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StarFormer Applicator

by FOTONA, proizvodnja optoelektronskih naprav d.o.o. Slovenia EUDAMED

Ref Radial XLarge

EMDN Z120606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3830054230006SB Basic UDI-DIDate17 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2022-MDR/QS-021/A Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    26 Sep 2023
    Expires
    21 Sep 2027

Specification

EUDAMED · synced 24 Oct 2026

Device Name
StarFormer
Model / Reference
Radial XLarge
Primary DI / UDI-DI
03830054237094
Basic UDI-DI
3830054230006SB
EMDN Code
Z120606 Magnetotherapy equipment
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
SI-MF-000000126

Other devices from FOTONA, proizvodnja optoelektronskih naprav d.o.o.

See all devices from FOTONA, proizvodnja optoelektronskih naprav d.o.o. →

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 03830054237094|3830054230006SB 61 fields · synced 24 Oct 2026