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Smetsp

by Nordic Kinetics AB Sweden EUDAMED

Ref SMETSP-LR

EMDN Z12062692

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735017913SMETSP-CE-I6F Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Sine Monitoring Essential Tremor Smartphone
Model / Reference
SMETSP-LR
Primary DI / UDI-DI
07350179130019
Basic UDI-DI
735017913SMETSP-CE-I6F
EMDN Code
Z12062692 Dynamometric systems for movement analysis - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000052241

Other devices from Nordic Kinetics AB

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 (1)

  • EUDAMED 5cc33d04-3666-4224-a58c-1fcf7af5a09e 61 fields · synced 23 Oct 2026