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SepsiBiyo

by Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref TB104Model SepsiBiyo EMDN W0104010504

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number86842981255TB104CF Basic UDI-DIDate13 May 2026RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Tuberculosis Blood Culture Bottle
Model / Reference
SepsiBiyo, TB104
Primary DI / UDI-DI
08684298125533
Basic UDI-DI
86842981255TB104CF
Direct Marketing DI
08684298125533
EMDN Code
W0104010504 Bottles for automated blood culture
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000054148

Other devices from Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Li̇mi̇ted Şi̇rketi̇

See all devices from Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Li̇mi̇ted Şi̇rketi̇ →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 6a7978c9-a197-4170-8e53-96e2724bf0a6 61 fields · synced 24 Oct 2026