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Fuller Laboratories by VMRD Orientia tsutsugamushi MIF IgM Antibody Kit

by VMRD, Inc. EUDAMED

Active European Union

Ref OTM-100

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850078245205 Basic UDI-DIDate11 Jun 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  • Withdrawn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
Orientia tsutsugamushi MIF IgM Antibody Kit
Model / Reference
OTM-100
Primary DI / UDI-DI
00850078245205
Basic UDI-DI
B-00850078245205
EMDN Code
W0105011799 Bacteriology immunoassay - other
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

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

Other devices from VMRD, Inc.

See all devices from VMRD, Inc. →

Properties

  • 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