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Aysam

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

Active European Union

Ref A601 11 099 0020Model A600 11 100 0003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08698823319878 Basic UDI-DIDate25 Jun 2024RegisteredStatusActive
European UnionCE/MDD NumberB-08698823319878 Basic UDI-DIDate25 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Pediyatrik Disi Yarim Mentese (Pediatric Female Half Hinge)
Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
Model / Reference
A601 11 099 0020, A600 11 100 0003
Primary DI / UDI-DI
08698823319878
Basic UDI-DI
B-08698823319878, 8698823AFIX00001CH
Direct Marketing DI
08698823319878
EMDN Code
P09120499 External bone fixation systems - other
Device Class
Class IIb
Class I
Market of Registration
Türkiye
Greece

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

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