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QCA Bio 100

by Edif Instruments S.r.l. Italy EUDAMED

Ref ES00004-AV6Model Core - Automated Immunochemistry Analyser EMDN W0201010101,W0201020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805360894ES000044Z Basic UDI-DIDate24 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Core
Model / Reference
Core - Automated Immunochemistry Analyser, ES00004-AV6
Primary DI / UDI-DI
80536089416976
Basic UDI-DI
805360894ES000044Z
Direct Marketing DI
80536089416976
EMDN Code
W0201010101,W0201020102
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009556

Other devices from Edif Instruments S.r.l.

See all devices from Edif Instruments S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 990e4f2f-12fc-4b23-94c6-ca8a58904b08 61 fields · synced 23 Oct 2026