Skip to content

X8 System (Sleep Profiler, Sleep Profiler PSG2)

by Advanced Brain Monitoring, Inc. 17 variants

Ref SP29-1015.LE

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851113007SP29QE Basic UDI-DI 00850063034128UDI-DIDate22 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850063034128 UDI-DI Date28 Jan 2025ListedStatusListed GUDID: in commercial distribution

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 22 Oct 2026.

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  • Withdrawn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
X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
Sleep Profiler GUDID
Generic Name
Electroencephalograph
Device Name
X8 System
Model / Reference
SP29-1015.LE
Primary DI / UDI-DI
00850063034128
Basic UDI-DI
0851113007SP29QE
Direct Marketing DI
00851113007949
510(k) Number
FDA Product Code
OMC, OLV
EMDN Code
N01010203 EEG headsets
GMDN Term
Electroencephalograph
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1400
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

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
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No