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Tpha-Dat Advanced

by DIESSE Diagnostica Senese S.p.A Italy EUDAMED

Ref 26041Model TPHAD

EMDN W0105010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803389132TPHAD00ND Basic UDI-DIDate5 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
TPHAD, 26041
Primary DI / UDI-DI
08033891328429
Basic UDI-DI
803389132TPHAD00ND
EMDN Code
W0105010302 Syphilis antibody assays total
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000013311

Other devices from Diesse Diagnostica Senese S.P.A

See all devices from Diesse Diagnostica Senese S.P.A →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 8152f9c0-d61a-43c8-b58b-e46e69e91b49 61 fields · synced 22 Oct 2026