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Coulter

by Beckman Coulter Inc. 7 variants

Ref 628027

Active European Union

CE IVDR

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995909HEMCONTROLHH Basic UDI-DI 15099590816360UDI-DIDate20 Oct 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device name
COULTER 6C Cell Control
Model / reference
628027
Primary DI / UDI-DI
15099590816360
Basic UDI-DI
150995909HEMCONTROLHH
EMDN code
W0103010503 Multilevel blood controls
Device class
Class C
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

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

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains substances of microbial origin: No
  • IVD kit: No
  • Self-testing: No
  • Near-patient testing: No
  • Companion diagnostics: No
  • IVD instrument: No
  • New device: No