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N-terminal pro-Brain Natriuretic Peptide Rapid Test Kit (QDs Immunofluorescence Method)

by Chongqing iSIA BIO-Technology Co., Ltd. EUDAMED

Active European Union

Ref 01WModel AFS-1000, AFS-2000A, AFS-3000B, iSIA01, iSIA02, iSIA03, iSIA01A, iSIA01B, IFC-100, NT-proBNP-QD

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69749697901001DP Basic UDI-DIDate11 Jun 2025RegisteredStatusActive
European UnionCE/IVDR Number69749697901001DP Basic UDI-DIDate11 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
The Immunoassay Analyzer
Model / Reference
AFS-1000, AFS-2000A, AFS-3000B, iSIA01, iSIA02, iSIA03, iSIA01A, iSIA01B, IFC-100, 01W, NT-proBNP-QD
Primary DI / UDI-DI
26974969792147
Basic UDI-DI
69749697901001DP, B-26974969792147
EMDN Code
W0102160704, W01021301
Device Class
Class C
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003364
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Show properties
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No