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Ultra-widefield Retinal Slit Scanner GAIA

by Topcon Corporation

Ref 1070437-01

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 Number4560126260020TV Basic UDI-DI 04560126268372UDI-DIDate21 Oct 2021RegisteredStatusActive

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  • Withdrawn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
Retinal Camera
Model / Reference
1070437-01
Primary DI / UDI-DI
04560126268372
Basic UDI-DI
4560126260020TV
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000003928
Authorised representative
Topcon Europe Medical BV NL-AR-000000441

Other devices from Topcon Corporation

See all devices from Topcon Corporation →

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