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Iriscope System - Video-Endoscope, Medical Cart and Monitor

by Lys Medical

Ref 0300, 112058717736, 112058718302

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP10078IRISYST82 Basic UDI-DI Date31 May 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Iriscope System - Video-Endoscope, Medical Cart and Monitor
Iriscope System
Device Name
Iriscope System - Video-Endoscope, Monitor and Medical Cart
Model / Reference
0300, 112058717736, 112058718302
Primary DI / UDI-DI
111877587158, 112058717736, 112058718302
Basic UDI-DI
PP10078IRISYST82
EMDN Code
Z12020406, Z12020480, Z12020802, Z12029003
Device Class
Class I
Medical Purpose
System intended to visualize the respiratory tracts down to peripheral bronchi. It is intended to be used during an endoscopic procedure. The system is composed of a small video-endoscope and its processor for visualization in small tracts, a monitor to display the image, and a medical cart to support the processor and monitor.

Manufacturer details

EUDAMED SRN
BE-PR-000041516

Other devices from Lys Medical

See all devices from Lys Medical →

Properties

Other properties (1)

  • Sterile: No