Skip to content

Biofix

by Synergie Ingenierie Medicale EUDAMED

Active European Union

Ref 881154

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03700448200679 Basic UDI-DIDate20 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Biofix Hip Spacer with gentamicin
Model / Reference
881154
Primary DI / UDI-DI
03700448200679
Basic UDI-DI
B-03700448200679
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

  • 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