Skip to content

Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Reagent Kit (Chemiluminescent Immunoassay)

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

Active European Union

Ref R22411Model 50 Tests/Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R2241124 Basic UDI-DIDate1 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  • Withdrawn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

Device Name
Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Reagent Kit (Chemiluminescent Immunoassay)
Model / Reference
50 Tests/Kit, R22411
Primary DI / UDI-DI
D-R2241124
Basic UDI-DI
B-R2241124
EMDN Code
W01021312 Lipoprotein-associated phospholipase a2
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

Other devices from Rayto Life and Analytical Sciences Co., Ltd.

See all devices from Rayto Life and Analytical Sciences Co., Ltd. →

Properties

Show 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