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Renasol

by Fresenius Medikal Tıbbi Cihaz ve Sarf Malzemeleri Üretim A.Ş. Türkiye EUDAMED

Ref RD.10.101Model Renasol BA-407 ACF

EMDN F040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683463794567 Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
RENASOL BA-407 ACF Acid Bicarbonate Concentrate Hemodialysis Solution 7 L
Model / Reference
Renasol BA-407 ACF, RD.10.101
Primary DI / UDI-DI
08683463794567
Basic UDI-DI
B-08683463794567
EMDN Code
F040101 Dialysis concentrates, acid solutions, non-sterile
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000025101

Other devices from Fresenius Medikal Tıbbi Cihaz ve Sarf Malzemeleri Üretim A.Ş.

See all devices from Fresenius Medikal Tıbbi Cihaz ve Sarf Malzemeleri Üretim A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • 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 (1)

  • EUDAMED f12b9cbc-e245-483a-8109-d020dafa80ff 61 fields · synced 22 Oct 2026