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    <tradeName>OTS™ Aufsatzadapter Fix OT</tradeName>
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    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
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    <udiDi>07350137520081</udiDi>
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    <tradeName>OTS™ Fräseradapter OTD</tradeName>
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    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
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    <tradeName>OTS™ Einführinstrument-Adapter OTD</tradeName>
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    <manufacturerName>Ortoma AB</manufacturerName>
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    <udiDi>07350137520128</udiDi>
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    <tradeName>OTS™ Tracer PT</tradeName>
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    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <basicUdiDi>735013752OTSTracersSP</basicUdiDi>
    <tradeName>OTS™ Tracer CB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>07350137520593</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Einführinstrument-Adapter OTD Pinnacle gerade</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>07350137520647</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Messschraube 15 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T07:21:13.527Z</lastUpdated>
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    <udiDi>07350137520654</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Messschraube 8 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
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    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>07350137520661</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Gewindestift 4 x 150 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.483Z</lastUpdated>
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    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Messschraubendreher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.468Z</lastUpdated>
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    <udiDi>07350137520968</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Aufsatzadapter Twin OT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-142</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.418Z</lastUpdated>
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    <udiDi>07350137521002</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Gewindestifteindreher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.401Z</lastUpdated>
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    <udiDi>07350137521019</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Einführinstrument-Adapter OTD gerade</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>30-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.370Z</lastUpdated>
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    <udiDi>07350137521026</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Kalibrieradaptereinheit OTD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-154</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.346Z</lastUpdated>
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    <udiDi>07350137521033</udiDi>
    <basicUdiDi>735013752OTSInstrument39</basicUdiDi>
    <tradeName>OTS™ Kalibrieradaptereinheit OTD Emphasys</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortoma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>30-204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:21:13.307Z</lastUpdated>
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    <udiDi>07540209955129</udiDi>
    <basicUdiDi>7540209955-NC-REUSDA</basicUdiDi>
    <tradeName>•	Frontal Seeker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Claronav Kolahi</manufacturerName>
    <manufacturerSrn>CA-MF-000037841</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>950-NE-FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:19.932Z</lastUpdated>
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    <udiDi>07540209955136</udiDi>
    <basicUdiDi>7540209955-NC-REUSDA</basicUdiDi>
    <tradeName>Maxillary Seeker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Claronav Kolahi</manufacturerName>
    <manufacturerSrn>CA-MF-000037841</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T07:18:19.915Z</lastUpdated>
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    <udiDi>07540209955143</udiDi>
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    <tradeName>Bayonet Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Claronav Kolahi</manufacturerName>
    <manufacturerSrn>CA-MF-000037841</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T07:18:19.902Z</lastUpdated>
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    <udiDi>07540209955150</udiDi>
    <basicUdiDi>7540209955-NC-REUSDA</basicUdiDi>
    <tradeName>Registration Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Claronav Kolahi</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-06-16T07:18:19.888Z</lastUpdated>
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    <udiDi>07540209955167</udiDi>
    <basicUdiDi>7540209955-NC-REUSDA</basicUdiDi>
    <tradeName>Tip Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Claronav Kolahi</manufacturerName>
    <manufacturerSrn>CA-MF-000037841</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T07:18:19.871Z</lastUpdated>
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