Skip to content

OTS™ Medizinisches elektrisches System

by Ortoma AB Sweden EUDAMED

Ref 30-226 EMDN Z12011401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735013752OTSMESHC Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
OTS Medical Electrical System
Model / Reference
30-226
Primary DI / UDI-DI
07350137520890
Basic UDI-DI
735013752OTSMESHC
EMDN Code
Z12011401 Surgical navigation system
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000034945

Other devices from Ortoma AB

See all devices from Ortoma 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 da20e861-b117-4d91-ab99-42920105a1bf 61 fields · synced 24 Oct 2026