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Procalcitonin/C-Reactive Protein/Serum Amyloid A Test Kit (QDs-FICA)

by Chongqing Juce Life Health Technology Co., Ltd.

Ref DC1201Model 1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/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-06977981880133 Basic UDI-DI 06977981880133UDI-DIDate20 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  • Withdrawn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
1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box, DC1201
Primary DI / UDI-DI
06977981880133
Basic UDI-DI
B-06977981880133
EMDN Code
W0105070599 Multiple infectious - multiplex assays - other
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000053774
Authorised representative
Share info GmbH DE-AR-000005132

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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