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Aysam

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

Active European Union

Ref A600 11 100 0142Model A600 11 100 0003

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08698823317119 Basic UDI-DIDate12 Sep 2024RegisteredStatusActive
European UnionCE/MDD NumberB-08698823317119 Basic UDI-DIDate12 Sep 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  • Withdrawn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

Device Name
Ayfix Di̇nami̇k Aksi̇yel Hari̇ci̇ Fixator Kare Klemp Femur-Tibia Kisa (Ayfix Dynamic Axial External Fixator with Square Clamp for Femur- Tibia Short)
Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
Model / Reference
A600 11 100 0142, A600 11 100 0003
Primary DI / UDI-DI
08698823317119
Basic UDI-DI
B-08698823317119, 8698823AFIX00001CH
Direct Marketing DI
08698823317119
EMDN Code
P09120499 External bone fixation systems - other
Device Class
Class IIb
Class I
Market of Registration
Türkiye
Belgium

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

Show 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