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Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)

by Yhlo Biotech (Nanjing) Co., Ltd. China EUDAMED

Ref 63H50TSC

EMDN W0102039018

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-63H50TSCTE Basic UDI-DIDate26 Nov 2025RegisteredStatusActive

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

Model / Reference
63H50TSC
Primary DI / UDI-DI
D-63H50TSCTE
Basic UDI-DI
B-63H50TSCTE
EMDN Code
W0102039018 Alpha-fucosidase
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050474
Authorised representative
Medunion S.L. ES-AR-000019366

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 8cd7ad75-9b1b-4099-98dd-8a306bedd6f1 61 fields · synced 23 Oct 2026