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ANALIZZATORE CHIM-CLIN. BT 1500i

by Biotecnica Instruments S.r.l. 3 variants

Ref BT 1500i-CModel BT 1500i

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0803362296467UL Basic UDI-DI 08033622964704UDI-DIDate6 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
ANALIZZATORE CHIM-CLIN. BT 1500i
Model / Reference
BT 1500i, BT 1500i-C
Primary DI / UDI-DI
08033622964704
Basic UDI-DI
0803362296467UL
Direct Marketing DI
08033622964704
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000008115

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Properties

  • 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