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Fuller Laboratories by VMRD Babesia microti IFA Human IgM Antibody Kit

by VMRD, Inc. United States EUDAMED

Ref BMM-120

EMDN W0105050299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850078245045 Basic UDI-DIDate6 Nov 2025RegisteredStatusActive

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
Babesia microti IFA Human IgM Antibody Kit
Model / Reference
BMM-120
Primary DI / UDI-DI
00850078245045
Basic UDI-DI
B-00850078245045
EMDN Code
W0105050299 Parasitology - other
Device Class
Class IVD General
Market of Registration
Slovenia

Manufacturer details

EUDAMED SRN
US-MF-000049394
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Properties & raw data

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

Sources (1)

  • EUDAMED 811dc818-3ea2-404c-a8d0-948178e9b3fd 61 fields · synced 22 Oct 2026