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Coulter 5C Cell Control

by Beckman Coulter Inc. 4 variants

Ref 7547124

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060464↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-75471242X Basic UDI-DI D-75471242XUDI-DIDate8 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-75471242X UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) 510(k) NumberK060464 Date28 Mar 2006IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Coulter 5C Cell Control EUDAMED
Coulter 5C GUDID
Generic Name
Full blood count IVD, control
Model / Ref / Catalog
7547124
Primary DI / UDI-DI
D-75471242X EUDAMED
15099590230401 GUDID
Basic UDI-DI
B-75471242X
FDA Product Code
JPK
EMDN Code
W0103010503 Multilevel blood controls
GMDN Term
Full blood count IVD, control
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
864.8625
EU market of registration
Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-75471242X
GUDID
15099590230401
Device ClassEUDAMED
Class IVD General
GUDID
Class II

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

  • Single Use
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No