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hs-CRP Test Kit (Immunofluorescence Method)

by Wuhan Easydiagnosis Biomedicine Co., Ltd. 2 variants

Ref W-IF2-hs-CRP-40Model 40 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-06978896416189 Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
hs-CRP Test Kit (Immunofluorescence Method)
Model / Reference
40 tests/kit, W-IF2-hs-CRP-40
Primary DI / UDI-DI
06978896416189
Basic UDI-DI
B-06978896416189
EMDN Code
W01021109 C-reactive protein
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000019908
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Wuhan Easydiagnosis Biomedicine Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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