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Kaluza C Perpetual Education License

by Beckman Coulter Inc.

Ref C10578

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
European UnionCE/IVDR EUDAMED Number150995901FCANSYSSWJ2 Basic UDI-DI 15099590705121UDI-DIDate12 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590705121 UDI-DI Date30 Mar 2018ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Kaluza C Perpetual Education License EUDAMED
Kaluza C GUDID
Generic Name
Laboratory instrument/analyser application software IVD
Device Name
Kaluza C Software
Model / Ref / Catalog
C10578, Perpetual Education License
Primary DI / UDI-DI
15099590705121
Basic UDI-DI
150995901FCANSYSSWJ2
FDA Product Code
JQP
EMDN Code
W0202040182 Cytoflowmeters - software accessories
GMDN Term
Laboratory instrument/analyser application software IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2100
Special Device Type
Software
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
C10578
GUDID
Perpetual Education License
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

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No