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Procalcitonin Assay Kit (Fluorescent Immunochromatography)

by Chengdu DynoDx Medical Technologies Co., Ltd. EUDAMED

Active European Union

Ref PCT,10test/boxModel 10 test/box

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976963608697 Basic UDI-DIDate12 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Procalcitonin Assay Kit (Fluorescent Immunochromatography)
Model / Reference
10 test/box, PCT, 10test/box
Primary DI / UDI-DI
06976963608697
Basic UDI-DI
B-06976963608697
EMDN Code
W01029099 Immunochemistry reagents - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

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

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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