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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/TD-046/A

Rev. 01Supplemented
Valid until
Nov 10, 2028

Certificate 2023-MDR/TD-046/A is a valid Technical documentation 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/TD-046/A
Certificate type
Technical documentation
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
22652023-MDR/TD-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
—
Human tissues
—
Animal tissues
—
In vitro diagnostics
—
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
—
SPP applicable
—
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

Status changes

  • Supplemented

Supersedes

  • 2023-MDR/TD-046IssuedNov 10, 2023 → Nov 10, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified12

12 scopes

  • Device
    599302860PAZ9
  • Device
    599302860PT2J
  • Device
    599302877PA2N
  • Device
    599302877PT3U
  • Device
    599302860PAYSD
  • Device
    599302860PTYU6
  • Device
    599302860PEYSR
  • Device
    599302860PETYNW
  • Device
    599302877PAYU9
  • Device
    599302877PTYW2
  • Device
    599302877PEYUM
  • Device
    599302877PETYRQ

Documents

LanguagesEN

Manufacturer

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

Covered devices

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

Linked SSCPs

  • SSCP SSCP_01_D