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X-Series System (Stat)

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref XS30-4301

by Advanced Brain Monitoring, Inc.

Identity

Trade Name
X-Series System (Stat) EUDAMED
X-Series FDA UDI
Generic Name
Patient monitoring system module, electroencephalographic FDA UDI
Device Name
X-Series System EUDAMED
Single-Use Strip Sensor Kit FDA UDI
Model / Reference
XS30-4301 EUDAMEDFDA UDI
Description
Single-Use Strip Sensor Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850015266614 EUDAMEDFDA UDI
Basic UDI-DI
0851113007XS30SPP2P EUDAMED
510(k) Number
K131383 FDA UDI
FDA Product Code
OMC FDA UDI
GWQ FDA UDI
EMDN Code
N01010203 EEG HEADSETS EUDAMED
GMDN Term
Patient monitoring system module, electroencephalographic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
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. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

X-Series System (Stat) by Advanced Brain Monitoring, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Brain Monitoring, Inc.
EUDAMED SRN
US-PR-000044717

Sources (2)

  • EUDAMED c83be300-eeb6-4d14-83b6-5d30a8b0d440 61 fields · synced Oct 6, 2026
  • FDA UDI 89b01f97-0317-4e7c-8bb6-6f6190ff1275 35 fields · synced May 29, 2026