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HemeScreen®

by Precipio Inc 9 variants

Ref HS-1P-AMLModel HemeScreen AML

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-USMF000053461HS1PAMLKK Basic UDI-DI D-USMF000053461HS1PAMLKKUDI-DIDate22 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
HemeScreen AML
Model / Reference
HemeScreen AML, HS-1P-AML
Primary DI / UDI-DI
D-USMF000053461HS1PAMLKK
Basic UDI-DI
B-USMF000053461HS1PAMLKK
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000053461
Authorised representative
Easy Medical Device CommV BE-AR-000011902

Other devices from Precipio Inc

See all devices from Precipio Inc →

Properties

  • Sterile
  • Reagent
  • Professional Testing

Other properties (7)

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