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Borrelia All-In-One ViraChip IgG, IgM Antigen Coated Wells

by Viramed Biotech AG

Ref V-BTCFACModel Lyme Antibodies

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++EVIRLymeABCF Basic UDI-DI EVIRBTCFAC1UDI-DIDate15 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Lyme Antibodies, V-BTCFAC
Primary DI / UDI-DI
EVIRBTCFAC1
Basic UDI-DI
++EVIRLymeABCF
Direct Marketing DI
EVIRBTCFAC1
EMDN Code
W0105010602 Lyme antibody total
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000020368

Other devices from Viramed Biotech AG

See all devices from Viramed Biotech AG →

Properties

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

Other properties (6)

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