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Singclean

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

Ref EDDP-02-25tModel Cassette: 25 test/box

EMDN W0102090120

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-EDDP-02-25tB6 Basic UDI-DIDate19 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Methadone Metabolite (EDDP) One Step Test Kit (Colloidal Gold Method)
Model / Reference
Cassette: 25 test/box, EDDP-02-25t
Primary DI / UDI-DI
D-EDDP-02-25tB6
Basic UDI-DI
B-EDDP-02-25tB6
EMDN Code
W0102090120 Eddp specific (methadone metabolites)
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 4c79ed40-77a0-4be9-92dc-337130234455 61 fields · synced 22 Oct 2026