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Ortopedická obuv pre diabetikov

by Diawin s.r.o. 336 variants

Ref AF17391Model Cloudy Orchid

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 Number858602288AF17FV Basic UDI-DI 08586022880100UDI-DIDate3 Sep 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Ortopedická obuv pre diabetikov
Model / Reference
Cloudy Orchid, AF17391
Primary DI / UDI-DI
08586022880100
Basic UDI-DI
858602288AF17FV
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000048596

Other devices from Diawin s.r.o.

See all devices from Diawin 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