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Hemodialysis Bicarbonate

by Vital Healthcare Sdn. Bhd. 4 variants

Ref HB002

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09551019761556 Basic UDI-DI 09551019761556UDI-DIDate13 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
HB002
Primary DI / UDI-DI
09551019761556
Basic UDI-DI
B-09551019761556
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

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