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X8 System (Sleep Profiler, Sleep Profiler PSG2)

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref SP29-1006.LE(FRE)

by Advanced Brain Monitoring, Inc.

Identity

Trade Name
X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
Sleep Profiler PSG2 FDA UDI
Generic Name
Electroencephalograph FDA UDI
Device Name
X8 System EUDAMED
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French FDA UDI
Model / Reference
SP29-1006.LE(FRE) EUDAMEDFDA UDI
Description
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French FDA UDI

Identifiers

Primary DI / UDI-DI
00850063034227 EUDAMEDFDA UDI
Basic UDI-DI
0851113007SP29SPPYC EUDAMED
510(k) Number
K152040 FDA UDI
FDA Product Code
OMC FDA UDI
OLV FDA UDI
EMDN Code
N01010203 EEG HEADSETS EUDAMED
GMDN Term
Electroencephalograph FDA UDI

Classification

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

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

X8 System (Sleep Profiler, Sleep Profiler PSG2) by Advanced Brain Monitoring, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

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 f31c0bf2-1dd8-467c-b211-37824595adfb 61 fields · synced Oct 8, 2026
  • FDA UDI 727183d9-8c13-4e69-b925-6244c44faca2 35 fields · synced May 29, 2026