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EasyScreen

by Genetic Signatures Ltd 14 variants

Ref PE001-MT Panel B

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09351179001260 Basic UDI-DI 09351179001260UDI-DIDate1 Nov 2024RegisteredStatusActive

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  • Withdrawn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
EasyScreen ® Pan Enteric Detection Kit PE001 Panel B
Model / Reference
PE001-MT Panel B
Primary DI / UDI-DI
09351179001260
Basic UDI-DI
B-09351179001260
EMDN Code
W0105070504 Gastrointestinal infections - multiplex na reagents
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000030901
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Genetic Signatures Limited

See all devices from Genetic Signatures Limited →

Properties

  • Reagent
  • Professional Testing
  • Surgical Instrument

Other properties (7)

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