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FMS Care II

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

Active European Union

Ref MS028Model 31 Models from MDR Certificate 2023-MDR/QS-009/D

Regulatory status

as of 27 Oct 2026

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

Coverage

1 jurisdiction

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  • Withdrawn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

Device Name
Medical devices for Magneto Therapy
Model / Reference
31 Models from MDR Certificate 2023-MDR/QS-009/D, MS028
Primary DI / UDI-DI
03830066952176
Basic UDI-DI
383006695FMSJ5
Direct Marketing DI
03830066952176
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

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    Class IIa

  • FMS Precision

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  • FMS Duo

    Class IIa

  • FMS Care

    Class IIa

  • FMS Former prestige

    Class IIa

  • FMS Stym

    Class IIa

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

Properties

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