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Hemolysis Collection System 10 µL

by Tosoh Europe N.V. Belgium EUDAMED

Ref 0968780Model Hemolysis Collection System 10 µL EMDN W0103010202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430000495000968780UC 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  • Withdrawn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
Hemolysis Collection System 10 µL, 0968780
Primary DI / UDI-DI
04562185380071
Basic UDI-DI
5430000495000968780UC
EMDN Code
W0103010202 Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)
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 fef966a5-1c63-4971-b3cb-ef10973d1b41 61 fields · synced 22 Oct 2026