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IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent

by Beckman Coulter Inc.

Ref 447070

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 Number150995901447070KS Basic UDI-DI Date1 Jun 2023RegisteredStatusActive
European UnionCE/IVDR EUDAMED Number150995901447070KS Basic UDI-DI Date1 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590226947 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  • Withdrawn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
IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent EUDAMED
Immage GUDID
Generic Name
Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
447070
Primary DI / UDI-DI
15099590226947, D-447070PV
Basic UDI-DI
150995901447070KS, B-447070PV
FDA Product Code
DHR
EMDN Code
W01021110 Rheumatoid factors
GMDN Term
Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5775
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

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Properties

  • Single Use
  • Human Tissues
  • 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