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Guide Sheaths Accessory Stoppers

by Lys Medical Belgium EUDAMED

Ref STOPACK20, STOPACK1

EMDN Z12020885

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP10078IRIS.GSM87 Basic UDI-DIDate1 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Iriscope Guide Sheath
Model / Reference
STOPACK20, STOPACK1
Primary DI / UDI-DI
112038471236, 112084296526
Basic UDI-DI
PP10078IRIS.GSM87
EMDN Code
Z12020885 Pulmonary endoscopic instruments - consumables
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000036

Other devices from Lys Medical

See all devices from Lys Medical →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED a6e2da70-e590-4fea-851e-508845a5c8bd 61 fields · synced 22 Oct 2026
  • EUDAMED 112084296526|PP10078IRIS.GSM87 61 fields · synced 13 Jul 2026