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Revohem™ FIX chromogenic

by HYPHEN BioMed EUDAMED

Active European Union

Ref BP549402Model Factor IX (FIX) chromogenic

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number366353700056BG Basic UDI-DIDate18 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Model / Reference
Factor IX (FIX) chromogenic, BP549402
Primary DI / UDI-DI
03663537085635
Basic UDI-DI
366353700056BG
EMDN Code
W0103020208 Coagulation factor ix
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002214

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No