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Lp-PLA2 Test Kit (FIA)

by Guangdong Wesail Biotech Co., Ltd. China EUDAMED

Ref BA0280Model 20 tests/kit

EMDN W01021312

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973841000994 Basic UDI-DIDate28 May 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

Model / Reference
20 tests/kit, BA0280
Primary DI / UDI-DI
06973841000994
Basic UDI-DI
B-06973841000994
EMDN Code
W01021312 Lipoprotein-associated phospholipase a2
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000008828
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Guangdong Wesail Biotech Co., Ltd.

See all devices from Guangdong Wesail Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 767b7938-7cc9-4927-be05-530ab954002e 61 fields · synced 22 Oct 2026