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INDICAID™Dengue Virus Rapid NS1 Antigen Test

by Phase Scientific International Limited

Ref INDICAID™Dengue Virus Rapid NS1 Antigen Test

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-A006CT Basic UDI-DI D-A006CTUDI-DIDate9 Jul 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  • Withdrawn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

Device Name
INDICAID™Dengue Virus Rapid NS1 Antigen Test
Model / Reference
INDICAID™Dengue Virus Rapid NS1 Antigen Test
Primary DI / UDI-DI
D-A006CT
Basic UDI-DI
B-A006CT
EMDN Code
W0105099007 Dengue - rt & poc
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
HK-MF-000025791
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Phase Scientific International Limited

See all devices from Phase Scientific International Limited →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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