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APIX ControlSet

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH Austria EUDAMED

Ref 09925180190

EMDN W0103020702

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-09120036864436 Basic UDI-DIDate22 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-09120036864436 Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
09925180190
Primary DI / UDI-DI
09120036864436
Basic UDI-DI
B-09120036864436, 912003686TCM100000025C
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class IVD General
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000024115

Other devices from Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

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Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 09120036864436|B-09120036864436 61 fields · synced 25 Oct 2026
  • EUDAMED 09120036864436|912003686TCM100000025C 61 fields · synced 25 Oct 2026