - other
GMDN term
Audiometric/hearing aid tester
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.3310
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
8537982
GUDID
MedRx WREM
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: Audiometric/hearing aid tester

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS - OTHER.

Other devices from Medrx, Inc.

See all devices from Medrx, Inc. →

Properties

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