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Sonica

by SOLTEC S.r.l. Italy EUDAMED

Ref 4300 EP S4 SC V2 EMDN Z12011302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805108418FT002ST2M Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ultrasonic Cleaner
Model / Reference
4300 EP S4 SC V2
Primary DI / UDI-DI
08051084182214
Basic UDI-DI
805108418FT002ST2M
EMDN Code
Z12011302 Ultrasonic cleaning equipment
Device Class
Class I
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
IT-MF-000018179

Other devices from SOLTEC S.r.l.

See all devices from SOLTEC S.r.l. →

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 325e38bb-2c9a-4467-9f5f-9fa1123d2fce 61 fields · synced 24 Oct 2026