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I.S.E. Electrode CO2

by DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

Ref U13388

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-U1338845 Basic UDI-DI D-U1338845UDI-DIDate29 Jun 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  • Withdrawn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

Device Name
I.S.E. Electrode CO2
Model / Reference
U13388
Primary DI / UDI-DI
D-U1338845
Basic UDI-DI
B-U1338845
EMDN Code
W0101070108 Carbon dioxide (bicarbonate) - electrodes (cc)
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000000254

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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