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PLA2R IgG Antibody assay kit (Fluorescence Immunoassay)

by DiYaLab ZJG Biotech Co., Ltd 3 variants

Ref DL246302Model 50tests/kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975424225039 Basic UDI-DI 06975424225039UDI-DIDate26 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
PLA2R IgG Antibody assay kit (Fluorescence Immunoassay)
Model / Reference
50tests/kit, DL246302
Primary DI / UDI-DI
06975424225039
Basic UDI-DI
B-06975424225039
EMDN Code
W0102109099 Auto-immune disease tests - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048648
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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