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C-reactive protein (CRP )Assay Kit (Fluorescent lmmunochromatography)

by Chengdu DynoDx Medical Technologies Co., Ltd. 6 variants

Ref CPR-1test/boxModel 1 test/box,

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-06976963608581 Basic UDI-DI 06976963608581UDI-DIDate9 Oct 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  • Withdrawn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 (CRP )Assay Kit (Fluorescent lmmunochromatography)
Model / Reference
1 test/box, CPR-1test/box
Primary DI / UDI-DI
06976963608581
Basic UDI-DI
B-06976963608581
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000059703
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Chengdu DynoDx Medical Technologies Co., Ltd.

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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