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Standart Epi̇kondi̇li̇t Bandaji Std

by Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇. 2 variants

Ref DNB 5314

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 Number86978888BNDJ9A Basic UDI-DI 08697888894672UDI-DIDate21 Jul 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  • Withdrawn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
Bandaj
Model / Reference
DNB 5314
Primary DI / UDI-DI
08697888894672
Basic UDI-DI
86978888BNDJ9A
Direct Marketing DI
08697888894672
EMDN Code
Y060615 Elbow 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