Trackit T4

Ref 2705Model Trackit T4

Trackit T4 (2705) is an electroencephalographic ambulatory recorder (EU MDR Class IIa; FDA Class II) made by Lifelines Ltd., registered in EUDAMED on 2 Oct 2025 (Basic UDI-DI 506027545T4P7), cleared under FDA 510(k) K172271 on 4 May 2018 (1 earlier submission) and listed in FDA GUDID since 23 Feb 2018 (UDI-DI 05060275450554), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172271

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number506027545T4P7 Basic UDI-DI 05060275450554UDI-DI	Date2 Oct 2025Registered	StatusActive
United States	FDA 510(k) GUDID from GUDID	NumberK172271	Date4 May 2018Issued	StatusActive
United States	GUDID listing GUDID	Number05060275450554 UDI-DI	Date23 Feb 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK151600	Date23 Oct 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 506027545T4P7 — open Devices and search for it
AccessGUDID record UDI-DI 05060275450554
FDA 510(k) database 510(k) number K172271
FDA 510(k) database 510(k) number K151600

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 506027545T4P7 registered 2 Oct 2025 Active
FDA 510(k) K172271 decided 4 May 2018 Active· +1 more in the status table
FDA GUDID UDI-DI 05060275450554 listed 23 Feb 2018 Listed

Timeline

4 dated events

23 Oct 2015 Cleared FDA 510(k) K151600
23 Feb 2018 Listed FDA GUDID 05060275450554
4 May 2018 Cleared FDA 510(k) K172271
2 Oct 2025 Registered EUDAMED 506027545T4P7

Coverage

2 jurisdictions

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Withdrawn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 / reference: Trackit T4 EUDAMED
2705 EUDAMED
T4-68 + BT Kit GUDID

Primary DI / UDI-DI: 05060275450554
Basic UDI-DI: 506027545T4P7
510(k) Number: K151600
K172271
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

Field	EUDAMED	GUDID
Model / reference	EUDAMED Trackit T4 2705	GUDID T4-68 + BT Kit
Device class	EUDAMED 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

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

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Trackit SOLO

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Properties

Prescription use
Serial number

Other properties (23, all answered No)