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Zensiv

by Oxmed International GmbH Germany EUDAMED

Ref U1CMB10F

EMDN A1001030202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426033315U1-CYS Basic UDI-DIDate27 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Zensiv Urostomy 1-Piece Convex pouch
Model / Reference
U1CMB10F
Primary DI / UDI-DI
04260333152227
Basic UDI-DI
426033315U1-CYS
Unit of Use DI
04260333158366
EMDN Code
A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000004970

Other devices from Oxmed International GmbH

See all devices from Oxmed International GmbH →

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 (1)

  • EUDAMED 885b80a8-a27e-455f-b706-c7f2683dc7f8 61 fields · synced 24 Oct 2026