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Interleukin-6 (IL-6) test kit (fluorescence immunochromatography)

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

Active European Union

Ref 5503Model 3Q-FA1000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697447273011MC Basic UDI-DIDate7 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
3Q-FA1000, 5503
Primary DI / UDI-DI
06974472730113, 06974472730175, 06974472730199, 06974472730168, 06974472730137, 06974472730144, 06974472730090, 06974472730151, 06974472730106, 06974472730120, 06974472730182
Basic UDI-DI
697447273011MC, 697447273017MQ, 697447273019MU, 697447273016MN, 697447273013MG, 697447273014MJ, 697447273009MR, 697447273015ML, 697447273010MA, 697447273012ME, 697447273018MS
EMDN Code
W01030609 Interleukin 6 (il-6)
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.

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Properties

Show properties
  • 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