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Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 50tests/kit, 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit

EMDN W0102050212

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719601905 Basic UDI-DIDate25 May 2025RegisteredStatusActive

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
Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, 50tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, 100tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit
Primary DI / UDI-DI
06972719601905, 06972719605552, 06972719605545, 06972719602728, 06972719601899
Basic UDI-DI
B-06972719601905, B-06972719605552, B-06972719605545, B-06972719602728, B-06972719601899
EMDN Code
W0102050212 Soluble fms-like tyrosine kinase-1
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (5)

  • EUDAMED 26441bf4-b5f5-4851-b17d-fe5cd6106485 61 fields · synced 22 Oct 2026
  • EUDAMED 06972719605552|B-06972719605552 61 fields · synced 17 May 2026
  • EUDAMED 06972719605545|B-06972719605545 61 fields · synced 19 May 2026
  • EUDAMED 06972719602728|B-06972719602728 61 fields · synced 19 May 2026
  • EUDAMED 06972719601899|B-06972719601899 61 fields · synced 19 May 2026