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<eudamedExport entity="devices">
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    <udiDi>10817377023016</udiDi>
    <basicUdiDi>08173770211440008E</basicUdiDi>
    <tradeName>FastTrack Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-44200-7510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:19.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817377023023</udiDi>
    <basicUdiDi>08173770211440008E</basicUdiDi>
    <tradeName>FastTrack Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-44300-7510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:19.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817377023108</udiDi>
    <basicUdiDi>08173770213400008C</basicUdiDi>
    <tradeName>EMG Surface Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13-31000-0050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:19.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222455</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2110701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222417</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2110700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223254</udiDi>
    <basicUdiDi>729010922AC21508MX</basicUdiDi>
    <tradeName>WatchPAT™ONE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC2111801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223278</udiDi>
    <basicUdiDi>729010922AC21508MX</basicUdiDi>
    <tradeName>WatchPAT™ONE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC2111800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222103</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>uPAT™ Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2101300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223483</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>uPAT™ Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2111303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223063</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>uPAT™ Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC2101330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:18.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223339</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>uPAT™ Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC2101301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223490</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC3000103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223506</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC3000113</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223193</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC3000115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222288</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC3000110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223537</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC3001115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222813</udiDi>
    <basicUdiDi>729010922AC20001LH</basicUdiDi>
    <tradeName>07290109222813</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2000110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223520</udiDi>
    <basicUdiDi>729010922AC20001LH</basicUdiDi>
    <tradeName>07290109223520</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2000113</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223346</udiDi>
    <basicUdiDi>729010922AC20001LH</basicUdiDi>
    <tradeName>07290109223346</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC2001110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223117</udiDi>
    <basicUdiDi>729010922AC20001LH</basicUdiDi>
    <tradeName>07290109223117</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>AC2000130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:17.380Z</lastUpdated>
  </row>
</eudamedExport>