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WaveOne® Gold Reciprocating Files Sterile

by Maillefer Instruments Holding Sàrl EUDAMED

Active European Union

Ref A0751225G9D03Model WaveOne Gold (SU, NiTi, Ro, MSA)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J00310039E8 Basic UDI-DIDate28 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  • Withdrawn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
WaveOne® Gold
Model / Reference
WaveOne Gold (SU, NiTi, Ro, MSA), A0751225G9D03
Primary DI / UDI-DI
J003A0751225G9D031
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CH-MF-000016301
Authorised representative
Dentsply DeTrey GmbH DE-AR-000005904

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