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X8 System (Sleep Profiler, Sleep Profiler PSG2)

by Advanced Brain Monitoring, Inc. 2 variants

Ref SP40-4225.10

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152040↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851113007SP29QE Basic UDI-DI 10851113007229UDI-DIDate22 May 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK152040 Date30 Oct 2015IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device Name
X8 System
Model / Reference
SP40-4225.10
Primary DI / UDI-DI
10851113007229
Basic UDI-DI
0851113007SP29QE
EMDN Code
N01010203 EEG headsets
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

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

Other devices from Advanced Brain Monitoring, Inc.

See all devices from Advanced Brain Monitoring, Inc. →

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No