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Immunoglobulin M (IgM) Assay Reagent Kit (Immunoturbidimetric)

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

Ref R06816Model R1: 60mL×3, R2: 60mL×1; 1×1mL

EMDN W0102010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R0681638 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Immunoglobulin M (IgM) Assay Reagent Kit (Immunoturbidimetric)
Model / Reference
R1: 60mL×3, R2: 60mL×1, 1×1mL, R06816
Primary DI / UDI-DI
D-R0681638
Basic UDI-DI
B-R0681638
EMDN Code
W0102010107 Immunoglobulin m
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

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 9893dc5f-f6d0-49a0-966d-e43fdea1c8aa 61 fields · synced 22 Oct 2026