Skip to content

BA 400P XS / Pediatric Knee Immobilizer

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

Ref BA 400P XSModel IMMOBILIZERS

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86824950IMMOBILIZERJU Basic UDI-DI 08682495004903UDI-DIDate15 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  • Withdrawn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
Immobilizers
Model / Reference
IMMOBILIZERS, BA 400P XS
Primary DI / UDI-DI
08682495004903
Basic UDI-DI
86824950IMMOBILIZERJU
Direct Marketing DI
08682495004903
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
EU 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