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Singclean®

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

Ref IVD83-02-10tModel 10 tests/box

EMDN W0102160701

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IVD83-02-10tDC 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
Creatine Kinase Isoenzyme MB (CK-MB) Test Kit (Fluorescence Immunochromatography)
Model / Reference
10 tests/box, IVD83-02-10t
Primary DI / UDI-DI
D-IVD83-02-10tDC
Basic UDI-DI
B-IVD83-02-10tDC
EMDN Code
W0102160701 Creatine kinase - mb mass - rt & poc
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 509797f8-713d-4e69-863d-223851b7f275 61 fields · synced 22 Oct 2026