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C-Reactive Protein Reagent (CRP 2 x 200)

by Beckman Coulter Inc. EUDAMEDGUDID

Active European Union

Ref 465131

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-465131PY Basic UDI-DIDate8 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-465131PY UDI-DIDate24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
C-Reactive Protein Reagent (CRP 2 x 200) EUDAMED
Synchron GUDID
Generic Name
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
465131
Primary DI / UDI-DI
D-465131PY EUDAMED
15099590225391 GUDID
Basic UDI-DI
B-465131PY
FDA Product Code
DCK
EMDN Code
W01021308 High-sensitivity c-.reactive protein
GMDN Term
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5270
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-465131PY
GUDID
15099590225391
Device ClassEUDAMED
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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See all devices from Beckman Coulter, Inc. →

Properties

  • Single Use
  • 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
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No