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Renasol

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

Active European Union

Ref RD.10.083Model Renasol BA 401 ACF

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683463794475 Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
RENASOL BA-401 ACF Acid Bicarbonate Concentrate Hemodialysis Solution 10L
Model / Reference
Renasol BA 401 ACF, RD.10.083
Primary DI / UDI-DI
08683463794475
Basic UDI-DI
B-08683463794475
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.

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Properties

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