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Apolipoprotein E (Apo E)Test Kit (Immunoturbidimetric Method)

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref "REF: USCA00000774, USCA00000778 USCA00000775 USCA00000737 USCA00000776 USCA00000738 USCA00000777 USCA00000739"

EMDN W0102010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6-130F9 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 24 Oct 2026

Device Name
Apolipoprotein E (Apo E)Test Kit (Immunoturbidimetric Method)
Model / Reference
"REF: USCA00000774, USCA00000778 USCA00000775 USCA00000737 USCA00000776 USCA00000738 USCA00000777 USCA00000739"
Primary DI / UDI-DI
D-6-130F9
Basic UDI-DI
B-6-130F9
EMDN Code
W0102010499 Lipoproteins - 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

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

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-6-130F9|B-6-130F9 61 fields · synced 24 Oct 2026