Skip to content

BT15i

by Biotecnica Instruments S.r.l. EUDAMED

Active European Union

Ref BT15i-A-A, BT15i-B-D, BT15i-B-E, BT15i-B-L, BT15i-B-A, BT15i-B-CModel BT15i

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0803362296418U7 Basic UDI-DIDate9 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
BT15i, BT15i-A-A, BT15i-B-D, BT15i-B-E, BT15i-B-L, BT15i-B-A, BT15i-B-C
Primary DI / UDI-DI
08033622964193, 08033622964223, 08033622964230, 08033622964186, 08033622964278, 08033622964209, 08033622964216
Basic UDI-DI
0803362296418U7
Direct Marketing DI
08033622964193
08033622964223
08033622964230
08033622964186
08033622964278
08033622964209
08033622964216
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Türkiye

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

  • 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