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Singclean®

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

Ref NGAL-03-1tModel Midstream: 1 test/box

EMDN W0102060207

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936020110297 Basic UDI-DIDate31 Dec 2025RegisteredStatusActive

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

Device Name
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test Kit (Colloidal Gold)
Model / Reference
Midstream: 1 test/box, NGAL-03-1t
Primary DI / UDI-DI
06936020110297
Basic UDI-DI
B-06936020110297
EMDN Code
W0102060207 Neutrophil gelatinase associated lipocalin (lipocalin 2)
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 a35e0ea9-abd5-483f-84dd-ebb3323eba60 61 fields · synced 22 Oct 2026