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<eudamedExport entity="devices">
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    <udiDi>00858704006893</udiDi>
    <basicUdiDi>B-00858704006893</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Adapter,Implant,Str Impactr,1/4-28,DJO</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:51.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006862</udiDi>
    <basicUdiDi>B-00858704006862</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Adapter,Implant,Str Impactr,3/8-16,S&amp;N</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403029</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:47.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006855</udiDi>
    <basicUdiDi>B-00858704006855</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Adapter,Implant,Str Impactr,7/16-20,DPY</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:47.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006633</udiDi>
    <basicUdiDi>B-00858704006633</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Holding Sleeve, OrthAlign</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:46.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006602</udiDi>
    <basicUdiDi>B-00858704006602</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Hex Driver - 3.5mm, Teardrop</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:45.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006596</udiDi>
    <basicUdiDi>B-00858704006596</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Acetabular Implant Impactor, Straight</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:40.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006572</udiDi>
    <basicUdiDi>B-00858704006572</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Adapter,Implant,Str Impactr,5/16-24,ZIM</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:39.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006565</udiDi>
    <basicUdiDi>B-00858704006565</basicUdiDi>
    <tradeName>OrthAlign Plus</tradeName>
    <deviceName>Adapter,Implant,Str Impactr,3/8-24,S/B</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:39.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006480</udiDi>
    <basicUdiDi>B-00858704006480</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Femoral Drill Guide, Neutral</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402418</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:38.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006459</udiDi>
    <basicUdiDi>B-00858704006459</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Threaded Pin, Headless, 65mm</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402069</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:34.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006442</udiDi>
    <basicUdiDi>B-00858704006442</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Threaded Pin, Headed, 46mmm</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402068</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:33.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006435</udiDi>
    <basicUdiDi>B-00858704006435</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Pin Driver, Tri-Flat, 3.2mm</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403189</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:32.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006374</udiDi>
    <basicUdiDi>B-00858704006374</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>2.5mm Ball Driver</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402048</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:31.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006367</udiDi>
    <basicUdiDi>B-00858704006367</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>KneeAlign 2 Mounting Bracket</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:27.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006350</udiDi>
    <basicUdiDi>B-00858704006350</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Femoral Cutting Block</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:26.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006343</udiDi>
    <basicUdiDi>B-00858704006343</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Distal Guide Assembly</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402043</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:25.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006336</udiDi>
    <basicUdiDi>B-00858704006336</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>MicroBlock Assembly</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402042</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:24.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006329</udiDi>
    <basicUdiDi>B-00858704006329</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Universal Tibial Cutting Block</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401612</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:20.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006282</udiDi>
    <basicUdiDi>B-00858704006282</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>KneeAlign 2 Tibial Jig Body, Streamlined</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401616</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:19.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858704006268</udiDi>
    <basicUdiDi>B-00858704006268</basicUdiDi>
    <tradeName>KneeAlign 2</tradeName>
    <deviceName>Calf Strap</deviceName>
    <manufacturerName>OrthAlign, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000027362</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0908</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401592</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:19.070Z</lastUpdated>
  </row>
</eudamedExport>