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Ultina INDIVIDUAL ONE

by Ultina s.r.o.

Ref iONEModel Ultina INDIVIDUAL

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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 NumberB-08594211180016 Basic UDI-DI 08594211180016UDI-DIDate13 Jun 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08594211180016 Basic UDI-DI 08594211180016UDI-DIDate13 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Ultina INDIVIDUAL
Model / Reference
iONE, Ultina INDIVIDUAL
Primary DI / UDI-DI
08594211180016
Basic UDI-DI
B-08594211180016, 859421118UltinaHM
EMDN Code
Y122103 Push wheelchairs
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000054978

Other devices from Ultina s.r.o.

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