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spinit®

by biosurfit SA Portugal EUDAMED

Ref 140300Model spinit® BC

EMDN W0103010604

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-140300LX Basic UDI-DIDate8 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
spinit® BC
Model / Reference
spinit® BC, 140300
Primary DI / UDI-DI
D-140300LX
Basic UDI-DI
B-140300LX
EMDN Code
W0103010604 White blood cells (wbc)
Device Class
Class IVD General
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
PT-MF-000033920

Other devices from biosurfit SA

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 242c288d-a060-4fc4-a92b-76c6dacd9a44 61 fields · synced 22 Oct 2026