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RevDx Test Chip

by EFA Engineering for All Ltd EUDAMED

Active European Union

Ref T_FP01_aaba / 431-01011-31Model A

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07290020754011 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Rev Dx Test Chip
Model / Reference
A, T_FP01_aaba / 431-01011-31
Primary DI / UDI-DI
07290020754011
Basic UDI-DI
B-07290020754011
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IL-MF-000058180
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from EFA Engineering for All Ltd

  • RevDx

    IVD General

Properties

  • Near-Patient Testing
  • Professional Testing

Other properties (8)

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