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Phospholipid Reagent Kit (Choline Oxide Assay)

by Dirui Industrial Co., Ltd China EUDAMED

Ref 3021666Model R1: 1x40mL, R2: 1x10mL，Calibration sample:1x1mL, Control:1x1mL

EMDN W01010224

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06925794592798 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
R1: 1x40mL, R2: 1x10mL，Calibration sample:1x1mL, Control:1x1mL, 3021666
Primary DI / UDI-DI
06925794592798
Basic UDI-DI
B-06925794592798
EMDN Code
W01010224 Phospholipids
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties & raw data

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

Sources (1)

  • EUDAMED 552dfb8b-f6c8-495e-911d-365174ca4045 61 fields · synced 22 Oct 2026