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Complement C3 Assay Reagent Kit (Immunoturbidimetric)

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

Ref R07013Model R1: 20mL×3, R2: 20mL×1; 1×1mL EMDN W0102010203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R07013ZW Basic UDI-DIDate16 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Complement C3 Assay Reagent Kit (Immunoturbidimetric)
Model / Reference
R1: 20mL×3, R2: 20mL×1, 1×1mL, R07013
Primary DI / UDI-DI
D-R07013ZW
Basic UDI-DI
B-R07013ZW
EMDN Code
W0102010203 Complement component c3/c3c
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 & 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 2d16a8c8-5681-459e-adff-ee1677698d18 61 fields · synced 25 Oct 2026