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PHASIFY™ ASCL1, LHX8 and SOX1 Genetic methylation PCR Test

by Phase Scientific International Limited

Ref PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-A069DK Basic UDI-DI D-A069DKUDI-DIDate14 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  • Withdrawn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
PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test
Model / Reference
PHASIFY™ ASCL1, LHX8 and SOX1 Genetic methylation PCR Test
Primary DI / UDI-DI
D-A069DK
Basic UDI-DI
B-A069DK
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
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