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ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test

by InTec PRODUCTS, INC. 3 variants

Ref ITP71002-TC40Model ITP71002

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-06936155803743 Basic UDI-DI 06936155803743UDI-DIDate25 May 2026RegisteredStatusActive

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  • Withdrawn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
ITP71002, ITP71002-TC40
Primary DI / UDI-DI
06936155803743
Basic UDI-DI
B-06936155803743
EMDN Code
W0105099007 Dengue - rt & poc
Device Class
Class IVD General
EU market of registration
Belgium

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
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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