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Polikabon Ayakbileği Rotasyon Ortezi (FOOT GUARD) AFO(38- 41)

by Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇.

Ref AB 13(M)

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 Number86978888ABCATELAZ Basic UDI-DI 08697888835651UDI-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  • Withdrawn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

Device Name
Alçi Çeşi̇tleri̇
Model / Reference
AB 13(M)
Primary DI / UDI-DI
08697888835651
Basic UDI-DI
86978888ABCATELAZ
Direct Marketing DI
08697888835651
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000035839

Other devices from Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇. →

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