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OTS™ Tracer CB

by Ortoma AB Sweden EUDAMED

Ref 30-153

EMDN Z12011401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735013752OTSTracersSP Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
OTS Tracers
Model / Reference
30-153
Primary DI / UDI-DI
07350137520135
Basic UDI-DI
735013752OTSTracersSP
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
  • Sterile
Other properties (12)
  • 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 9ff58133-7773-44fe-900c-ae96bb00726f 61 fields · synced 24 Oct 2026