Skip to content

Cea Rapid Test Cassette (Whole Blood/Serum/Plasma)

by Tody Laboratories Int. SRL EUDAMED

Active European Union

Ref C61RT1028

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594476025TESTERAPIDEUY Basic UDI-DIDate16 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

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

Specification

EUDAMED

Device Name
Rapid Test Cassette
Model / Reference
C61RT1028
Primary DI / UDI-DI
05944760250068
Basic UDI-DI
594476025TESTERAPIDEUY
EMDN Code
W0102030112 Carcinoembryonic antigen
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000032726

Other devices from Tody Laboratories Int. SRL

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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