Skip to content

Immunoglobulin A (IgA) Assay Reagent Kit (Immunoturbidimetric)

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

Ref R06713Model R1:30mL×1 R2:10mL×1；1mL×1, R1: 20mL×3, R2: 20mL×1; 1×1mL

EMDN W0102010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R067122T Basic UDI-DIDate11 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 23 Oct 2026

Device Name
Immunoglobulin A (IgA) Assay Reagent Kit (Immunoturbidimetric)
Model / Reference
R1:30mL×1 R2:10mL×1；1mL×1, R06713, R1: 20mL×3, R2: 20mL×1, 1×1mL
Primary DI / UDI-DI
D-R067122T, D-R067132V
Basic UDI-DI
B-R067122T, B-R067132V
EMDN Code
W0102010101 Immunoglobulin a
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 (2)

  • EUDAMED d17f563d-5c4c-41c5-b4e1-6cc601b43faf 61 fields · synced 23 Oct 2026
  • EUDAMED D-R067132V|B-R067132V 61 fields · synced 23 Oct 2026