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Ozosmart LO0001B1

by ZAT a.s. Czechia EUDAMED

Ref Ozosmart LO0001B1 EMDN Z12040207

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859421014/Ozosmart/4F Basic UDI-DIDate27 May 2026RegisteredStatusActive

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  • Withdrawn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-015 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    31 Jul 2023
    Expires
    31 Jul 2028

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ozosmart - device for ozone therapy
Model / Reference
Ozosmart LO0001B1
Primary DI / UDI-DI
08594210140011
Basic UDI-DI
859421014/Ozosmart/4F
Direct Marketing DI
08594210140011
EMDN Code
Z12040207 Ozone therapy equipment
Device Class
Class IIb
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000006476

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 9ecbc451-fef0-4176-928c-379ba3f8e719 61 fields · synced 24 Oct 2026