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INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)

by Phase Scientific International Limited

Ref INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-A019D4 Basic UDI-DI D-A019D4UDI-DIDate10 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  • Withdrawn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

Model / Reference
INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)
Primary DI / UDI-DI
D-A019D4
Basic UDI-DI
B-A019D4
EMDN Code
W0105041002 Screening high-risk hpv - na reagents
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

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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