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Simple Crypto-Giardia-Entamoeba

by Operon, S.A. EUDAMED

Active European Union

Ref 9.144.020.71.000Model 9.144.XXX.YY.ZZZ

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8429577914420D8 Basic UDI-DIDate22 Dec 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Simple Crypto-Giardia-Entamoeba 4R
Model / Reference
9.144.XXX.YY.ZZZ, 9.144.020.71.000
Primary DI / UDI-DI
08429577004907
Basic UDI-DI
8429577914420D8
EMDN Code
W0105090499 Parasites - rt & poc - other
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

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See all devices from Operon, S.A. →

Properties

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