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Amphetamine(AMP) Rapid Test

by VivaChek Biotech (Hangzhou) Co., Ltd. China EUDAMED

Ref VDAM-101

EMDN W0102160501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-VDAM-101H9 Basic UDI-DIDate4 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
VDAM-101
Primary DI / UDI-DI
D-VDAM-101H9
Basic UDI-DI
B-VDAM-101H9
EMDN Code
W0102160501 Amphetamines - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from VivaChek Biotech (Hangzhou) Co., Ltd.

See all devices from VivaChek Biotech (Hangzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 8b0ed748-4531-445b-bb8c-5310c7d1eb6e 61 fields · synced 22 Oct 2026