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SepsiBiyo

by Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Li̇mi̇ted Şi̇rketi̇ 5 variants

Ref SB101Model SepsiBiyo

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number86842981255SB101BW Basic UDI-DI 08684298125519UDI-DIDate13 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  • Withdrawn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
Anaerobic Blood Culture Bottle
Model / Reference
SepsiBiyo, SB101
Primary DI / UDI-DI
08684298125519
Basic UDI-DI
86842981255SB101BW
Direct Marketing DI
08684298125519
EMDN Code
W0104010504 Bottles for automated blood culture
Device Class
Class A
EU 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

  • 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