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R40 EEG Amplifier Kit

by Lifelines Limited

Ref 2600Model R40, R40 EEG Amplifier

R40 EEG Amplifier Kit (2600) is a device classified as Class IIa in the EU and Class II in the US made by Lifelines Limited, registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI 506027545R40CH), cleared under FDA 510(k) K151600 on 23 Oct 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05060275450424), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151600

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/MDD EUDAMED Number506027545R40CH Basic UDI-DI 05060275450424UDI-DIDate12 Aug 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number506027545R40CH Basic UDI-DI 05060275450424UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060275450424 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151600 Date23 Oct 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506027545R40CH registered 12 Aug 2026 Active· +1 more in the status table
  • FDA 510(k) K151600 decided 23 Oct 2015 Active
  • FDA GUDID UDI-DI 05060275450424 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151600
  2. Listed FDA GUDID 05060275450424
  3. Registered EUDAMED 506027545R40CH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
R40 EUDAMEDGUDID
R40 EEG Amplifier EUDAMED
Generic name
Electroencephalograph
Model / Ref / Catalog
R40, 2600, R40 EEG Amplifier, EEG Amplifier Kit
Primary DI / UDI-DI
05060275450424
Basic UDI-DI
506027545R40CH, B-05060275450424
510(k) Number
FDA product code
GWL
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1835
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
R40
2600
R40 EEG Amplifier
GUDID
EEG Amplifier 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.

Related devices

Category: Electroencephalograph

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

Other devices from Lifelines Limited

  • Trackit T4A

    Class II

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)