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X-Series System (Stat)

by Advanced Brain Monitoring, Inc. 10 variants

Ref XS24-4321, 30-4200, XS02-4105, 30-4220, 30-1001.LE, 30-1001, 30-4201, XS02-4103

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 Number0851113007XS30SPP2P Basic UDI-DI Date23 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00851113007895 UDI-DI Date12 Apr 2018ListedStatusListed 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  • Withdrawn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
X-Series System (Stat) EUDAMED
X-Series GUDID
Generic Name
Analytical scalp electrode, single-use
Device Name
X-Series System
Model / Reference
XS24-4321, 30-4200, XS02-4105, 30-4220, 30-1001.LE, 30-1001, 30-4201, XS02-4103
Primary DI / UDI-DI
00851113007895, 00851113007376, 10850015266888, 00851113007765, 00850015266249, 00851113007345, 00851113007383, 10851113007359
Basic UDI-DI
0851113007XS30SPP2P, 0851113007XS30ACCVR, 0851113007XS30RH
Direct Marketing DI
00850015266249
00851113007345
510(k) Number
FDA Product Code
GWQ, OMC
EMDN Code
N01010203 EEG headsets
GMDN Term
Analytical scalp electrode, single-use
Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation Number
882.1400
EU market of registration
Ireland
Medical Purpose
The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electro-encephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series 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 IIa
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000044717

Other devices from Advanced Brain Monitoring, Inc.

See all devices from Advanced Brain Monitoring, Inc. →

Properties

  • Single Use
  • Measuring Function NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Convenience Kit
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No