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Renasol

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

Active European Union

Ref RD.10.071Model Renasol BA-403 C

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683463794383 Basic UDI-DIDate12 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  • Withdrawn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-403C Acid Bicarbonate Concentrate Hemodialysis Solution 7 L (1+44 C)
Model / Reference
Renasol BA-403 C, RD.10.071
Primary DI / UDI-DI
08683463794383
Basic UDI-DI
B-08683463794383
EMDN Code
F040101 Dialysis concentrates, acid solutions, non-sterile
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000025101

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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