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ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST

by InTec PRODUCTS, INC. 2 variants

Ref ITP03004-DS50Model ITP03004

Active European Union

CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936155804535 Basic UDI-DI 06936155804535UDI-DIDate2 Apr 2024RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
ITP03004, ITP03004-DS50
Primary DI / UDI-DI
06936155804535
Basic UDI-DI
B-06936155804535
EMDN Code
W0105090105 Syphilis - rt & poc
Device Class
Class IVD General
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000023625
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from InTec PRODUCTS, INC.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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