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Alpha-amylase (EPS)

by Clinichem Ltd. Hungary EUDAMED

Ref 47493

EMDN W01010107

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-47493MF000041060K3 Basic UDI-DIDate15 Oct 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 25 Oct 2026

Model / Reference
47493
Primary DI / UDI-DI
D-47493MF000041060K3
Basic UDI-DI
B-47493MF000041060K3
EMDN Code
W01010107 Amylase - total
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000041060

Other devices from Clinichem Ltd.

See all devices from Clinichem Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-47493MF000041060K3|B-47493MF000041060K3 61 fields · synced 25 Oct 2026