Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013548547

FEI Number

3013548547

Entity Name

ONIRIS

City/State/Country

RUEIL MALMAISON Hauts-de-Seine, FR

Establishment Address

147 avenue Paul Doumer, RUEIL MALMAISON Hauts-de-Seine 92500, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ONIRIS (Owner Number: 10054416)

Owner / Operator Contact Address

147 avenue Paul Doumer, RUEIL MALMAISON, FR-NOTA 92500, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250353

PMA Number

N/A

All Registered Proprietary Names

ONIRIS Pro Oniris Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-03-16
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

ONIRIS

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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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3006786034	Innovative Health Technologies (NZ) Limited	Dunedin Otago, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013548547. Last updated year: 2026. Please use registration number 3013548547 when referencing this establishment in official correspondence.