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SepsiBiyo

by Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇. 10 variants

Ref TB 104

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 Number86852392493TB104C2 Basic UDI-DI 08685239249363UDI-DIDate18 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  • Withdrawn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
Mycobacteria Blood Culture Bottle
Model / Reference
TB 104
Primary DI / UDI-DI
08685239249363
Basic UDI-DI
86852392493TB104C2
Direct Marketing DI
08685239249363
EMDN Code
W0104010504 Bottles for automated blood culture
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000054086

Other devices from Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇.

See all devices from Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Ltd. Şti̇. →

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