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05993022987709

by Medicontur Medical Engineering Ltd.

Part of a family of 328 devices: see the family page

Ref 05993022987709Model 860PTY

05993022987709 is a Class IIb device made by Medicontur Medical Engineering Ltd., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 599302860PTYU6) with CE/MDR certificate 2023-MDR/QS-046/B valid until 10 Nov 2028, active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

10 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2023-MDR/QS-046/B Date11 Sep 2026IssuedStatusActive expires 10 Nov 2028

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2023-MDR/QS-046/B Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    11 Sep 2026
    Expires
    10 Nov 2028
    Reason
    Other
  • 2023-MDR/TD-046/B Active Supplemented

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    11 Sep 2026
    Expires
    10 Nov 2028
    Reason
    Other

Timeline

5 dated events

  1. Registered EUDAMED 599302860PTYU6
  2. Certificate issued EUDAMED 2023-MDR/QS-046/B
  3. Certificate issued EUDAMED 2023-MDR/TD-046/B
  4. Certificate expires EUDAMED 2023-MDR/QS-046/B
  5. Certificate expires EUDAMED 2023-MDR/TD-046/B

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
860PTY, 05993022987709
Primary DI / UDI-DI
05993022987709
Basic UDI-DI
599302860PTYU6
EMDN code
P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
HU-MF-000024195

Similar devices in this category

Other devices filed under IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC.

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Properties

  • Supplied sterile
  • Implantable
Other properties (13, all answered No)