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SP-Buffer

by Sysmex Europe SE Germany EUDAMED

Ref 370-0030-4

EMDN W01030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426015434SP-BufferNM Basic UDI-DIDate31 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SP-Buffer
Model / Reference
370-0030-4
Primary DI / UDI-DI
04260154340247
Basic UDI-DI
426015434SP-BufferNM
EMDN Code
W01030199 Haematology reagents - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000022332

Other devices from Sysmex Europe SE

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b9e0affd-a0ec-4ed3-b5fa-2bafbc307138 61 fields · synced 22 Oct 2026