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Aysam

by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi 1,000+ variants

Ref A6111945070

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 11 Nov 2026. What this means

Regulatory status

as of registry sync 11 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08684543841768 Basic UDI-DI 08684543841768UDI-DIDate11 Apr 2024RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Korteks Dusuk Profil Vida Celik (Cortex Low Profil Screw Ss) 4,5 Mm X 70 Mm
Model / reference
A6111945070
Primary DI / UDI-DI
08684543841768
Basic UDI-DI
B-08684543841768
EMDN code
P09120601 Cortical screws
Device class
Class IIb
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017437

Overview

AI-generated summary, 11 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AYSAM is a cortex low profil screw SS.

It is listed under the EU MDD (superseded directive) registration as a Class IIb device with nomenclature code P09120601.

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Properties

  • Sterilise before use
  • Implantable

Other properties (10)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No