Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026753386

FEI Number

3026753386

Entity Name

ONERA B.V.

City/State/Country

Eindhoven Noord-Brabant, NL

Establishment Address

Torenallee 42-54, Eindhoven Noord-Brabant 5617BD, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Onera B.V. (Owner Number: 10087157)

Owner / Operator Contact Address

Torenallee 42-54, Eindhoven, NL-NB 5617BD, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223573

PMA Number

N/A

All Registered Proprietary Names

Onera Sleep Test System 2 Onera STS 2 Onera SleepMap Onera STS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2025-12-27
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-12-27
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2026-05-20
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2023-12-14
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2023-12-14

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Onera B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Similar Registrations

Registration Number	Establishment Name	Location
3005733633	EPM GLOBAL SERVICES INC., DBA VEXOS	Markham Ontario, CA
3007389703	NOX MEDICAL	Reykjavik, IS
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US
3006125362	NEUROVIRTUAL USA, INC.	Fort Lauderdale, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026753386. Last updated year: 2026. Please use registration number 3026753386 when referencing this establishment in official correspondence.