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<eudamedExport entity="devices">
  <row>
    <udiDi>10607411500593</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Adult Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with filter.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Salter Labs</manufacturerName>
    <manufacturerSrn>US-MF-000007934</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5005-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500623</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Adult Oral/Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-lock® connection.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Salter Labs</manufacturerName>
    <manufacturerSrn>US-MF-000007934</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5006-2-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413404988</udiDi>
    <basicUdiDi>42504134PSGSC</basicUdiDi>
    <tradeName>JFD5001</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>TOR050C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405190</udiDi>
    <basicUdiDi>42504134SOMNOtouchNIBPXX</basicUdiDi>
    <tradeName>SOMNOtouch NIBP (pediatric)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TON105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405305</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>SOMNOtouch RESP (RIP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405312</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>SOMNOtouch RESP (PLM)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405329</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>Add-on device: SOMNOtouch RESP (PLM)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR120A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405336</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>Add-on device: SOMNOtouch PSG ambulatory (AASM)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR190A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405343</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>Add-on device: SOMNOtouch™ PSG ambulatory (R&amp;K)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR191A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405381</udiDi>
    <basicUdiDi>42504134SOMNOtouchNIBPXX</basicUdiDi>
    <tradeName>SOMNOtouch NIBP incl. ECG sensor with body position</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TON110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405398</udiDi>
    <basicUdiDi>42504134SOMNOtouchNIBPXX</basicUdiDi>
    <tradeName>Add-on device: SOMNOtouch NIBP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TON110A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:02.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406302</udiDi>
    <basicUdiDi>42504134Adapter8Q</basicUdiDi>
    <tradeName>Adaptor for NPT sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN561</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:01.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406340</udiDi>
    <basicUdiDi>42504134iEGurtWD</basicUdiDi>
    <tradeName>Inductive Effort Belt - Size XXL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN663/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:01.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406357</udiDi>
    <basicUdiDi>42504134iEGurtWD</basicUdiDi>
    <tradeName>Inductive Effort Belt - Size XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN664/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:01.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406487</udiDi>
    <basicUdiDi>42504134iEGurtWD</basicUdiDi>
    <tradeName>Inductive Effort Belts</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAS664/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:01.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406883</udiDi>
    <basicUdiDi>42504134SOMNOHDND</basicUdiDi>
    <tradeName>SOMNO HD PSG pediatric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGD202Ap</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:00.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406890</udiDi>
    <basicUdiDi>42504134SOMNOHDND</basicUdiDi>
    <tradeName>SOMNO HD RC easy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGD500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:00.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406906</udiDi>
    <basicUdiDi>42504134SleepAdagioDD</basicUdiDi>
    <tradeName>Sleep Adagio Pro with PLM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAD160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:00.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406913</udiDi>
    <basicUdiDi>42504134SleepAdagioDD</basicUdiDi>
    <tradeName>Sleep Adagio PSG combi electrode &amp; PLM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAD200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:00.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406920</udiDi>
    <basicUdiDi>42504134SOMNOHDND</basicUdiDi>
    <tradeName>SOMNO HD PSG pediatric with PTZ Carmera</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGDV202Ap</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T05:34:00.262Z</lastUpdated>
  </row>
</eudamedExport>