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Open 30 Presbyo

by Safilens SRL Unipersonale

Ref MF45HYAModel F45HYA

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803261059F45HYATG Basic UDI-DI 803261059MF45HYA4DUDI-DIDate24 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
F45HYA, MF45HYA
Primary DI / UDI-DI
803261059MF45HYA4D
Basic UDI-DI
803261059F45HYATG
EMDN Code
Q02100402 Contact lenses - non hydrogel
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010079

Other devices from Safilens SRL Unipersonale

See all devices from Safilens SRL Unipersonale →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No