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VEUDx

by EzDiaTech, Inc. EUDAMED

Active European Union

Ref V1-01A-2-1PModel V1-01A-2

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880990151V1-01A5H Basic UDI-DIDate17 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
V1-01A-2, V1-01A-2-1P
Primary DI / UDI-DI
08809901510005
Basic UDI-DI
880990151V1-01A5H
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Czechia

Manufacturer details

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

Other devices from EzDiaTech, Inc.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No