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Immunochemistry Systems UCAL Urine Protein Calibrator

by Beckman Coulter Inc.

Ref 441470

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

CE IVDR CE IVDD

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/IVDD EUDAMED Number150995901441470K4 Basic UDI-DI Date2 Feb 2022RegisteredStatusActive
European UnionCE/IVDR EUDAMED Number150995901441470K4 Basic UDI-DI Date2 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590222673 UDI-DI Date24 Aug 2016ListedStatusListed 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  • Withdrawn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/IVDD, CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Immunochemistry Systems UCAL Urine Protein Calibrator EUDAMED
Immage GUDID
Generic Name
Multiple clinical chemistry protein IVD, calibrator
Model / Ref / Catalog
441470
Primary DI / UDI-DI
15099590222673, D-441470P7
Basic UDI-DI
150995901441470K4, B-441470P7
FDA Product Code
JIX
EMDN Code
W0102152203, W0102152299
GMDN Term
Multiple clinical chemistry protein IVD, calibrator
Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1150
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
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
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

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