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<eudamedExport entity="devices">
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    <udiDi>00850231007091</udiDi>
    <basicUdiDi>B-00850231007091</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Guide Pin, 27mm</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L091106</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHTA-GP-27-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:20.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062224</udiDi>
    <basicUdiDi>B-00850045062224</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-SYS-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:04.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062217</udiDi>
    <basicUdiDi>B-00850045062217</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-SYS-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:03.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062200</udiDi>
    <basicUdiDi>B-00850045062200</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-SUL-600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:02.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062194</udiDi>
    <basicUdiDi>B-00850045062194</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-SUM-500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:01.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062187</udiDi>
    <basicUdiDi>B-00850045062187</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-SUS-400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:57.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062170</udiDi>
    <basicUdiDi>B-00850045062170</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-SUP-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:56.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062101</udiDi>
    <basicUdiDi>B-00850045062101</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-MPL-005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:56.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062095</udiDi>
    <basicUdiDi>B-00850045062095</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-MPM-004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:55.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062088</udiDi>
    <basicUdiDi>B-00850045062088</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-MPS-003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:51.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062071</udiDi>
    <basicUdiDi>B-00850045062071</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-MPP-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:50.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045062064</udiDi>
    <basicUdiDi>B-00850045062064</basicUdiDi>
    <tradeName>DryShield</tradeName>
    <deviceName>Dryshield Isolation System and Mouthpieces</deviceName>
    <manufacturerName>Solmetex, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000040024</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-MPX-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:02:49.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898226</udiDi>
    <basicUdiDi>B-00850000898226</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Transcatheter Heart Valve</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:07.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898219</udiDi>
    <basicUdiDi>B-00850000898219</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Transcatheter Heart Valve</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:06.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898202</udiDi>
    <basicUdiDi>B-00850000898202</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Transcatheter Heart Valve</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:03.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898196</udiDi>
    <basicUdiDi>B-00850000898196</basicUdiDi>
    <tradeName>Trilogy Sheath/Dilator</tradeName>
    <deviceName>Trilogy Sheath/Dilator</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-INT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:02.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898189</udiDi>
    <basicUdiDi>B-00850000898189</basicUdiDi>
    <tradeName>Trilogy Loading Tools</tradeName>
    <deviceName>Trilogy Loading Tools Size 27</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-LT-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:01.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898172</udiDi>
    <basicUdiDi>B-00850000898172</basicUdiDi>
    <tradeName>Trilogy Loading Tools</tradeName>
    <deviceName>Trilogy Loading Tools Size 25</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-LT-M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:59.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898165</udiDi>
    <basicUdiDi>B-00850000898165</basicUdiDi>
    <tradeName>Trilogy Loading Tools</tradeName>
    <deviceName>Trilogy Loading Tools Size 23</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-LT-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:57.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898158</udiDi>
    <basicUdiDi>B-00850000898158</basicUdiDi>
    <tradeName>Trilogy Delivery Catheter</tradeName>
    <deviceName>Trilogy Delivery Catheter Size 27</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-DC-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:55.918Z</lastUpdated>
  </row>
</eudamedExport>