Skip to content

Wkładki ortopedyczne iORTO ELEGANCE

by Zbigniew Frąckowiak Mazbit Przedsiębiorstwo 2 variants

Ref iORTO WOMAN (SLIM) IO65

Active European Union

CE MDR

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 Number59025742IORTO-ELEGANCE6V Basic UDI-DI 05902574202109UDI-DIDate26 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
iORTO WOMAN (SLIM) IO65
Primary DI / UDI-DI
05902574202109
Basic UDI-DI
59025742IORTO-ELEGANCE6V
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039173

Other devices from Zbigniew Frąckowiak Mazbit Przedsiębiorstwo

See all devices from Zbigniew Frąckowiak Mazbit Przedsiębiorstwo →

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