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Haemodialysis Bicarbonate Cartridge

by Surni Labs 6 variants

Ref SL2-HBC-650

Active European Union

CE MDR

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/MDR Number890618341SLHC00BPBDM Basic UDI-DI 08906183412154UDI-DIDate16 Jul 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Sodium Bicarbonate I.P./E.P./USP
Model / Reference
SL2-HBC-650
Primary DI / UDI-DI
08906183412154
Basic UDI-DI
890618341SLHC00BPBDM
EMDN Code
F040201 Dialysis concentrates, basic solutions, powder
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

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

Other devices from Surni Labs

See all devices from Surni Labs →

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