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Non-mydriatic Fundus Camera

by Crystalvue Medical Corporation 5 variants

Ref PolarisModel NFC-700

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 Number471987642FUNDUSCAMERAYG Basic UDI-DI 04719876420282UDI-DIDate18 Nov 2022RegisteredStatusActive

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  • Withdrawn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
Infrared Fundus Camera
Model / Reference
NFC-700, Polaris
Primary DI / UDI-DI
04719876420282
Basic UDI-DI
471987642FUNDUSCAMERAYG
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
TW-MF-000018351
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Crystalvue Medical Corporation

See all devices from Crystalvue Medical 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