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GR01 β-Thalassemia Elution Buffer No. 2

by Tosoh Corporation EUDAMED

Active European Union

Ref 0024765

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number45601892100030267Q Basic UDI-DIDate5 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR 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
GR01 β-Thalassemia Elution Buffer
Model / Reference
0024765
Primary DI / UDI-DI
14562185406112
Basic UDI-DI
45601892100030267Q
EMDN Code
W0103010202 Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)
Device Class
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
JP-MF-000024143
Authorised representative
Tosoh Europe N.V. BE-AR-000000211

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Properties

  • 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