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Hemodialysis Bicarbonate

by Vital Healthcare Sdn. Bhd. Malaysia EUDAMED

Ref HB001 EMDN F040201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555793102307 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Trade Name
Hemodialysis Bicarbonate
Sol-Cart® Bic Hemodialysis Bicarbonate
Model / Reference
HB001
Primary DI / UDI-DI
09555793102307, 09551032477922
Basic UDI-DI
B-09555793102307, B-09551032477922
EMDN Code
F040201 Dialysis concentrates, basic solutions, powder
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000005704
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Vital Healthcare Sdn. Bhd.

See all devices from Vital Healthcare Sdn. Bhd. →

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 (2)

  • EUDAMED 75b990d0-dd65-4551-9731-c777b6f8aeda 61 fields · synced 25 Oct 2026
  • EUDAMED 09551032477922|B-09551032477922 61 fields · synced 25 Oct 2026