Medicontur Medical Engineering Ltd.

Certificate 2023-MDR/QS-047/A

Rev. 01Amended

Valid until: Nov 10, 2028

Certificate 2023-MDR/QS-047/A is a valid Quality management system issued to Medicontur Medical Engineering Ltd. and registered in EUDAMED. Valid until November 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-047/A
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652023-MDR/QS-047/A01

Validity

Issued: Dec 22, 2025
Valid from: Dec 22, 2025
Valid until: Nov 10, 2028

Notified body

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

Characteristics

Sterile: Yes
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: Basic UDI-DI data and Class IIb

History

Status changes

Amended

Supersedes

2023-MDR/QS-047IssuedNov 10, 2023 → Nov 10, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb6

6 scopes

IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN