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Primo dual frequency ultrasound

by EMS Physio ltd EUDAMED

Active European Union

Ref EMS460Model Primo dual frequency ultrasound, Primo Ultrasound & Electrical Simulation

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-05060300970002 Basic UDI-DIDate27 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-05060300970002 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Primo dual frequency ultrasound, EMS460, Primo Ultrasound & Electrical Simulation
Primary DI / UDI-DI
05060300970002
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000029343
Authorised representative
Advena Limited MT-AR-000000234

From the manufacturer

Manufacturer's product page: Primo Therasonic Multidyne

Other devices from EMS Physio ltd