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Neuron Specific Enolase Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. EUDAMED

Active European Union

Ref 215790004Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719600700 Basic UDI-DIDate11 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Neuron Specific Enolase Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit, 215790004
Primary DI / UDI-DI
06972719600700
Basic UDI-DI
B-06972719600700
EMDN Code
W0102039007 Neuron specific enolase
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

  • 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