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DxH ECO Cell Lyse (1L)

by Beckman Coulter Inc.

Ref C67251Model Coulter DxH Cell Lyse

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15099590744854 UDI-DI Date15 Dec 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number150995901HEMLYSEQK Basic UDI-DI 15099590744854UDI-DIDate13 May 2022RegisteredStatusActive

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
DxH ECO Cell Lyse (1L) EUDAMED
DxH GUDID
Generic Name
Full blood count IVD, reagent
Device Name
Coulter DxH Cell Lyse
Model / Ref / Catalog
Coulter DxH Cell Lyse, C67251
Primary DI / UDI-DI
15099590744854
Basic UDI-DI
150995901HEMLYSEQK
FDA Product Code
GGK
EMDN Code
W0202010185 Automated whole blood hematology analysers - consumables
GMDN Term
Full blood count IVD, reagent
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.8540
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Reagent
  • New Device
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No