Skip to content

Sienna

by EMS Handels Gesellschaft m.b.H. EUDAMED

Active European Union

Ref SE/EEGModel Sienna

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number912004097CX1CT Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-030 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    19 Jun 2024
    Expires
    19 Jun 2029

Specification

EUDAMED

Model / Reference
Sienna, SE/EEG
Primary DI / UDI-DI
09120040973353
Basic UDI-DI
912004097CX1CT
Direct Marketing DI
09120040973353
EMDN Code
N010199 Neurophysiology devices - other
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000002599

Other devices from EMS Handels Gesellschaft m.b.H.

  • EMS Neurostimulator

    Class IIa

  • Angelie EIS

    Class IIa

  • Surpass

    Class IIa

  • Surpass LT

    Class IIa

  • Sienna Ultimate

    Class IIa

  • Unique+

    Class IIa

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