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KET Rapid Test Kit (Colloidal gold method)

by Nanjing Synthgene Medical Technology Co., Ltd. China EUDAMED

Ref DP004

EMDN W0102090199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473302401 Basic UDI-DIDate1 Sep 2022RegisteredStatusActive

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

Model / Reference
DP004
Primary DI / UDI-DI
06974473302401
Basic UDI-DI
B-06974473302401
EMDN Code
W0102090199 Drugs of abuse - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023810
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanjing Synthgene Medical Technology Co., Ltd.

See all devices from Nanjing Synthgene Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c3b82554-ee4e-45da-ad9d-1c9b3458fcd8 61 fields · synced 22 Oct 2026