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C-Reactive Protein Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)

by Rayto Life and Analytical Sciences Co., Ltd. 5 variants

Ref R05515Model R1: 60mL×2, R2: 15mL×2; 1×1mL

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R055152G Basic UDI-DI D-R055152GUDI-DIDate15 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
C-Reactive Protein Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)
Model / Reference
R1: 60mL×2, R2: 15mL×2, 1×1mL, R05515
Primary DI / UDI-DI
D-R055152G
Basic UDI-DI
B-R055152G
EMDN Code
W01021109 C-reactive protein
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No