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Captia™ Cytomegalovirus IgM kit

by Trinity Biotech USA EUDAMED

Active European Union

Ref 2325260

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850048690400 Basic UDI-DIDate25 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Captia™ Cytomegalovirus IgM, 96 test kit
Model / Reference
2325260
Primary DI / UDI-DI
00850048690400
Basic UDI-DI
B-00850048690400
EMDN Code
W0105040204 Cmv igm
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000037514
Authorised representative
TrinityBiotech IE-AR-000013889

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Properties

Show properties
  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No