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Trio Genii with Sil2 Silicone flange

by Trio Healthcare Ltd United Kingdom EUDAMED

Ref TR321NModel Mini Closed Light EMDN A1001010102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506036142GENIIOSTOMYLK Basic UDI-DIDate26 Aug 2022RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
Mini Closed Light, TR321N
Primary DI / UDI-DI
05060361420461
Basic UDI-DI
506036142GENIIOSTOMYLK
EMDN Code
A1001010102 One-piece colostomy bags for non-retracted stoma, flat, with tissue cover
Device Class
Class I
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
GB-MF-000020603
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Trio Healthcare Ltd

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 32a2cb06-94fc-4eb9-9d58-c619040bc81f 61 fields · synced 22 Oct 2026