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    <tradeName>FEP Circuit S/A W/O Filters</tradeName>
    <deviceName>FEP Circuit S/A W/O Filters</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1069211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:42.615Z</lastUpdated>
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    <udiDi>00606959042063</udiDi>
    <basicUdiDi>B-00606959042063</basicUdiDi>
    <tradeName>MPV Support System Kit</tradeName>
    <deviceName>MPV Support System Kit</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1102862</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:41.015Z</lastUpdated>
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    <udiDi>00606959040199</udiDi>
    <basicUdiDi>B-00606959040199</basicUdiDi>
    <tradeName>DreamStation Flow Generator Cover</tradeName>
    <deviceName>DreamStation Flow Generator Cover</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1128163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:33.804Z</lastUpdated>
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    <udiDi>00606959028470</udiDi>
    <basicUdiDi>B-00606959028470</basicUdiDi>
    <tradeName>DreamStation CPAP w/ Humid/HT, LA</tradeName>
    <deviceName>DreamStation CPAP w/ Humid/HT, LA</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX200T15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:28.203Z</lastUpdated>
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    <udiDi>00606959028456</udiDi>
    <basicUdiDi>B-00606959028456</basicUdiDi>
    <tradeName>DreamStation CPAP, LA</tradeName>
    <deviceName>DreamStation CPAP, LA</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX200S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:27.406Z</lastUpdated>
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    <udiDi>00606959026162</udiDi>
    <basicUdiDi>B-00606959026162</basicUdiDi>
    <tradeName>Trilogy Passive Exhalation Circuit, Pediatric</tradeName>
    <deviceName>Trilogy Passive Exhalation Circuit, Pediatric</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:15.411Z</lastUpdated>
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    <udiDi>00606959026155</udiDi>
    <basicUdiDi>B-00606959026155</basicUdiDi>
    <tradeName>Trilogy Passive Exhalation Circuit, Adult</tradeName>
    <deviceName>Trilogy Passive Exhalation Circuit, Adult</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052066</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:14.600Z</lastUpdated>
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  <row>
    <udiDi>00606959026148</udiDi>
    <basicUdiDi>B-00606959026148</basicUdiDi>
    <tradeName>Trilogy Active with PAP Exhalation Circuit, Pediatric</tradeName>
    <deviceName>Trilogy Active with PAP Exhalation Circuit, Pediatric</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:10.601Z</lastUpdated>
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  <row>
    <udiDi>00606959026131</udiDi>
    <basicUdiDi>B-00606959026131</basicUdiDi>
    <tradeName>Trilogy Active with PAP Exhalation Circuit, Adult</tradeName>
    <deviceName>Trilogy Active with PAP Exhalation Circuit, Adult</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:09.790Z</lastUpdated>
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  <row>
    <udiDi>00606959022331</udiDi>
    <basicUdiDi>B-00606959022331</basicUdiDi>
    <tradeName>15MM Heated Tube</tradeName>
    <deviceName>15MM Heated Tube</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:03.387Z</lastUpdated>
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  <row>
    <udiDi>00606959005297</udiDi>
    <basicUdiDi>B-00606959005297</basicUdiDi>
    <tradeName>Active Exhalation Device with PAP</tradeName>
    <deviceName>Active Exhalation Device with PAP</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1053716</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:09:17.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959005228</udiDi>
    <basicUdiDi>B-00606959005228</basicUdiDi>
    <tradeName>Trilogy Active Flow Exhalation Circuit, Pediatric</tradeName>
    <deviceName>Trilogy Active Flow Exhalation Circuit, Pediatric</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1068838</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:09:16.923Z</lastUpdated>
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  <row>
    <udiDi>07290017096728</udiDi>
    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName>Ventway Sparrow</deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-100MR</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:55:12.293Z</lastUpdated>
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    <udiDi>07290017096841</udiDi>
    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-9000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.243Z</lastUpdated>
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    <udiDi>07290017096803</udiDi>
    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.187Z</lastUpdated>
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    <udiDi>07290017096834</udiDi>
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    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.120Z</lastUpdated>
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    <udiDi>07290017096810</udiDi>
    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-1000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.084Z</lastUpdated>
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    <udiDi>07290017096742</udiDi>
    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-1000MR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:38.799Z</lastUpdated>
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    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-9000MR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:38.393Z</lastUpdated>
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    <basicUdiDi>7290017096VentwayWY</basicUdiDi>
    <tradeName>Ventway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-900MR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:38.326Z</lastUpdated>
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