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Singclean®

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

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

EMDN W0102090114

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-PCP-05-25tNA Basic UDI-DIDate19 Dec 2025RegisteredStatusActive
European UnionCE/IVDD NumberB-PCP-05-25tNA Basic UDI-DIDate19 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Phencyclidine (PCP) One Step Test Kit (Colloidal Gold Method)
Model / Reference
Panel: 25 test/box, PCP-05-25t
Primary DI / UDI-DI
D-PCP-05-25tNA
Basic UDI-DI
B-PCP-05-25tNA
EMDN Code
W0102090114 Phencyclidine
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 45c8732e-feb7-46ba-816d-fd551e673dbe 61 fields · synced 22 Oct 2026