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Revohem™ FIX chromogenic

by HYPHEN BioMed 2 variants

Ref BD496632Model Factor IX (FIX) chromogenic

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number366353700056BG Basic UDI-DI 03663537082665UDI-DIDate18 Sep 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  • Withdrawn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

Model / Reference
Factor IX (FIX) chromogenic, BD496632
Primary DI / UDI-DI
03663537082665
Basic UDI-DI
366353700056BG
EMDN Code
W0103020208 Coagulation factor IX
Device Class
Class C
EU 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