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Evita Test Complete

by ARCEDI Biotech ApS Denmark EUDAMED

Ref COM

EMDN V0599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G194EVITATESTQJ Basic UDI-DIDate22 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
EVITA TEST COMPLETE Blood collection kit
Model / Reference
COM
Primary DI / UDI-DI
G194COM0
Basic UDI-DI
++G194EVITATESTQJ
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class IIa
Medical Purpose
Collection, preservation, and transport of maternal blood samples.

Manufacturer details

EUDAMED SRN
DK-PR-000033007

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 784cd906-e3f9-4506-868e-b243569bb10e 61 fields · synced 22 Oct 2026