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Atlantis Atlantis 2eb+

by BrainMaster Technologies, Inc.

Ref 390-025Model Discovery 20

Atlantis Atlantis 2eb+ (390-025) is a device classified as Class IIa in the EU and Class II in the US made by BrainMaster Technologies, Inc., registered in EUDAMED on 27 Jul 2026 (Basic UDI-DI 0852391007EEG2X) and listed in FDA GUDID since 15 Aug 2023 (UDI-DI 00852391007034), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0852391007EEG2X Basic UDI-DI 00852391007034UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00852391007034 UDI-DI Date15 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0852391007EEG2X registered 27 Jul 2026 Active
  • FDA GUDID UDI-DI 00852391007034 listed 15 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00852391007034
  2. Registered EUDAMED 0852391007EEG2X

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Atlantis 2EB+ EUDAMED
Atlantis GUDID
Generic name
Electroencephalograph
Device name
Discovery 20
Model / Ref / Catalog
Discovery 20, 390-025, Atlantis 2eb+
Primary DI / UDI-DI
00852391007034
Basic UDI-DI
0852391007EEG2X
Direct marketing DI
00852391007034
FDA product code
HCC
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5050
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Discovery 20
390-025
GUDID
Atlantis 2eb+
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.

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Other devices filed under ELECTROENCEPHALOGRAPHS.

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Properties

  • Measuring function
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)