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CB400i

by Biotecnica Instruments S.r.l. EUDAMED

Withdrawn Not intended for the EU market

Ref CB400iModel BT35i

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0803362296394UJ Basic UDI-DIDate6 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
BT35i
Model / Reference
BT35i, CB400i
Primary DI / UDI-DI
08033622964315
Direct Marketing DI
08033622964315

Manufacturer details

EUDAMED SRN
IT-MF-000008115

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