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Smartz System [Smartz Pod and software]

by Smartz Operations Pty Ltd

Ref 02876Model 9000

Active European Union

CE MDR

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/MDR Number0934212400SMARTZ9000XJ Basic UDI-DI 09342124000711UDI-DIDate21 Apr 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Smartz Pod
Model / Reference
9000, 02876
Primary DI / UDI-DI
09342124000711
Basic UDI-DI
0934212400SMARTZ9000XJ
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
AU-MF-000009445
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Smartz Operations Pty Ltd

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No