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Trackit T4A

by Lifelines Ltd.

Ref 2800Model Trackit T4A EEG Amplifier, Trackit T4A

Trackit T4A (2800) is a device classified as Class IIa in the EU and Class II in the US made by Lifelines Ltd., registered in EUDAMED on 2 Oct 2025 (Basic UDI-DI B-05060275450653), cleared under FDA 510(k) K172271 on 4 May 2018 and listed in FDA GUDID since 26 Nov 2018 (UDI-DI 05060275450653), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172271

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-05060275450653 Basic UDI-DI 05060275450653UDI-DIDate2 Oct 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-05060275450653 Basic UDI-DI 05060275450653UDI-DIDate2 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060275450653 UDI-DI Date26 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK172271 Date4 May 2018IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05060275450653 registered 2 Oct 2025 Active· +1 more in the status table
  • FDA 510(k) K172271 decided 4 May 2018 Active
  • FDA GUDID UDI-DI 05060275450653 listed 26 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172271
  2. Listed FDA GUDID 05060275450653
  3. Registered EUDAMED B-05060275450653

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Electroencephalographic ambulatory recorder
Device name
Trackit T4A EEG Amplifier
Model / Ref / Catalog
Trackit T4A EEG Amplifier, 2800, Trackit T4A, T4A Kit
Primary DI / UDI-DI
05060275450653
Basic UDI-DI
B-05060275450653, 506027545T5P9
510(k) Number
FDA product code
GWL, GWQ
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalographic ambulatory recorder
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1835, 882.1400
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Trackit T4A EEG Amplifier
2800
Trackit T4A
GUDID
T4A Kit
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.

Manufacturer details

EUDAMED SRN
GB-MF-000020001
Authorised representative
Incereb Ltd IE-AR-000002462

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)