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Ketamine test Kit ( Colloidal Gold )

by Sanqi Biomedical(Shandong)Co., Ltd. China EUDAMED

Ref 5078Model 3Q-FA1000

EMDN W0102090114

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697447273003MD Basic UDI-DIDate3 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
3Q-FA1000, 5078
Primary DI / UDI-DI
06974472730038
Basic UDI-DI
697447273003MD
EMDN Code
W0102090114 Phencyclidine
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000030641
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Sanqi Biomedical(Shandong)Co., Ltd.

See all devices from Sanqi Biomedical(Shandong)Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED c6063a6c-294a-4021-bfd3-3a4844599f40 61 fields · synced 22 Oct 2026