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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED

Ref MDMA-05-25tModel Panel: 25 test/box

EMDN W0102090119

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MDMA-05-25tHH Basic UDI-DIDate14 May 2026RegisteredStatusActive

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 23 Oct 2026

Device Name
Methylenedioxymethamphetamine (MDMA) One Step Test Kit (Colloidal Gold Method)
Model / Reference
Panel: 25 test/box, MDMA-05-25t
Primary DI / UDI-DI
D-MDMA-05-25tHH
Basic UDI-DI
B-MDMA-05-25tHH
EMDN Code
W0102090119 Mdma (ecstasy)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9e1e2fc4-8b01-4694-ac09-b09072ed88b1 61 fields · synced 23 Oct 2026