Skip to content

Breath Collection Kit Sobrecrecimiento Bacteriano (Sibo)

by Home Diagnostics S.L

Ref REFERENCIA 11

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number843702490911EK Basic UDI-DI 08437024909118UDI-DIDate21 Aug 2024RegisteredStatusActive

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  • Withdrawn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
Breath Collection Kit Sobrecrecimiento Bacteriano (Sibo)
Model / Reference
REFERENCIA 11
Primary DI / UDI-DI
08437024909118
Basic UDI-DI
843702490911EK
Direct Marketing DI
08437024909118
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000026858

Other devices from Home Diagnostics S.L

See all devices from Home Diagnostics S.L →

Properties

  • Animal Tissues
  • Reagent

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No