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Bgi

by Bgi Europe a/S Denmark EUDAMED

Ref MFG030062Model 48 tests/kit

EMDN W0102080399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MFG030062QU Basic UDI-DIDate11 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
ALC-MS/MS Kit for the quantitative measurement of antibiotics in serum
Model / Reference
48 tests/kit, MFG030062
Primary DI / UDI-DI
D-MFG030062QU
Basic UDI-DI
B-MFG030062QU
EMDN Code
W0102080399 Antibiotics tdm - other
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

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 97af5613-1c4f-4f25-ba62-7509cc69f627 61 fields · synced 23 Oct 2026