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Aysam

by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi Türkiye EUDAMED

Ref A601 13 200 0090Model A600 11 100 0003 EMDN P09120499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08698823318390 Basic UDI-DIDate20 Jun 2024RegisteredStatusActive
European UnionCE/MDD NumberB-08698823318390 Basic UDI-DIDate20 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Femur Kemer Karbon (Femur Arches Carbon ) 90º X 200 Mm
Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
Model / Reference
A601 13 200 0090, A600 11 100 0003
Primary DI / UDI-DI
08698823318390
Basic UDI-DI
B-08698823318390, 8698823AFIX00001CH
Direct Marketing DI
08698823318390
EMDN Code
P09120499 External bone fixation systems - other
Device Class
Class IIb
Class I
Market of Registration
Türkiye
Austria

Manufacturer details

EUDAMED SRN
TR-MF-000017437

Other devices from Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi

See all devices from Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 65aa0254-e042-4a82-8f20-26b89e1f654e 61 fields · synced 22 Oct 2026
  • EUDAMED 08698823318390|8698823AFIX00001CH 61 fields · synced 17 May 2026