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BT3000PLUS S/Ise-Ts-Ups-Stamp.

by Biotecnica Instruments S.r.l. EUDAMED

Active European Union

Ref BT3000P S/I-EModel BT 3000 PLUS SENZA ISE

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0803362296326TZ Basic UDI-DIDate6 Sep 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Bt 3000 P S/I
Model / Reference
BT 3000 PLUS SENZA ISE, BT3000P S/I-E
Primary DI / UDI-DI
08033622963417
Basic UDI-DI
0803362296326TZ
Direct Marketing DI
08033622963417
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000008115

Other devices from Biotecnica Instruments S.r.l.

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Properties

Show 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