<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959023628</udiDi>
    <basicUdiDi>B-00606959023628</basicUdiDi>
    <tradeName>DreamStation Humidifier FR</tradeName>
    <deviceName>DreamStation Humidifier FR</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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:44.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021396</udiDi>
    <basicUdiDi>B-00606959021396</basicUdiDi>
    <tradeName>CoughAssist 70 Series, Water Trap</tradeName>
    <deviceName>CoughAssist 70 Series, Water Trap</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:41.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021389</udiDi>
    <basicUdiDi>B-00606959021389</basicUdiDi>
    <tradeName>CoughAssist E70 Series Oximetry Interface Kit</tradeName>
    <deviceName>CoughAssist E70 Series Oximetry Interface 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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098718</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:25.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021259</udiDi>
    <basicUdiDi>B-00606959021259</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Mouthpiece, 6ft</tradeName>
    <deviceName>CoughAssist 70 Series Circuit, Mouthpiece, 6ft</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090836</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:24.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959006720</udiDi>
    <basicUdiDi>B-00606959006720</basicUdiDi>
    <tradeName>Patient Circuit, CA Trach</tradeName>
    <deviceName>Patient Circuit, CA Trach</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325-9238</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:19.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959006713</udiDi>
    <basicUdiDi>B-00606959006713</basicUdiDi>
    <tradeName>Facemask, Adult, Large, with Hose, Filter, Adapter</tradeName>
    <deviceName>Facemask, Adult, Large, with Hose, Filter, Adapter</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325-9217</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:18.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730004624</udiDi>
    <basicUdiDi>B-00383730004624</basicUdiDi>
    <tradeName>Pediatric Plastic Disposable Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Respiratory Drug Delivery (UK) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002292</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HS715-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:09.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730001951</udiDi>
    <basicUdiDi>B-00383730001951</basicUdiDi>
    <tradeName>InnoSpire Essence</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Respiratory Drug Delivery (UK) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002292</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1112261</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:54:04.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730001890</udiDi>
    <basicUdiDi>B-00383730001890</basicUdiDi>
    <tradeName>InnoSpire Essence</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Respiratory Drug Delivery (UK) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002292</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099967</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:54:03.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730001715</udiDi>
    <basicUdiDi>B-00383730001715</basicUdiDi>
    <tradeName>InnoSpire Elegance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Respiratory Drug Delivery (UK) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002292</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099973</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:54:02.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730001692</udiDi>
    <basicUdiDi>B-00383730001692</basicUdiDi>
    <tradeName>InnoSpire Elegance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Respiratory Drug Delivery (UK) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002292</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099971</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:58.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000800</udiDi>
    <basicUdiDi>B-00383730000800</basicUdiDi>
    <tradeName>LiteTouch Large Mask/Grand Masque</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1082716</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:57.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000794</udiDi>
    <basicUdiDi>B-00383730000794</basicUdiDi>
    <tradeName>LiteTouch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1083783</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:57.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000770</udiDi>
    <basicUdiDi>B-00383730000770</basicUdiDi>
    <tradeName>LiteTouch Medium Mask/Masque Moyen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1082715</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:56.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000749</udiDi>
    <basicUdiDi>B-00383730000749</basicUdiDi>
    <tradeName>LiteTouch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1083785</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:52.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000732</udiDi>
    <basicUdiDi>B-00383730000732</basicUdiDi>
    <tradeName>LiteTouch Small Mask/Petit Masque</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1082714</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:51.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000107</udiDi>
    <basicUdiDi>B-00383730000107</basicUdiDi>
    <tradeName>One way valve Plastic Disposable Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Respiratory Drug Delivery (UK) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002292</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HS714-200</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:45.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383480000594</udiDi>
    <basicUdiDi>B-00383480000594</basicUdiDi>
    <tradeName>LiteAire BASIC</tradeName>
    <deviceName>LiteAire BASIC Collapsible Dual Valved Holding Chamber</deviceName>
    <manufacturerName>Thayer Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026197</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:30.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383480000495</udiDi>
    <basicUdiDi>B-00383480000495</basicUdiDi>
    <tradeName>LiteAire</tradeName>
    <deviceName>LiteAire Collapsible Dual Valved Holding Chamber</deviceName>
    <manufacturerName>Thayer Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026197</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:29.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383480000310</udiDi>
    <basicUdiDi>B-00383480000310</basicUdiDi>
    <tradeName>Counter Incrementing Dual Spray MiniSpacer</tradeName>
    <deviceName>15mm OD/ID Dual Spray MiniSpacer with Counter Incrementing Actuator</deviceName>
    <manufacturerName>Thayer Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026197</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020302</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1543A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:53:28.310Z</lastUpdated>
  </row>
</eudamedExport>