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Trigno Wireless Biofeedback System DS-T03

by Delsys, Inc.

Trigno Wireless Biofeedback System DS-T03 is a Class II device made by Delsys, Inc., registered in EUDAMED and listed in FDA GUDID since 16 Feb 2018 (UDI-DI 00851679007209), 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
United StatesGUDID listing GUDID Number00851679007209 UDI-DI Date16 Feb 2018ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 00851679007209 listed 16 Feb 2018 Listed

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  • Withdrawn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
Trigno Wireless Biofeedback System
Generic name
Biofeedback system
Model / reference
DS-T03
Primary DI / UDI-DI
00851679007209
FDA product code
HCC
GMDN term
Biofeedback system
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Biofeedback system

Similar devices

Other devices filed under FDA product code HCC (Device, Biofeedback).

Other devices from Delsys, Inc.

See all devices from Delsys, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)