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BiomeCollect

by Biome Diagnostics GmbH Austria EUDAMED

Ref COLLECT-ULTModel BiomeCollect EMDN W05019001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number912014435COLLECTA9 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
BiomeCollect, COLLECT-ULT
Primary DI / UDI-DI
09120144350012
Basic UDI-DI
912014435COLLECTA9
Direct Marketing DI
09120144350012
EMDN Code
W05019001 Faeces collection devices
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000052920

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED f7f67fb4-4137-41c9-bafe-1f262d916e91 61 fields · synced 24 Oct 2026