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Orthopaedic Gouges

by Synthes GmbH Switzerland EUDAMED

Ref 397.850Model Orthopaedic Gouges

EMDN L091001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00072J9 Basic UDI-DIDate6 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Orthopaedic Gouges
Model / Reference
Orthopaedic Gouges, 397.850
Primary DI / UDI-DI
07611819026933
Basic UDI-DI
7611819a00072J9
Direct Marketing DI
07611819026933
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
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

See all devices from Synthes GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • CMR Substance
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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 3176ea8a-6d93-4462-8001-f4a0b8a914e1 61 fields · synced 24 Oct 2026