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EMS3601

by EMS Physio ltd United Kingdom EUDAMED

Ref EMS3601Model Primo Ultrasound & Electrical Simulation, Primo 1MHz ultrasound EMDN Z120601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number506030097EMS8600Y7 Basic UDI-DIDate27 May 2026RegisteredStatusActive
European UnionCE/MDR Number506030097EMS8600Y7 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
Primo 1MHz ultrasound
Model / Reference
Primo Ultrasound & Electrical Simulation, EMS3601, Primo 1MHz ultrasound
Primary DI / UDI-DI
05060300970064
Basic UDI-DI
506030097EMS8600Y7, B-05060300970064
EMDN Code
Z120601 Electrotherapy equipment (included tens)
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 f4c6347d-9357-45f8-a539-0ff0dad0f664 61 fields · synced 24 Oct 2026
  • EUDAMED 05060300970064|B-05060300970064 61 fields · synced 19 Jun 2026