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Neuron-Specific Enolase (NSE) Rapid Quantitative Test

by Xenta Biomedical Science Co., Ltd. EUDAMED

Active European Union

Ref XRDL043A105OS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975278861056 Basic UDI-DIDate8 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Neuron-Specific Enolase (NSE) Rapid Quantitative Test
Model / Reference
XRDL043A105OS
Primary DI / UDI-DI
06975278861056
Basic UDI-DI
B-06975278861056
EMDN Code
W0102039007 Neuron specific enolase
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000057746
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Xenta Biomedical Science Co., Ltd.

See all devices from Xenta Biomedical Science Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No