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zanadio

by Sidekick Health Germany GmbH

Ref zanadio 1.3.xModel zanadio version 1.3.x

Active European Union

CE MDR

Valid until

9 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Scarlet NB B.V.

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 NumberSCAR-24.2.1.1 Date24 Aug 2026IssuedStatusActive expires 9 Mar 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-24.2.1.1 Active Amended

    Quality management system EU MDR

    Certifier
    Scarlet NB B.V. 3022
    Issued
    24 Aug 2026
    Expires
    9 Mar 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
zanadio version 1.3.x, zanadio 1.3.x
Primary DI / UDI-DI
014260725520108
Basic UDI-DI
426072552zanadioMDR2MD
Direct Marketing DI
014260725520108
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005729

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