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eVu Senz App

by Thought Technology, Ltd.

Ref SA4502

eVu Senz App (SA4502) is a device classified as Class I in the EU and Class II in the US made by Thought Technology Ltd., registered in EUDAMED on 19 May 2022 (Basic UDI-DI 7540191000479H) and listed in FDA GUDID since 29 Oct 2019 (UDI-DI 07540191000487), 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 Number7540191000479H Basic UDI-DI 07540191000487UDI-DIDate19 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07540191000487 UDI-DI Date29 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7540191000479H registered 19 May 2022 Active
  • FDA GUDID UDI-DI 07540191000487 listed 29 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07540191000487
  2. Registered EUDAMED 7540191000479H

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  • Withdrawn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

Generic name
Psychophysiological biofeedback system
Device name
eVu TPS System
Model / reference
SA4502
Primary DI / UDI-DI
07540191000487
Basic UDI-DI
7540191000479H
FDA product code
HCC
EMDN code
Z12062401 Electromyographic biofeedback systems
GMDN term
Psychophysiological biofeedback system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
CA-MF-000024010
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS.

Other devices from Thought Technology Ltd.

See all devices from Thought Technology Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)