MEDORO s.r.o.

Certificate 2022-MDR/QS-020

Rev. 01Amended

Valid until: Sep 9, 2027

Certificate 2022-MDR/QS-020 is a valid Quality management system issued to MEDORO s.r.o. and registered in EUDAMED. Valid until September 9, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2022-MDR/QS-020
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652022-MDR/QS-02001

Validity

Issued: Mar 19, 2025
Valid from: Mar 19, 2025
Valid until: Sep 9, 2027

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
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: No
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Amended
Amended

Supersedes

2022-MDR/QS-020Quality management systemIssuedSep 9, 2022 → Sep 9, 2027

Scope coverage

Class IIb2

2 scopes

Picture archiving and communication systems
Class IIb
DEVICE
Class IIb