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Mag Gym

by Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike Slovenia EUDAMED

Ref MS019Model 31 Models from MDR Certificate 2023-MDR/QS-009/D

EMDN Z120606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2023-MDR/QS-009/D Date15 May 2026IssuedStatusActive expires 15 May 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-009/D Reissued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    15 May 2026
    Expires
    15 May 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Medical devices for Magneto Therapy
Model / Reference
31 Models from MDR Certificate 2023-MDR/QS-009/D, MS019
Primary DI / UDI-DI
03830066952084
Basic UDI-DI
383006695FMSJ5
Direct Marketing DI
03830066952084
EMDN Code
Z120606 Magnetotherapy equipment
Device Class
Class IIa
Market of Registration
Slovenia

Manufacturer details

EUDAMED SRN
SI-MF-000006345

Other devices from Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike

  • FMS Precision

    Class IIa
  • FMS Duo

    Class IIa
  • FMS Care

    Class IIa
  • FMS Former prestige

    Class IIa
  • FMS Stym

    Class IIa
  • FMS Uno

    Class IIa

See all devices from Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike →

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 (1)

  • EUDAMED 4f8ada25-79bc-47c3-bd90-bebfd61f9bb9 61 fields · synced 22 Oct 2026