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Serum amyloid A (SAA) test kit (fluorescence immunochromatography)

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

Active European Union

Ref 4769Model 3Q-FA1000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697447273005MH 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  • Withdrawn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, 4769
Primary DI / UDI-DI
06974472730052, 06974472730076, 06974472730069, 06974472730083
Basic UDI-DI
697447273005MH, 697447273007MM, 697447273006MK, 697447273008MP
EMDN Code
W0102019012 Amyloid beta-derived diffusible ligand (beta-amyloid oligomer)
Device Class
Class A
Market of Registration
France

Manufacturer details

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

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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