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Biofix

by Synergie Ingenierie Medicale France EUDAMED

Ref 881147

EMDN P090805

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03700448205773 Basic UDI-DIDate25 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Biofix Hip Spacer with gentamicin
Model / Reference
881147
Primary DI / UDI-DI
03700448205773
Basic UDI-DI
B-03700448205773
EMDN Code
P090805 Hip prostheses spacers
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001635

Other devices from Synergie Ingenierie Medicale

See all devices from Synergie Ingenierie Medicale →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Administering Medicine
  • Incorporates Medicinal Product
Other properties (7)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 42cf394e-b571-497b-ae4e-d4839769b0f6 61 fields · synced 22 Oct 2026