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Solhemo A - 871

by Sterima EUDAMED

Active European Union

Ref 30425000098

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5412977AconcentratePK Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE26/00000039 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    16 Feb 2026
    Expires
    16 Feb 2031

Specification

EUDAMED

Device Name
Liquid Acid Concentrate for bicarbonate based HD, HDF and HF
Model / Reference
30425000098
Primary DI / UDI-DI
05412977000252
Basic UDI-DI
5412977AconcentratePK
EMDN Code
F040101 Dialysis concentrates, acid solutions, non-sterile
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000017855

Other devices from Sterima

See all devices from Sterima →

Properties

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