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OTS™ Hüftführungssystem

by Ortoma AB Sweden EUDAMED

Ref 30-101

EMDN Z12011401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735013752OTSHipLY Basic UDI-DIDate21 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
OTS Hip Guide
Model / Reference
30-101
Primary DI / UDI-DI
07350137520012
Basic UDI-DI
735013752OTSHipLY
EMDN Code
Z12011401 Surgical navigation system
Device Class
Class IIb
Medical Purpose
The OTS Hip Guide is intended as an intraoperative real-time system to enable navigated surgery. A CT-based 3D planned result, where landmarks can be identified on preoperative CT-based anatomical structures, acts as a reference during intraoperative positioning of Tools and implants relative to rigid anatomical structures in orthopedic procedures.

Manufacturer details

EUDAMED SRN
SE-PR-000048670

Other devices from Ortoma AB

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED e52dfbd7-5452-4edf-ac2f-3ddc5bf85b08 61 fields · synced 23 Oct 2026