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Human Assayed Control (Level 1)

by Fortress Diagnostics Ltd XI EUDAMED

Ref BXC0312E

EMDN W0101050101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060476975535 Basic UDI-DIDate7 Oct 2026RegisteredStatusActive

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 25 Oct 2026

Model / Reference
BXC0312E
Primary DI / UDI-DI
05060476975535
Basic UDI-DI
B-05060476975535
EMDN Code
W0101050101 Assayed multicomponent controls (cc)
Device Class
Class IVD General
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000028408

Other devices from Fortress Diagnostics Ltd

See all devices from Fortress Diagnostics Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED 05060476975535|B-05060476975535 61 fields · synced 25 Oct 2026