Skip to content

Duplicα RealTime Mix & Match Factor V G1691A Kit QS

by Clonit srl

Ref EER038032QSModel EER038032

Active European Union

CE IVDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805768091FVG1691_M01CH Basic UDI-DI 08057680910497UDI-DIDate8 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Duplica Real Time Mix & Match FACTOR V G1691A Kit
Model / Reference
EER038032, EER038032QS
Primary DI / UDI-DI
08057680910497
Basic UDI-DI
805768091FVG1691_M01CH
EMDN Code
W0106010103 Factor v leiden
Device Class
Class C
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022196

Other devices from Clonit srl

See all devices from Clonit srl →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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