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WebApp

by RetinaLyze System A/S

Ref 4.5.7Model 4

Active European Union

CE MDR CE MDD

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 NumberB-05745000571017 Basic UDI-DI 05745000571017UDI-DIDate26 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-05745000571017 Basic UDI-DI 05745000571017UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
WebApp
RetinaLyze System
Model / Reference
4, 4.5.7
Primary DI / UDI-DI
05745000571017
Basic UDI-DI
B-05745000571017, 5745000571017X4
Direct Marketing DI
05745000571017
EMDN Code
V92, Z12120192
Device Class
Class I
Class IIa
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000019563

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