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<eudamedExport entity="devices">
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    <udiDi>G500A020040700</udiDi>
    <basicUdiDi>B-G500A020040700</basicUdiDi>
    <tradeName>SORATH, SORATH ORTHO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02004070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.385Z</lastUpdated>
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  <row>
    <udiDi>G500A129040030</udiDi>
    <basicUdiDi>B-G500A129040030</basicUdiDi>
    <tradeName>SORATH, SORATH ORTHO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A12904003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.363Z</lastUpdated>
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  <row>
    <udiDi>G500A129040050</udiDi>
    <basicUdiDi>B-G500A129040050</basicUdiDi>
    <tradeName>SORATH, SORATH ORTHO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A12904005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.331Z</lastUpdated>
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    <udiDi>G500A167010060</udiDi>
    <basicUdiDi>B-G500A167010060</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010080</udiDi>
    <basicUdiDi>B-G500A167010080</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010100</udiDi>
    <basicUdiDi>B-G500A167010100</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010120</udiDi>
    <basicUdiDi>B-G500A167010120</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010140</udiDi>
    <basicUdiDi>B-G500A167010140</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010160</udiDi>
    <basicUdiDi>B-G500A167010160</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010200</udiDi>
    <basicUdiDi>B-G500A167010200</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010220</udiDi>
    <basicUdiDi>B-G500A167010220</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010240</udiDi>
    <basicUdiDi>B-G500A167010240</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010260</udiDi>
    <basicUdiDi>B-G500A167010260</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010280</udiDi>
    <basicUdiDi>B-G500A167010280</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010300</udiDi>
    <basicUdiDi>B-G500A167010300</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010320</udiDi>
    <basicUdiDi>B-G500A167010320</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010340</udiDi>
    <basicUdiDi>B-G500A167010340</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010360</udiDi>
    <basicUdiDi>B-G500A167010360</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010380</udiDi>
    <basicUdiDi>B-G500A167010380</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A167010400</udiDi>
    <basicUdiDi>B-G500A167010400</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16701040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:38:47.012Z</lastUpdated>
  </row>
</eudamedExport>