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biotical Calprotectin + Lactoferrin Card

by Biotical Health S.L.U EUDAMED

Active European Union

Ref RTB25CL, RTB25CLCModel biotical Calprotectin + Lactoferrin Card / 25 test rápidos con viales para muestra fecal (sin controles externos)., biotical Calprotectin + Lactoferrin Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Calprotectin + Lactoferrin)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942143942 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Trade Name
biotical Calprotectin + Lactoferrin Card
biotical Calprotectin + Lactoferrin Card (+PC)
Model / Reference
biotical Calprotectin + Lactoferrin Card / 25 test rápidos con viales para muestra fecal (sin controles externos)., RTB25CL, biotical Calprotectin + Lactoferrin Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Calprotectin + Lactoferrin), RTB25CLC
Primary DI / UDI-DI
84365942143942, 84365942144000
Basic UDI-DI
B-84365942143942, B-84365942144000
EMDN Code
W0102160199 Specific proteins rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000018831

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Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

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