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Unium

by Synthes GmbH Switzerland EUDAMED

Ref 05.001.611

EMDN Z12130501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00734K4 Basic UDI-DIDate30 Jul 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
UNIUM Reciprocating Saw Handpiece
Model / Reference
05.001.611
Primary DI / UDI-DI
07611819655416
Basic UDI-DI
7611819a00734K4
Direct Marketing DI
07611819655416
EMDN Code
Z12130501 Motorised orthopaedic surgery systems
Device Class
Class IIa
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
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 79b692ab-a92c-4081-94a9-d71483103b67 61 fields · synced 24 Oct 2026