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Aysam

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

Active European Union

Ref A600 10 050 0100Model A600 11 100 0003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8698823AFIX00001CH Basic UDI-DIDate27 Jan 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  • Withdrawn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

Device Name
Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
Yivli Cubuk (Threaded Rod) 100 Mm
Model / Reference
A600 11 100 0003, A600 10 050 0100
Primary DI / UDI-DI
08698823319182
Basic UDI-DI
8698823AFIX00001CH, B-08698823319182
Direct Marketing DI
08698823319182
EMDN Code
P09120499 External bone fixation systems - other
Device Class
Class I
Class IIb
Market of Registration
Cyprus
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017437

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

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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