Skip to content

Clinical Insight

by Nexus Enterprise Diagnostics B.V.

Model Variant 1: Clinical Assistant; Variant 2: Clinical Insight

Active European Union

CE MDR

Valid until

3 Jun 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number87202997804SUITEJ5 Basic UDI-DI 08720299780422UDI-DIDate27 May 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE24/00000145 Restricted

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    17 Sep 2024
    Expires
    3 Jun 2029
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Clinical Product Suite
Model / Reference
Variant 1: Clinical Assistant, Variant 2: Clinical Insight
Primary DI / UDI-DI
08720299780422
Basic UDI-DI
87202997804SUITEJ5
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000022846

Other devices from Nexus Enterprise Diagnostics B.V.

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No