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Hemodialysis Bicarbonate

by Vital Healthcare Sdn. Bhd. Malaysia EUDAMED

Ref HB009

EMDN F040201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09551019768210 Basic UDI-DIDate13 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 23 Oct 2026

Model / Reference
HB009
Primary DI / UDI-DI
09551019768210
Basic UDI-DI
B-09551019768210
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 (1)

  • EUDAMED 2f4c0620-d9ec-4c11-b5d3-c299d3ada2ce 61 fields · synced 23 Oct 2026