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Non-Mydriatic Auto Fundus Camera AFC-1

by NIDEK.CO.Ltd.,

Ref FC013-0040

Expiring European Union

CE MDR

Valid until

1 Nov 2026

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

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 Number4987669231GB Basic UDI-DI 04987669204528UDI-DIDate15 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 4202074CE01 Expiring Supplemented Expires today

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    30 Jun 2026
    Expires
    1 Nov 2026
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Afc-1
Model / Reference
FC013-0040
Primary DI / UDI-DI
04987669204528
Basic UDI-DI
4987669231GB
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000040151
Authorised representative
NIDEK SA FR-AR-000000341

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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