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Farmakon a 4K 3AS G 5LT

by KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti. Türkiye EUDAMED

Ref 547

EMDN F040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8699459938761PX Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2616201 Issued

    Quality management system EU MDR

    Notified body
    Notified body 2975
    Issued
    11 Jun 2026
    Expires
    10 Jun 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Farmakon Acidic Concentrate Hemodialysis Solution
Model / Reference
547
Primary DI / UDI-DI
08699459935470
Basic UDI-DI
8699459938761PX
EMDN Code
F040101 Dialysis concentrates, acid solutions, non-sterile
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020885

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED f3a05a2f-3db7-4527-99ae-b3062f875737 61 fields · synced 24 Oct 2026