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Cndh

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

Ref HG-AMP-a08;HG-AMP-a07

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-HG-AMPA4 Basic UDI-DI D-HG-AMPA4UDI-DIDate7 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
One Step Amphetamine (AMP) Test Kit(Hair) (Colloidal Gold )
Model / Reference
HG-AMP-a08, HG-AMP-a07
Primary DI / UDI-DI
D-HG-AMPA4
Basic UDI-DI
B-HG-AMPA4
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

  • Human Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics

Other properties (4)

  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Surgical Instrument: No