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Haemodialysis Bicarbonate Bag

by Surni Labs EUDAMED

Active European Union

Ref SL2-HBB-555

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890618341SLHC00BPBDM Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Sodium Bicarbonate I.P./E.P./USP
Model / Reference
SL2-HBB-555
Primary DI / UDI-DI
08906183411959
Basic UDI-DI
890618341SLHC00BPBDM
EMDN Code
F040201 Dialysis concentrates, basic solutions, powder
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
IN-MF-000041295
Authorised representative
OMC NI MEDICAL LIMITED XI-AR-000019483

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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