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PCT (Procalcitonin) Rapid Quantitative Test

by Hunan Ehome Health Technology Co., Ltd. EUDAMED

Active European Union

Ref HU-RE-F07F046001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-300021BUN Basic UDI-DIDate12 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
HU-RE-F07F046001
Primary DI / UDI-DI
D-300021BUN
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000045177
Authorised representative
Medunion S.L. ES-AR-000019366

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