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Neutrophil gelatinase-associated lipocalin (NGAL)Test Kit (Latex Immunoturbidimetric Method)

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref "REF: USCA00000722, USCA00000725 USCA00000723, USCA00000724 USCA00000726, USCA00000771"

EMDN W0102010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6-127FL Basic UDI-DIDate22 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

Device Name
Neutrophil gelatinase-associated lipocalin (NGAL)Test Kit (Latex Immunoturbidimetric Method)
Model / Reference
"REF: USCA00000722, USCA00000725 USCA00000723, USCA00000724 USCA00000726, USCA00000771"
Primary DI / UDI-DI
D-6-127FL
Basic UDI-DI
B-6-127FL
EMDN Code
W0102010399 Transport proteins - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-6-127FL|B-6-127FL 61 fields · synced 22 Oct 2026