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Singclean®

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

Ref IL-6-02-100tModel 100 tests/box

EMDN W01030609

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IL-6-02-100tC2 Basic UDI-DIDate29 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
Interleukin-6 (IL-6) Test Kit (Fluorescence immunochromatography)
Model / Reference
100 tests/box, IL-6-02-100t
Primary DI / UDI-DI
D-IL-6-02-100tC2
Basic UDI-DI
B-IL-6-02-100tC2
EMDN Code
W01030609 Interleukin 6 (il-6)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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 b0f2a3dc-a7ee-49f2-b210-70a20ff9f547 61 fields · synced 22 Oct 2026