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Spectral Optical Coherence Tomographer REVO2 FC

by OPTOPOL Technology Sp. z o.o. EUDAMED

Active European Union

Ref REF 221-80Model REVO HR, REVO FC, REVO FC 130, REVO2 HR, REVO2 FC, REVO2 FC 130

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59032931411900FCEP Basic UDI-DIDate11 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Spectral Optical Coherence Tomographer
Model / Reference
REVO HR, REVO FC, REVO FC 130, REVO2 HR, REVO2 FC, REVO2 FC 130, REF 221-80
Primary DI / UDI-DI
05903293141045
Basic UDI-DI
59032931411900FCEP
Direct Marketing DI
05903293141045
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000004770

Other devices from Optopol Technology Sp Z O O

See all devices from Optopol Technology Sp Z O O →

Properties

Show properties
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No