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Fuller Laboratories by VMRD Anaplasma phagocytophilum IFA IgM Antibody Kit

by VMRD, Inc.

Ref EEM-120

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850078245090 Basic UDI-DI 00850078245090UDI-DIDate6 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Anaplasma phagocytophilum IFA IgM Antibody Kit
Model / Reference
EEM-120
Primary DI / UDI-DI
00850078245090
Basic UDI-DI
B-00850078245090
EMDN Code
W0105011799 Bacteriology immunoassay - other
Device Class
Class IVD General
EU market of registration
Czechia

Manufacturer details

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

Other devices from VMRD, Inc.

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No