Mediso Medical Imaging Systems Ltd.

Certificate HZ 1662017-1

Rev. 0Issued

Valid until: Mar 9, 2031

Certificate HZ 1662017-1 is a valid Quality management system issued to Mediso Medical Imaging Systems Ltd. and registered in EUDAMED. Valid until March 9, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1662017-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1662017-10

Validity

Issued: Mar 10, 2026
Valid from: Mar 10, 2026
Valid until: Mar 9, 2031

Manufacturer

Manufacturer: Mediso Medical Imaging Systems Ltd.
Manufacturer SRN: HU-MF-000008325
Manufacturer country: Hungary

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

Z11029092 - VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE
Class IIa

Documents

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