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Alzheimer' s Disease Rapid Test Kit

by AILEX(Hunan)Medical Equipment Co., Ltd. 3 variants

Ref LYHN-MY-ZC-03091Model Cassette: 1 piece

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975531323345 Basic UDI-DI 06975531323345UDI-DIDate17 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)
Model / Reference
Cassette: 1 piece, LYHN-MY-ZC-03091
Primary DI / UDI-DI
06975531323345
Basic UDI-DI
B-06975531323345
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000043377
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from AILEX(Hunan)Medical Equipment Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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