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AQVITOX-D roztok 5000 ml, bandaska

by Aqvitox Technology, s.r.o.

Ref 5000ml bandaska

Active European Union

CE MDR

Valid until

20 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8588007405AQVITOXDROZTFW Basic UDI-DI 08588007405605UDI-DIDate29 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-012/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    16 Jul 2025
    Expires
    20 Mar 2029
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Aqvitox - D roztok
Model / Reference
5000ml bandaska
Primary DI / UDI-DI
08588007405605
Basic UDI-DI
8588007405AQVITOXDROZTFW
Direct Marketing DI
08588007405605
EMDN Code
M04041503 Dressings in solutions, emulsions, gels, powders with synthetic components
Device Class
Class IIb
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000026312

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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