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R40

by Lifelines Ltd.

Ref 1326Model R40

R40 (1326) 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-05060275450387), cleared under FDA 510(k) K151600 on 23 Oct 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05060275450387), active as of 24 Oct 2026.

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

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 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060275450387 Basic UDI-DI 05060275450387UDI-DIDate2 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060275450387 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 B-05060275450387 registered 2 Oct 2025 Active
  • FDA 510(k) K151600 decided 23 Oct 2015 Active
  • FDA GUDID UDI-DI 05060275450387 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151600
  2. Listed FDA GUDID 05060275450387
  3. Registered EUDAMED B-05060275450387

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Electroencephalograph
Device name
R40 EEG Amplifier
Model / Ref / Catalog
R40, 1326, EEG Amplifier
Primary DI / UDI-DI
05060275450387
Basic UDI-DI
B-05060275450387, 506027545R40CH
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
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
R40
1326
GUDID
EEG Amplifier
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

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

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Properties

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