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Biochemistry Analyzer Ax - 400OPEN

by Gmt SARL France EUDAMED

Ref AX400Model AX300OPEN, AX300CLOSED, AX400OPEN, AX400CLOSED

EMDN W0201010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770028922AX000TC Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Biochemistry Analyzer
Model / Reference
AX300OPEN, AX300CLOSED, AX400OPEN, AX400CLOSED, AX400
Primary DI / UDI-DI
03770028922970
Basic UDI-DI
3770028922AX000TC
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000025248

Other devices from Gmt SARL

See all devices from Gmt SARL →

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 5f611b7f-b5d0-4e0f-b76c-0760d40cee02 61 fields · synced 23 Oct 2026