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VEUPLEX™ TBI assay

by EzDiaTech, Inc. EUDAMED

Active European Union

Ref EZ-TBIV

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809901510067 Basic UDI-DIDate16 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
EZ-TBIV
Primary DI / UDI-DI
08809901510067
Basic UDI-DI
B-08809901510067
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000026926
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from EzDiaTech, Inc.

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No