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Cndh

by Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd. 40 variants

Ref U-KET-a01;U-KET-a02;U-KET-a03;U-KET-b01;U-KET-b02;U-KET-b03;U-KET-c01;U-KET-c02;U-KET-c03

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-U-KETZ9 Basic UDI-DI D-U-KETZ9UDI-DIDate30 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
One Step Ketamine (KET) Test Kit (Urine)(Colloidal Gold)
Model / Reference
U-KET-a01, U-KET-a02, U-KET-a03, U-KET-b01, U-KET-b02, U-KET-b03, U-KET-c01, U-KET-c02, U-KET-c03
Primary DI / UDI-DI
D-U-KETZ9
Basic UDI-DI
B-U-KETZ9
EMDN Code
W0102160599 Drugs of abuse/toxicology rt & poc - other
Device Class
Class IVD General
EU 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

  • 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