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Cndh

by Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd. China EUDAMED

Ref U-MCAT-a01；U-MCAT-a02；U-MCAT-a03；U-MCAT-b01；U-MCAT-b02；U-MCAT-b03 EMDN W0102160599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNMF000020377UMCATNU Basic UDI-DIDate30 Jun 2023RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
One Step Methcathinone (MCAT)Test Kit (Urine)(Colloidal Gold)
Model / Reference
U-MCAT-a01；U-MCAT-a02；U-MCAT-a03；U-MCAT-b01；U-MCAT-b02；U-MCAT-b03
Primary DI / UDI-DI
D-CNMF000020377UMCATNU
Basic UDI-DI
B-CNMF000020377UMCATNU
EMDN Code
W0102160599 Drugs of abuse/toxicology rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000020377
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd

See all devices from Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
Other properties (4)
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b43a8211-fc2d-4211-9574-89c441ffb6df 61 fields · synced 24 Oct 2026