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

by Tody Laboratories Int. SRL

Ref C61RT1027

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594476025TESTERAPIDEUY Basic UDI-DI 05944760250037UDI-DIDate16 Mar 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Rapid Test Cassette
Model / Reference
C61RT1027
Primary DI / UDI-DI
05944760250037
Basic UDI-DI
594476025TESTERAPIDEUY
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class A
EU 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