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External orthopaedic fixation system component multiple use

by Synthes GmbH Switzerland EUDAMED

Ref 390.035Model External orthopaedic fixation system component multiple use

EMDN P0912040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00014HT Basic UDI-DIDate8 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
External orthopaedic fixation system component multiple use
Model / Reference
External orthopaedic fixation system component multiple use, 390.035
Primary DI / UDI-DI
07611819784192
Basic UDI-DI
7611819a00014HT
Direct Marketing DI
07611819784192
EMDN Code
P0912040102 Axial bone fixation systems
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

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Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • 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 f5852d3e-1fc9-44e1-9add-c251843390f4 61 fields · synced 23 Oct 2026