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Zensiv

by Oxmed International GmbH EUDAMED

Active European Union

Ref U2B4F, D1CLB10XV, U1FB10F, B2C525, P1NT10, D1FB10, C2B4, B2C510

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426033315U2-BYV Basic UDI-DIDate27 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Zensiv 2-piece Urostomy pouches
Zensiv 1-piece Ileostomy Convex pouches
Zensiv 1-piece Urostomy pouches
Zensiv Baseplates pre-cut
Zensiv Post-Op 1-piece pouch
Zensiv 1-piece Ileostomy pouches
Zensiv 2-piece Colostomy pouches
Zensiv Baseplates cut-to fit
Model / Reference
U2B4F, D1CLB10XV, U1FB10F, B2C525, P1NT10, D1FB10, C2B4, B2C510
Primary DI / UDI-DI
04260333151053, 04260333152142, 04260333152487, 04260333150902, 04260333150711, 04262432771217, 04260333151039, 04260333150896
Basic UDI-DI
426033315U2-BYV, 426033315D1-CV3, 426033315U1-FYY, 426033315B2-PCNH, 426033315P1-FXV, 426033315D1-FV9, 426033315C2-BUX, 426033315B2-CTFHD
Unit of Use DI
04260333157307, 04260333158328, 04260333158557, 04260333157154, 04260333156966, 04262432771200, 04260333157284, 04260333157147
EMDN Code
A10020402, A1001020202, A1001030102, A1002010402, A100199, A1001020102, A10020202
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

Show properties
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