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BT35i

by Biotecnica Instruments S.r.l. Italy EUDAMED

Ref BT35i

EMDN W0201010101

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
BT35i
Model / Reference
BT35i
Primary DI / UDI-DI
08033622963523
Basic UDI-DI
0803362296394UJ
Direct Marketing DI
08033622963523
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A

Manufacturer details

EUDAMED SRN
IT-MF-000008115

Other devices from Biotecnica Instruments S.r.l.

See all devices from Biotecnica Instruments S.r.l. →

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 (1)

  • EUDAMED c5b0e990-6330-47ab-b4fc-f4d76c0bf62b 61 fields · synced 23 Oct 2026