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Stat-On

by SENSE4CARE, S.L. Spain EUDAMED

Ref 5-2-1 STAT-ON, STAT-ON

EMDN Z12062502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843707123195521STAT-ONM4 Basic UDI-DIDate9 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
5-2-1 STAT-ON, STAT-ON
Primary DI / UDI-DI
08437023195017, 08437023195048
Basic UDI-DI
843707123195521STAT-ONM4
Direct Marketing DI
08437023195017
EMDN Code
Z12062502 Kinematic inertial motion capture analysis systems
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000013289

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED fafa4f6d-cd7a-4a3a-95bb-51da912e9260 61 fields · synced 22 Oct 2026
  • EUDAMED 08437023195048|843707123195521STAT-ONM4 61 fields · synced 17 Jul 2026