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DeFix

by Li̇nacol Medi̇kal A.Ş. Türkiye EUDAMED

Ref DeFix SH60, DeFix SAM60, DeFix SAM20, DeFix SAM40 EMDN P900403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683955400440 Basic UDI-DIDate18 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterile Bone Cement Vertebroplasty-60gr
Sterile Antibiotic Bone Cement Standard-60gr
DeFix Steril Antibiyotikli Kemik Çimentosu Standart 20 gr / DeFix Sterile Antibiotics Bone Cement Standart 20 gr
Steril Antibiyotikli Kemik Çimentosu Standart-40gr / Sterile Antibiotic Bone Cement Standard-40gr
Model / Reference
DeFix SH60, DeFix SAM60, DeFix SAM20, DeFix SAM40
Primary DI / UDI-DI
08683955400440, 08683955400419, 08681657508679, 08681657508778
Basic UDI-DI
B-08683955400440, B-08683955400419, B-08681657508679, B-08681657508778
EMDN Code
P900403 Non-resorbable filling and reconstruction devices
Device Class
Class IIb
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000033766

Other devices from Li̇nacol Medi̇kal A.Ş.

See all devices from Li̇nacol Medi̇kal A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (4)

  • EUDAMED 2524b021-ed00-4e8e-9dca-2dfb02900a04 61 fields · synced 22 Oct 2026
  • EUDAMED 08683955400419|B-08683955400419 61 fields · synced 17 May 2026
  • EUDAMED 08681657508679|B-08681657508679 61 fields · synced 17 May 2026
  • EUDAMED 08681657508778|B-08681657508778 61 fields · synced 19 May 2026