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Low Density Lipoprotein Cholesterol Assay Reagent Kit (Direct-Surfactant Clearance Method)

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

Ref R03412Model R1：40ml×3，R2：20ml×2 EMDN W01010221

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R03412ZL Basic UDI-DIDate20 Jul 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  • Withdrawn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 24 Oct 2026

Device Name
Low Density Lipoprotein Cholesterol Assay Reagent Kit (Direct-Surfactant Clearance Method)
Model / Reference
R1：40ml×3，R2：20ml×2, R03412
Primary DI / UDI-DI
D-R03412ZL
Basic UDI-DI
B-R03412ZL
EMDN Code
W01010221 Low density lipoprotein cholesterol including sd-ldl
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 D-R03412ZL|B-R03412ZL 61 fields · synced 24 Oct 2026