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Amylase Fl

by Chema Diagnostica Srl

Ref AM F060 CH

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number803365084AMRR Basic UDI-DI 08033650840063UDI-DIDate9 Feb 2022RegisteredStatusActive
European UnionCE/IVDR Number803365084AMRR Basic UDI-DI 08033650840063UDI-DIDate9 Feb 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Model / Reference
AM F060 CH
Primary DI / UDI-DI
08033650840063
Basic UDI-DI
803365084AMRR, B-08033650840063
Direct Marketing DI
08033650840063
EMDN Code
W01010107 Amylase - total
Device Class
Class B
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009128

Other devices from Chema Diagnostica Srl

See all devices from Chema Diagnostica Srl →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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