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rtx1

by Imagine Eyes EUDAMED

Active European Union

Ref rtx1Model rtx1, rtx1-AOdetect, rtx1-spc, rtx1-spc-AOdetect, rtx1-spc-TFI, rtx1-spc-AOdetect-TFI

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-rtx-1RS Basic UDI-DIDate11 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
rtx1 adaptive optics retinal camera
Model / Reference
rtx1, rtx1-AOdetect, rtx1-spc, rtx1-spc-AOdetect, rtx1-spc-TFI, rtx1-spc-AOdetect-TFI
Primary DI / UDI-DI
D-rtx-1RS
Basic UDI-DI
B-rtx-1RS
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000004148

From the manufacturer

Manufacturer's product page: rtx1 retinal camera

Other devices from Imagine Eyes

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No