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MedRx Avant REM Speech+

by Medrx, Inc.

Ref 8511800

MedRx Avant REM Speech+ 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_8511800_XA) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810044580037), 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_8511800_XA Basic UDI-DI 00810044580037UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810044580037 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004458_8511800_XA registered 22 Sep 2026 Active
  • FDA GUDID UDI-DI 00810044580037 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810044580037
  2. Registered EUDAMED 081004458_8511800_XA

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  • Withdrawn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
Avant REM Speech+ EUDAMED
MedRx GUDID
Generic name
Audiometric/hearing aid tester
Model / reference
8511800 EUDAMED
Avant REM Speech+ GUDID
Primary DI / UDI-DI
00810044580037
Basic UDI-DI
081004458_8511800_XA
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
8511800
GUDID
Avant REM Speech+
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)