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β2-microglobulin Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)

by Rayto Life and Analytical Sciences Co., Ltd. EUDAMED

Active European Union

Ref R05812Model R1:40mL×1 R2:10mL×1；1mL×1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R058122R Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
β2-microglobulin Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)
Model / Reference
R1:40mL×1 R2:10mL×1；1mL×1, R05812
Primary DI / UDI-DI
D-R058122R
Basic UDI-DI
B-R058122R
EMDN Code
W0102039002 Beta2-microglobulin
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No