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Bio-Intrafix

by DePuy Mitek United States EUDAMED

Ref 254629

EMDN P09120699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-USMF000045334000071TV Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

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 24 Oct 2026

Model / Reference
254629
Primary DI / UDI-DI
D-USMF000045334000071TV
Basic UDI-DI
B-USMF000045334000071TV
EMDN Code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000045334
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from DePuy Mitek, Inc.

See all devices from DePuy Mitek, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED D-USMF000045334000071TV|B-USMF000045334000071TV 61 fields · synced 24 Oct 2026