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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 14183
Basic UDI-DI
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class I
Appliance -
Device name (in Estonian) ExcelsiusGPS
Device name (in English) ExcelsiusGPS
Intended use (is Estonian) Robotiline kirurgiline navigeerimisseade, mis võimaldab patsiendi radioloogilisi kujutisi kasutades juhtida reaalajas instrumentide trajektoori mööda kirurgi määratud teed.
Intended use (in English) A robotic surgical navigation device that allows real-time instrument trajectories to be routed along a path determined by a surgeon using patient radiological imaging.
Type/model/article number
Notified body 0297
Manufacturer Globus Medical Inc.
Authorised representative AJW Technology Consulting
In register from 11/05/2019
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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