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EMS560

by EMS Physio ltd United Kingdom EUDAMED

Ref EMS560Model Primo radial shockwave device , Primo radial shockwave

EMDN Z12139001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number506030097EMS5600XJ Basic UDI-DIDate27 May 2026RegisteredStatusActive
European UnionCE/MDR Number506030097EMS5600XJ Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Primo Radial Shockwave Device
Model / Reference
Primo radial shockwave device, EMS560, Primo radial shockwave
Primary DI / UDI-DI
05060300970606
Basic UDI-DI
506030097EMS5600XJ, B-05060300970606
EMDN Code
Z12139001 Shock wave therapy equipment
Device Class
Class IIb
Market of Registration
Malta

Manufacturer details

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

Other devices from Ems Physio Ltd.

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 (2)

  • EUDAMED b3662af4-0abd-4a6c-b3de-4fbe45b14753 61 fields · synced 22 Oct 2026
  • EUDAMED 05060300970606|B-05060300970606 61 fields · synced 9 Jul 2026