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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Medicontur Medical Engineering Ltd.

Certificate 2023-MDR/QS-046/A

Rev. 01Supplemented
Valid until
Nov 10, 2028

Certificate 2023-MDR/QS-046/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-046/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-046/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/QS-046IssuedNov 10, 2023 → Nov 10, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb14

14 scopes

  • IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
    Class IIb
  • IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC 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

Documents

LanguagesEN

Manufacturer

Manufacturer
Medicontur Medical Engineering Ltd.
Manufacturer SRN
HU-MF-000024195
Manufacturer country
Hungary

Covered devices

  • 599302860PAZ9Class IIb
    599302860PAZ9
  • 599302877PA2NClass IIb
    599302877PA2N
  • 599302860PAYSDClass IIb
    599302860PAYSD
  • 599302860PTYU6Class IIb
    599302860PTYU6
  • 599302860PETYNWClass IIb
    599302860PETYNW
  • 599302877PAYU9Class IIb
    599302877PAYU9
  • 599302877PTYW2Class IIb
    599302877PTYW2
  • 599302877PEYUMClass IIb
    599302877PEYUM
  • 599302877PETYRQClass IIb
    599302877PETYRQ
  • 599302860PT2JClass IIb
    599302860PT2J
  • 599302877PT3UClass IIb
    599302877PT3U
  • 599302860PEYSRClass IIb
    599302860PEYSR