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<eudamedExport entity="devices">
  <row>
    <udiDi>07540261025853</udiDi>
    <basicUdiDi>B-07540261025853</basicUdiDi>
    <tradeName>tremoflo C-100 Airwave Oscillometry System &amp; Accessories - ERT US Edition</tradeName>
    <deviceName>tremoflo C-100 Airwave Oscillometry System &amp; Accessories - ERT US Edition</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1025853</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:26.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261021893</udiDi>
    <basicUdiDi>B-07540261021893</basicUdiDi>
    <tradeName>tremoflo C-100 Kit - Lemon UK Edition</tradeName>
    <deviceName>tremoflo C-100 Kit - Lemon UK Edition</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102189</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:25.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261021107</udiDi>
    <basicUdiDi>B-07540261021107</basicUdiDi>
    <tradeName>tremoflo C-100 Kit - Ganshorn - EU Edition</tradeName>
    <deviceName>tremoflo C-100 Kit - Ganshorn - EU Edition</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:24.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261020797</udiDi>
    <basicUdiDi>B-07540261020797</basicUdiDi>
    <tradeName>tremoflo C-100 Kit - Ganshorn - SpiroDef Mouthpiece Variant Filter Compatible</tradeName>
    <deviceName>tremoflo C-100 Kit - Ganshorn - SpiroDef Mouthpiece Variant Filter Compatible</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:23.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261020698</udiDi>
    <basicUdiDi>B-07540261020698</basicUdiDi>
    <tradeName>Calibrated Reference Load 15 cmH2O.s/L (2 Year Clinical Trial Use)</tradeName>
    <deviceName>Calibrated Reference Load 15 cmH2O.s/L (2 Year Clinical Trial Use)</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102069</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261020025</udiDi>
    <basicUdiDi>B-07540261020025</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System &amp; Accessories - UK Edition</tradeName>
    <deviceName>tremoflo C100 Airwave Oscillometry System &amp; Accessories - UK Edition</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:18.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261019234</udiDi>
    <basicUdiDi>B-07540261019234</basicUdiDi>
    <tradeName>tremoflo C100 Support Arm</tradeName>
    <deviceName>tremoflo C100 Support Arm</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101923</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:18.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261017629</udiDi>
    <basicUdiDi>B-07540261017629</basicUdiDi>
    <tradeName>tremoflo C-100 Kit Vitalograph - Healthcare Edition</tradeName>
    <deviceName>tremoflo C-100 Kit Vitalograph - Healthcare Edition</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101762</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:17.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261017612</udiDi>
    <basicUdiDi>B-07540261017612</basicUdiDi>
    <tradeName>tremoflo C-100 Kit Vitalograph - Clinical Trial Edition</tradeName>
    <deviceName>tremoflo C-100 Kit Vitalograph - Clinical Trial Edition</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101761</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:13.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261015960</udiDi>
    <basicUdiDi>B-07540261015960</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System Unit - Lemon PFT filter compatible</tradeName>
    <deviceName>tremoflo C100 Airwave Oscillometry System Unit - Lemon PFT filter compatible</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:12.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261014901</udiDi>
    <basicUdiDi>B-07540261014901</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System Unit - Suregard PFT filter compatible</tradeName>
    <deviceName>tremoflo C100 Airwave Oscillometry System Unit - Suregard PFT filter compatible</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101490</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:11.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261013362</udiDi>
    <basicUdiDi>B-07540261013362</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System Unit - ClearFlo PFT filter compatible</tradeName>
    <deviceName>tremoflo C100 Airwave Oscillometry System Unit - ClearFlo PFT filter compatible</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101336</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:10.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261010590</udiDi>
    <basicUdiDi>B-07540261010590</basicUdiDi>
    <tradeName>Calibrated Reference Load 15cmH2O.s/L</tradeName>
    <deviceName>Calibrated Reference Load 15cmH2O.s/L</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:06.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261009860</udiDi>
    <basicUdiDi>B-07540261009860</basicUdiDi>
    <tradeName>Calibrated Reference Load 2cmH2O.s/L</tradeName>
    <deviceName>Calibrated Reference Load 2cmH2O.s/L</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100986</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:48:06.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261014215</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System - ClearFlo F100 PFT Filter</tradeName>
    <deviceName>tremoflo</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101421</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:44.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261014222</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System - Nose Clip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101422</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261016356</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>clearflo F-100 - 100 Airwave Oscillometry Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101635</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261016646</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Sensor Module - ClearFlo Compatible</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101664</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261016882</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Support Arm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101688</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261019470</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo Molded Test Load 15R - Characterized</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101947</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.026Z</lastUpdated>
  </row>
</eudamedExport>