Sleep Profiler Software

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref Sleep Profiler Portal Software

by Advanced Brain Monitoring, Inc.

Identity

Trade Name: Sleep Profiler EUDAMEDFDA UDI
Generic Name: Polysomnography analyser FDA UDI
Device Name: Sleep Profiler Software EUDAMED
Sleep Profiler Portal Software FDA UDI
Model / Reference: Sleep Profiler Portal Software EUDAMEDFDA UDI
Description: Sleep Profiler Portal Software FDA UDI

Identifiers

Primary DI / UDI-DI: 00851113007024 EUDAMEDFDA UDI
Basic UDI-DI: 0851113007SP42Q6 EUDAMED
510(k) Number: K120450 FDA UDI
K130007 FDA UDI
K153412 FDA UDI
FDA Product Code: OLZ FDA UDI
EMDN Code: Z12100592 POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term: Polysomnography analyser FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
Special Device Type: Software EUDAMED
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

The Sleep Profiler Software is a Class IIa medical device that functions as an EEG Sleep Monitor, bridging the gap between laboratory polysomnography and actigraphy. It provides EEG, EOG and EMG signal features needed to characterize by-stage sleep time through three frontopolar channels.

The lightweight, wireless device is designed for self-application in the home with acquisition across multiple nights. It is not sterile, not implantable, and is not reusable. The device has FDA 510K clearance and MDR authorization, with product code OLZ and nomenclature code Z12100592.

Frequently asked questions

What is the Sleep Profiler Software used for?

The Sleep Profiler Software functions as an EEG Sleep Monitor, bridging the gap between laboratory polysomnography and actigraphy. It provides EEG, EOG and EMG signal features needed to characterize by-stage sleep time through three frontopolar channels.

How is the Sleep Profiler supplied and is it reusable?

The Sleep Profiler is a lightweight, wireless device designed for self-application in the home with acquisition across multiple nights. It is not sterile, not implantable, and is not reusable, making it suitable for single-use home sleep studies.

What are the regulatory approvals for the Sleep Profiler?

The Sleep Profiler has FDA 510K clearance and MDR authorization, with product code OLZ and nomenclature code Z12100592. It is classified as a Class IIa medical device, indicating moderate risk and specific regulatory controls.

How does the Sleep Profler differ from traditional polysomnography?

Unlike traditional polysomnography which typically requires an in-laboratory setting with multiple sensors, the Sleep Profler is designed for home use with self-application. It captures essential EEG, EOG and EMG signals through just three frontopolar channels, making it more convenient for patients.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sleep Profiler - Advanced Brain Monitoring, Advanced Brain Monitoring, Acquisition Marks New Phase for Advanced Brain Monitoring

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K130007	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K120450	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K153412	Class IIa	Active
EUDAMED	European Union	CE/MDR	0851113007SP42Q6	Class IIa	Active

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Manufacturer

Manufacturer: Advanced Brain Monitoring, Inc.
EUDAMED SRN: US-MF-000011252
Authorised Representative: MPS Medical Product Service GmbH DE-AR-000005009

Sources (3)

EUDAMED 5c1866bf-4221-4503-a58a-346b2a6060e1 61 fields · synced Oct 7, 2026
FDA UDI 454b6a85-b79e-4705-92c3-40337621c909 34 fields · synced May 29, 2026
FDA 510(k) K130007 1 fields · synced May 18, 2026