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X8 System (Sleep Profiler, Sleep Profiler PSG2)

by Advanced Brain Monitoring, Inc. EUDAMEDGUDID

Active European Union

Ref SP29-1018.LE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850063034418 UDI-DIDate25 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0851113007SP29SPPYC Basic UDI-DIDate23 May 2025RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
Sleep Profiler PSG2 GUDID
Generic Name
Electroencephalograph
Device Name
X8 System
Model / Reference
SP29-1018.LE
Primary DI / UDI-DI
00850063034418
Basic UDI-DI
0851113007SP29SPPYC
510(k) Number
FDA Product Code
OMC, OLV
EMDN Code
N01010203 EEG headsets
GMDN Term
Electroencephalograph
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
882.1400
Medical Purpose
The X8 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit, and display physiological signals from adult patients. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 system only acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000044717

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Properties

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

Other properties (9)

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