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Bio-Sil Fa Hds

by Optilab S.R.L. Italy EUDAMED

Ref 001Model BIO-SIL

EMDN Q02100402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805750736A01FV Basic UDI-DIDate17 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Bio-Sil
Model / Reference
BIO-SIL, 001
Primary DI / UDI-DI
08057507360085
Basic UDI-DI
805750736A01FV
EMDN Code
Q02100402 Contact lenses - non hydrogel
Device Class
Class IIa
Special Device Type
Made to order Rigid Gas Permeable (RGP) contact lenses
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026824

Other devices from Optilab S.R.L.

See all devices from Optilab S.R.L. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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

Sources (1)

  • EUDAMED 56e2544f-7829-473e-9735-d60d8542b78c 61 fields · synced 22 Oct 2026