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C reaction protein (supersensitive CRP+conventional CRP) Test Kit (Fluorescence immunochromatography method

by Biobase Poct Co., Ltd 2 variants

Ref 50 tests / kit（DR002-2）, 25 tests / kit（DR002-4）Model 50 tests / kit, 25 tests / kit

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976374750022 Basic UDI-DI Date5 May 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  • Withdrawn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

Model / Reference
50 tests / kit, 50 tests / kit（DR002-2）, 25 tests / kit, 25 tests / kit（DR002-4）
Primary DI / UDI-DI
06976374750022, 06976374750015
Basic UDI-DI
B-06976374750022, B-06976374750015
EMDN Code
W0102160601 C-reactive protein - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045945
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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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