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Folate (Electrochemiluminescence Immunoassay)

by Shenzhen Lifotronic Technology Co., Ltd. EUDAMED

Active European Union

Ref 694020Model 2×50T, 50T，2×50T，100T，2×100T

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975984063195 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06975984063195 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
2×50T, 694020, 50T，2×50T，100T，2×100T
Primary DI / UDI-DI
06975984063195
Basic UDI-DI
B-06975984063195, 69703416803205021J3
EMDN Code
W0102070103 Folate
Device Class
Class IVD General
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005654
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No