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Spectral Optical Coherence Tomographer REVO2 FC 130

by OPTOPOL Technology Sp. z o.o.

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

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59032931411900FCEP Basic UDI-DI 05903293141038UDI-DIDate11 Dec 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Spectral Optical Coherence Tomographer
Model / Reference
REVO HR, REVO FC, REVO FC 130, REVO2 HR, REVO2 FC, REVO2 FC 130, REF 221-130
Primary DI / UDI-DI
05903293141038
Basic UDI-DI
59032931411900FCEP
Direct Marketing DI
05903293141038
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
EU 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

  • 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