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High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)

by Beckman Coulter Inc.

Ref 378020

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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 NumberB-378020Q9 Basic UDI-DI D-378020Q9UDI-DIDate10 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-378020Q9 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200) EUDAMED
Synchron GUDID
Generic Name
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
378020
Primary DI / UDI-DI
D-378020Q9 EUDAMED
15099590228682 GUDID
Basic UDI-DI
B-378020Q9
FDA Product Code
NQD
EMDN Code
W0102152203 Specific protein standards and calibrators
GMDN Term
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5270
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-378020Q9
GUDID
15099590228682
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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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