Skip to content

SeptiLoop

by Loop Diagnostics S.L.

Ref SL001Model SeptiLoop

Active European Union

CE IVDR

Valid until

24 Jul 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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 NumberV76 121228 0001 Date22 Sep 2026IssuedStatusActive expires 24 Jul 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 121228 0001 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    22 Sep 2026
    Expires
    24 Jul 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
SeptiLoop, SL001
Primary DI / UDI-DI
08437024928003
Basic UDI-DI
8437024928SL0014W
EMDN Code
W0105090199 Bacteriology - rt & poc - other
Device Class
Class C
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000047379

Other devices from Loop Diagnostics S.L.

Properties

  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No