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Elite

by Medixdent International EUDAMED

Active European Union

Ref ED-025-151

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G359AmalgamCarversKE Basic UDI-DIDate16 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Amalgam Carvers
Model / Reference
ED-025-151
Primary DI / UDI-DI
+G359ED0251510T
Direct Marketing DI
+G359ED0251510T
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
PK-MF-000027173
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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