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by Zdravotní ústav se sídlem v Ostravě EUDAMED

Active European Union

Ref 007

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08594224840068TD Basic UDI-DIDate24 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
007
Primary DI / UDI-DI
08594224840068
Direct Marketing DI
08594224840068
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000046342

Other devices from Zdravotní ústav se sídlem v Ostravě

  • SA

    Class A

  • Nacl

    Class A

  • ENT

    Class A

  • Wchs

    Class A

  • Wch

    Class A

  • Ča

    Class A

See all devices from Zdravotní ústav se sídlem v Ostravě →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b5d300c6-f228-4eb7-afee-f540abfd2ba1 61 fields · synced 22 Oct 2026