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Multi-drug Urine Test Cup

by Assure Tech. (Hangzhou) Co., Ltd. EUDAMED

Active European Union

Ref MD-U610-AMP/MET/THC/MOP/COC/BZO/SOMA/PCP/MTD/MDMA

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16952804841161 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Multi-drug Urine Test Cup
Model / Reference
MD-U610-AMP/MET/THC/MOP/COC/BZO/SOMA/PCP/MTD/MDMA
Primary DI / UDI-DI
16952804841161
Basic UDI-DI
B-16952804841161
EMDN Code
W0102160511 Multiple drugs of abuse/toxicology rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002170
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Assure Tech. (Hangzhou) Co., Ltd.

See all devices from Assure Tech. (Hangzhou) Co., Ltd. →

Properties

Show properties
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No