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Sienna Ultimate

by EMS Handels Gesellschaft m.b.H. EUDAMED510(k)

Active European Union and United States

Ref SU/EEGModel Sienna Ultimate510(k) K171397

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912004097DX1CY Basic UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK171397 Date6 Oct 2017ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) 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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k)

Model / Reference
Sienna Ultimate, SU/EEG
Primary DI / UDI-DI
09120040973339
Basic UDI-DI
912004097DX1CY
Direct Marketing DI
09120040973339
510(k) Number
FDA Product Code
GWL
EMDN Code
N010199 Neurophysiology devices - other
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 882.1835
Market of Registration
Austria
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Manufacturer details

EUDAMED SRN
AT-MF-000002599

From the manufacturer

Manufacturer's product page: SIENNA Ultimate

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

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