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Cystoflex™ Standard Deflection

by Axess Vision Technology United States EUDAMED

Ref 11010011

EMDN Z12020701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3664977EMDNZ12020701P8 Basic UDI-DIDate26 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
11010011
Primary DI / UDI-DI
03664977000059
Basic UDI-DI
3664977EMDNZ12020701P8
EMDN Code
Z12020701 Cystoscopes
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003039

Other devices from Axess Vision Technology

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 (1)

  • EUDAMED 4db598ab-ac17-47f8-b56d-47435d673120 61 fields · synced 22 Oct 2026