Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022505448

FEI Number

3022505448

Entity Name

SUNRISE SA

City/State/Country

NAMUR, BE

Establishment Address

Chaussee de marche 598 boite 2, NAMUR 5101, BE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

SUNRISE (Owner Number: 10084974)

Owner / Operator Contact Address

Chaussee de Marche 598 boite 2, Namur, BE-WNA 5101, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222262

PMA Number

N/A

All Registered Proprietary Names

Sunrise system SUNRISE DEVICE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRS	Device For Sleep Apnea Testing Based On Mandibular Movement	Ear, Nose, Throat	Class 2	868.2376	2022-04-22
QRS	Device For Sleep Apnea Testing Based On Mandibular Movement	Ear, Nose, Throat	Class 2	868.2376	2023-01-26

Official Correspondent

Cecile Roy

US Agent Details

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

Related Public Records

Same Entity

SUNRISE

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022505448. Last updated year: 2026. Please use registration number 3022505448 when referencing this establishment in official correspondence.