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X8 System (Sleep Profiler, Sleep Profiler PSG2)

by Advanced Brain Monitoring, Inc. 17 variants

Part of a family of 22 devices: see the family page

Ref SP40-4225.1

X8 System (Sleep Profiler, Sleep Profiler PSG2) (SP40-4225.1) is a device classified as Class IIa in the EU and Class II in the US made by Advanced Brain Monitoring, Inc., registered in EUDAMED on 22 May 2025 (Basic UDI-DI 0851113007SP29QE), cleared under FDA 510(k) K152040 on 30 Oct 2015 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851113007222), 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) K152040

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851113007SP29QE Basic UDI-DI 00851113007222UDI-DIDate22 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00851113007222 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK152040 Date30 Oct 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0851113007SP29QE registered 22 May 2025 Active
  • FDA 510(k) K152040 decided 30 Oct 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00851113007222 listed 24 Sep 2016 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K120447
  2. Cleared FDA 510(k) K130013
  3. Cleared FDA 510(k) K152040
  4. Listed FDA GUDID 00851113007222
  5. Registered EUDAMED 0851113007SP29QE

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  • Withdrawn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

Trade name
X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
Sleep Profiler GUDID
Generic name
Patient monitoring system module, electroencephalographic
Device name
X8 System
Model / reference
SP40-4225.1
Primary DI / UDI-DI
00851113007222
Basic UDI-DI
0851113007SP29QE
510(k) Number
FDA product code
OLV, OMC
EMDN code
N01010203 EEG headsets
GMDN term
Patient monitoring system module, electroencephalographic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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
US-MF-000011252
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)