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Ortopedické vložky pre priečne ploché nohy, multiform, dámske

by PROTETIKA, a.s. 4 variants

Ref 8585003407206Model Insoles

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number858500J29263PNMULTI37LH Basic UDI-DI 08585003407206UDI-DIDate22 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  • Withdrawn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
Insoles, 8585003407206
Primary DI / UDI-DI
08585003407206
Basic UDI-DI
858500J29263PNMULTI37LH
Direct Marketing DI
08585003407206
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000004489

Other devices from PROTETIKA, a.s.

See all devices from PROTETIKA, a.s. →

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