Skip to content

i-Smart 300 Cartridge

by i-SENS, Inc. 10 variants

Ref 6524

Active European Union

CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08806712903125 Basic UDI-DI 08806712903125UDI-DIDate8 Oct 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
6524
Primary DI / UDI-DI
08806712903125
Basic UDI-DI
B-08806712903125
EMDN Code
W0101060610 Blood gas incl. electrolytes / metabolites - multi use cassette
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000009173
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from i-SENS, Inc.

See all devices from i-SENS, Inc. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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