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BA 400 L / UNI Knee Immobilizer

by Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇. EUDAMED

Active European Union

Ref BA 400 LModel IMMOBILIZERS

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86824950IMMOBILIZERJU Basic UDI-DIDate15 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
BA 400 L / UNI Knee Immobilizer
BA 400 L / UNI Knee Immobilizer L
Device Name
Immobilizers
Model / Reference
IMMOBILIZERS, BA 400 L
Primary DI / UDI-DI
08682495004866, 08682495017989
Basic UDI-DI
86824950IMMOBILIZERJU
Direct Marketing DI
08682495004866
08682495017989
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000045383

Other devices from Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇.

See all devices from Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. 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