MediTuner AB

Certificate HZ 2458490-1

Rev. 1Issued

Valid until: Apr 16, 2030

Certificate HZ 2458490-1 is a valid Quality management system issued to MediTuner AB and registered in EUDAMED. Valid until April 16, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2458490-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2458490-11

Validity

Issued: Apr 23, 2025
Valid from: Apr 23, 2025
Valid until: Apr 16, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

V92 – MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES SOFTWARE FOR DIAGNOSING AND TREATMENT OF LUNG DISEASES
Class IIb

Documents

LanguagesEN