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Unity® Dx

by Cylite Pty Ltd

Ref UDXModel HP-OCT

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number93588630HPOCTYC Basic UDI-DI 09358863000004UDI-DIDate2 Sep 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  • Withdrawn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
HP-OCT and accessories
Model / Reference
HP-OCT, UDX
Primary DI / UDI-DI
09358863000004
Basic UDI-DI
93588630HPOCTYC
Direct Marketing DI
09358863000004
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
AU-MF-000008611
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Cylite Pty Ltd

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