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Folate in vitro diagnostic kit (Chemiluminescent Immunoassay)

by Aikang Diagnostics Co., Ltd China EUDAMED

Ref AKBR3026030

EMDN W0102070103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-3026A6 Basic UDI-DIDate26 May 2026RegisteredStatusActive

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 23 Oct 2026

Device Name
Folate in vitro diagnostic kit (Chemiluminescent Immunoassay)
Model / Reference
AKBR3026030
Primary DI / UDI-DI
D-3026A6
Basic UDI-DI
B-3026A6
EMDN Code
W0102070103 Folate
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000028962
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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 de4ff460-7046-49a1-889c-12fb52e4ffee 61 fields · synced 23 Oct 2026