Skip to content

Renasol

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

Ref RD.10.013Model Renasol BB-8.4

EMDN F040202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683463794000 Basic UDI-DIDate11 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 BB-8.4 Basic Bicarbonate Concentrate Hemodialysis Solution 6L
Model / Reference
Renasol BB-8.4, RD.10.013
Primary DI / UDI-DI
08683463794000
Basic UDI-DI
B-08683463794000
EMDN Code
F040202 Dialysis concentrates, basic solutions, liquid
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 7add7c20-afdd-49c5-9463-c433fc84aafe 61 fields · synced 22 Oct 2026