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i-Smart 30 Cartridge E5

by i-SENS, Inc. 7 variants

Ref POCECT002-100T3WModel POCECT002

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 linked in EUDAMED

A group certificate may exist

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/IVDR Number8806712POCECT002GV Basic UDI-DI 08806712906003UDI-DIDate1 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
POCECT002, POCECT002-100T3W
Primary DI / UDI-DI
08806712906003
Basic UDI-DI
8806712POCECT002GV
EMDN Code
W01010404 Multiple parameters (mix of all) - clin. chem lab r.
Device Class
Class B
EU market of registration
Lithuania

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 (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