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RapidHemo Reagent

by ZOVEC diagnostics GmbH Germany EUDAMED

Ref RapidHemo ReagentModel RapidHemo EMDN W0103010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426257539RapidHemoHNL Basic UDI-DIDate17 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
RapidHemo Reagent
RapidHemo
Device Name
RapidHemo Integrated Analyzer
Model / Reference
RapidHemo, RapidHemo Reagent
Primary DI / UDI-DI
42625753900160, 42625753900092
Basic UDI-DI
426257539RapidHemoHNL
EMDN Code
W0103010199, W0202010101
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
DE-MF-000035393

Other devices from ZOVEC diagnostics GmbH

See all devices from ZOVEC diagnostics GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED 84844574-6ff1-4a53-b3cc-7e10face8d12 61 fields · synced 22 Oct 2026
  • EUDAMED 42625753900092|426257539RAPIDHEMOHNL 61 fields · synced 18 May 2026