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EC Biosensor

by Erba Lachema s.r.o. EUDAMED

Active European Union

Ref REG00064

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8592156CCBS0043RD Basic UDI-DIDate13 Aug 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  • Withdrawn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

Model / Reference
REG00064
Primary DI / UDI-DI
08592156184915
Basic UDI-DI
8592156CCBS0043RD
EMDN Code
W01010803 Multiple electrolytes only - electrodes/biosensors
Device Class
Class B
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000024067

Other devices from Erba Lachema s.r.o.

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No