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SAMPLING.pro - Stool Sample Collection & Stabilisation Kit

by BIOMES 4.0 GmbH EUDAMED

Active European Union

Ref REF4620Model FAECES

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426058294FAECES6B Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
FAECES, REF4620
Primary DI / UDI-DI
04260582940101
Basic UDI-DI
426058294FAECES6B
Direct Marketing DI
04260582940101
EMDN Code
W05019001 Faeces collection devices
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000052245

Other devices from BIOMES 4.0 GmbH

Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No