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Procise Stool Collection Kit for Laboratory Use

by Biosynex France EUDAMED

Ref 5453_Model Procise Stool Collection Kit EMDN W05019001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00185N8T Basic UDI-DIDate27 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  • Withdrawn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 22 Oct 2026

Device Name
Procise Stool Collection Kit
Model / Reference
Procise Stool Collection Kit, 5453_
Primary DI / UDI-DI
03532670103530
Basic UDI-DI
353267F00185N8T
EMDN Code
W05019001 Faeces collection devices
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 50e07929-e377-461c-bc2d-f90721fb1a82 61 fields · synced 22 Oct 2026