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<eudamedExport entity="devices">
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    <udiDi>10607411700085</udiDi>
    <basicUdiDi>0607411TF20015a_HumidfrVH</basicUdiDi>
    <tradeName>High Flow Oxygen Therapy Kit, (1) #1600HFTLC-7 Nasal (Adult) High Flow TLCannula, (1) #7900 Bubble Humidifier (high flow)</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7907TLC-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:49.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800303</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Adult) Medium Concentration, 7’ (2.1 m) supply tube, elastic strap fixation</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8110-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:49.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800419</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Adult) High concentration non-rebreather, with safety vent, 7’ (2.1 m) supply tube, Elastic strap fixation.</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8130-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:49.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800433</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Adult) High Concentration non-rebreather, with safety vent. 7’ (2.1 m) supply tube with Thread Grip, Elastic strap fixation</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8130TG-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:48.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800457</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Adult), Concentration non-rebreather, with 7’ (2.1 m) supply tube, Elastic Strap fixation.</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8140-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:48.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800464</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Adult), High Concentration non-rebreather, without safety vent. with thread grip connector, with 7’ (2.1 m) supply tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8140TG-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:48.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800495</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Adult), High Concentration non-rebreather, without safety vent. with thread grip connector, with 7’ (2.1 m) supply tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8150TG-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T21:56:48.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500104</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Pediatric Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with male luer style 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5022-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500135</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Adult 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5011-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500265</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Adult Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer style 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5012-1-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500357</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Adult Nasal Pressure Monitoring &amp; Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and filter for pressure monitoring</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5041-7-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500364</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Pediatric Nasal Pressure Monitoring &amp; Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and filter for pressure monitoring</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5049-7-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500401</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Pediatric Nasal Pressure Monitoring &amp; Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5050-7-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411500418</udiDi>
    <basicUdiDi>0607411TF20010_SleepDx9V</basicUdiDi>
    <tradeName>Small Pediatric Nasal Pressure Monitoring &amp; Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5054-7-7-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.564Z</lastUpdated>
  </row>
  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5006-2-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:02.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800761</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Pediatric) High concentration non-rebreather, with safety vent. with 7’ (2.1 m) supply tube, Elastic Strap fixation</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T01:57:33.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411800785</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Pediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1m) supply tube, elastic strap fixation</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1140-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T01:57:33.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411893480</udiDi>
    <basicUdiDi>0607411TF20015a_HumidfrVH</basicUdiDi>
    <tradeName>High Flow Oxygen Therapy Kit, (1) #1600HFTLC-14 Nasal (Adult) High Flow TLCannula, (1) #7900 Bubble Humidifier (high flow)</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7914TLC-14-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T01:57:33.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>10607411940658</udiDi>
    <basicUdiDi>0607411TF20014a_O2MaskLW</basicUdiDi>
    <tradeName>Oxygen Mask (Pediatric) Medium Concentration, 7’ (2,1 m) supply tube, elastic strap fixation with Thread Grip</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1122TG-7-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T01:57:33.094Z</lastUpdated>
  </row>
</eudamedExport>