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OneTwo Insights

by OneTwo Analytics AB

Ref 07350158330041Model 1.9.0, 1.0.0

Active European Union

CE MDR CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number735015833INSIGHTS43 Basic UDI-DI 07350158330041UDI-DIDate28 Apr 2026RegisteredStatusActive
European UnionCE/MDR Number735015833INSIGHTS43 Basic UDI-DI 07350158330041UDI-DIDate28 Apr 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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Model / Reference
1.9.0, 07350158330041, 1.0.0
Primary DI / UDI-DI
07350158330041
Basic UDI-DI
735015833INSIGHTS43, B-07350158330041
Direct Marketing DI
07350158330041
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000049462

Other devices from OneTwo Analytics AB

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