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HSi Hemolysis & Wash Solution-(LL)

by Tosoh Europe N.V. Belgium EUDAMED

Ref 019550LModel HSi Hemolysis & Wash Solution-(LL) EMDN W01010214

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number543000049500019550LS4 Basic UDI-DIDate10 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HSi Hemolysis & Wash Solution-(LL), 019550L
Primary DI / UDI-DI
14562185380139
Basic UDI-DI
543000049500019550LS4
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000210

Other devices from Tosoh Europe N.V.

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 9749eddc-b86c-44aa-be0c-30d01f0c5e1a 61 fields · synced 22 Oct 2026