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Trackit T4A

by Lifelines Limited

Ref 1600Model Trackit T4A

Trackit T4A (1600) is a device classified as Class IIa in the EU and Class II in the US made by Lifelines Limited, registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI 506027545T5P9), cleared under FDA 510(k) K172271 on 4 May 2018 and listed in FDA GUDID since 26 Nov 2018 (UDI-DI 05060275450646), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506027545T5P9 Basic UDI-DI 05060275450646UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060275450646 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 506027545T5P9 registered 14 Aug 2026 Active
  • FDA 510(k) K172271 decided 4 May 2018 Active
  • FDA GUDID UDI-DI 05060275450646 listed 26 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172271
  2. Listed FDA GUDID 05060275450646
  3. Registered EUDAMED 506027545T5P9

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Electroencephalographic ambulatory recorder
Model / Ref / Catalog
Trackit T4A, 1600, T4A
Primary DI / UDI-DI
05060275450646
Basic UDI-DI
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
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
1600
GUDID
T4A
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.

Related devices

Category: Electroencephalographic ambulatory recorder

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

Other devices from Lifelines Limited

Properties

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