Medicontur Medical Engineering Ltd.

Certificate 2023-MDR/QS-048/A

Rev. 01Supplemented

Valid until: Nov 10, 2028

Certificate 2023-MDR/QS-048/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-048/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652023-MDR/QS-048/A01

Validity

Issued: Dec 12, 2024
Valid from: Dec 12, 2024
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: Yes
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

Supplemented

Supersedes

2023-MDR/TD-048IssuedNov 10, 2023 → Nov 10, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb38

38 scopes

IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Class IIb
IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHILIC ACRYLIC
Class IIb
IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Class IIb
IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

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