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D-Dimer/FDP Test Kit (QDs-FICA)

by Chongqing Juce Life Health Technology Co., Ltd. China EUDAMED

Ref AD1001Model 1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box

EMDN W01010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977981880003 Basic UDI-DIDate19 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

Model / Reference
1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box, AD1001
Primary DI / UDI-DI
06977981880003
Basic UDI-DI
B-06977981880003
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000053774
Authorised representative
Share info GmbH DE-AR-000005132

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 30f16c89-8cd9-4ad2-abcd-04a3f5f1f23c 61 fields · synced 22 Oct 2026