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Holo

by St Andrews Medical Innovations Limited

Ref Holo

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506501522801HOLEV Basic UDI-DI 05065015228011UDI-DIDate9 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Holo Binocular Indirect Ophthalmoscope
Model / Reference
Holo
Primary DI / UDI-DI
05065015228011
Basic UDI-DI
506501522801HOLEV
Direct Marketing DI
05065015228011
EMDN Code
L1799 Ophthalmology instruments, reusable- other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000042204
Authorised representative
CS Life Sciences Europe Ltd IE-AR-000004113

Other devices from St Andrews Medical Innovations Limited

Properties

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