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DxC 6000 AU-20, Chemistry Analyzer DxC 6000 AU AR

by Beckman Coulter K.K.

Ref D13633

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDR Number1509959012DxC6000AUB7 Basic UDI-DI 14987666550083UDI-DIDate6 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
DxC 6000 AU Chemistry Analyzer
Model / Reference
D13633
Primary DI / UDI-DI
14987666550083
Basic UDI-DI
1509959012DxC6000AUB7
EMDN Code
W0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
JP-MF-000051926
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter K.K.

Properties

  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No