SLEEPINNOV TECHNOLOGY

Certificate FR26/00000136

Rev. 1Issued

Valid until: Apr 28, 2031

Certificate FR26/00000136 is a valid Quality management system issued to SLEEPINNOV TECHNOLOGY and registered in EUDAMED. Valid until April 28, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: FR26/00000136
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639FR26/000001361

Validity

Issued: Apr 28, 2026
Valid from: Apr 28, 2026
Valid until: Apr 28, 2031

Manufacturer

Manufacturer: SLEEPINNOV TECHNOLOGY
Manufacturer SRN: FR-MF-000016061
Manufacturer country: France

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa6

6 scopes

MDA0307, MDS1009
Class IIa
MDA0315
Class IIa
Haloa continuous positive airway pressure device for treatment obstructive sleep apnoea and hypopnoea syndrome
Class IIa
Haloa-Humid: accessory to humidify the air before it reaches the patient circuit(optional)
Class IIa
Haloa CLOUD: accessory intended to upload data from Haloa and download the data from cloud server by the intended users. (optional GSM fitted device)
Class IIa
Haloa BLE: accessory intended for users to change the therapeutic settings for Haloa device using bluetooth device (optional)
Class IIa

Documents

LanguagesEN