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Bgi

by Bgi Europe a/S Denmark EUDAMED

Ref EU0100010050Model 50 tests/package

EMDN W0105040501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-EU0100010050DY Basic UDI-DIDate13 May 2022RegisteredStatusActive

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 23 Oct 2026

Device Name
Adenovirus nucleic acid detection and adenovirus 41 identification kit (fluorescent PCR method)
Model / Reference
50 tests/package, EU0100010050
Primary DI / UDI-DI
D-EU0100010050DY
Basic UDI-DI
B-EU0100010050DY
EMDN Code
W0105040501 Adenovirus - na reagents
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Properties & raw data

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

Sources (1)

  • EUDAMED 006e50c9-f4f7-4792-bb36-6a63d96c1a4e 61 fields · synced 23 Oct 2026