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Pct（clia）

by Medcaptain Medical Technology Co., Ltd. United States EUDAMED

Ref MCL02102E

EMDN W0102069013

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06926802603598 Basic UDI-DIDate22 Sep 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06926802603598 Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Pct（clia）
Model / Reference
MCL02102E
Primary DI / UDI-DI
06926802603598
Basic UDI-DI
B-06926802603598, 69268026MD71F00001VR
EMDN Code
W0102069013 Procalcitonin
Device Class
Class IVD General
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000005925
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Medcaptain Medical Technology Co., Ltd.

See all devices from Medcaptain Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 8c023ebd-ced2-47a8-84b7-616c4c1818d9 61 fields · synced 23 Oct 2026
  • EUDAMED 06926802603598|69268026MD71F00001VR 61 fields · synced 20 Oct 2026