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Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)

by Dirui Industrial Co., Ltd 27 variants

Ref 3019846Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06925794577009 Basic UDI-DI 06925794577009UDI-DIDate13 May 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  • Withdrawn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

Model / Reference
R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL, 3019846
Primary DI / UDI-DI
06925794577009
Basic UDI-DI
B-06925794577009
EMDN Code
W01021312 Lipoprotein-associated phospholipase a2
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No