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STA® - Quali-Clot II

by Diagnostica Stago France EUDAMED

Ref 00988 EMDN W0103020702

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3607450CTLG0006LZ Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
00988
Primary DI / UDI-DI
13607450009887
Basic UDI-DI
3607450CTLG0006LZ
Unit of Use DI
03607450009880
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000017089

Other devices from Diagnostica Stago

See all devices from Diagnostica Stago →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 13607450009887|3607450CTLG0006LZ 61 fields · synced 25 Oct 2026