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IMMAGE Ferritin (FER)

by Beckman Coulter Inc.

Ref 447160

Active European Union and United States. Also listed in GUDID (US).

CE IVDR CE IVDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K983340↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-447160PX Basic UDI-DI Date8 Jun 2022RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-447160PX Basic UDI-DI Date8 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-447160PX UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK983340 Date14 Dec 1998IssuedStatusActive

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 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
IMMAGE Ferritin (FER) EUDAMED
IMMAGE Immunochemistry Systems FER Ferritin Reagent EUDAMED
Immage GUDID
Generic Name
Ferritin IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
447160
Primary DI / UDI-DI
D-447160PX, 15099590223373
Basic UDI-DI
B-447160PX, 150995901447160KU
FDA Product Code
DBF
EMDN Code
W0102070102 Ferritin
GMDN Term
Ferritin IVD, kit, enzyme immunoassay (EIA)
Device Class
Class IVD General EUDAMED
Class B EUDAMED
Class II GUDID
Regulation Number
866.5340
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
Class B
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 NoEUDAMEDYesEUDAMED
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • 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
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No