- Role
- Country
- Date of registration
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EUDAMED last updated this device on May 19, 2026
735013752OTSInstrument39SE-MF-0000349452 warnings recorded — scroll inside the panel to see all entries.
CW010CW011Primary placement in Sweden; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Still on market | |
| Belgium | Still on market | |
| France | Still on market | |
| Ireland | Still on market | |
| Portugal | Still on market |
(01)07350137520968
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12011401SURGICAL NAVIGATION SYSTEM735013752OTSInstrument39On the marketOTS ™ Calibration Adapter Unit OTD735013752OTSInstrument39On the marketOTS ™ Hip Guide Software735013752OTSHipGuideQNOn the marketOTS ™ Hip Plan735013752OTSHipPlanHXOn the marketOTS ™ Inserter Adapter OTD735013752OTSInstrument39On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.