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UniCel DxI Access Immunoassay Systems Wash Buffer II

by Beckman Coulter Inc.

Ref A79784

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995909DxIWBIIDilFC Basic UDI-DI 15099590817664UDI-DIDate1 Sep 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  • Withdrawn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

Model / Reference
A79784
Primary DI / UDI-DI
15099590817664
Basic UDI-DI
150995909DxIWBIIDilFC
EMDN Code
W0102010114 Buffers (unassignable), supplem. reagents, etc (ig's)
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000051071
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

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Properties

  • Reagent
  • New Device

Other properties (9)

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