<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099967</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.992Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1112261</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730002415</udiDi>
    <basicUdiDi>B-00383730002415</basicUdiDi>
    <tradeName>InnoSpire Go UK/INT</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC NEBULISERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1126584</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730003870</udiDi>
    <basicUdiDi>B-00383730003870</basicUdiDi>
    <tradeName>InnoSpire Go Mask Adapter</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC NEBULISERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1125985</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730003962</udiDi>
    <basicUdiDi>B-00383730003962</basicUdiDi>
    <tradeName>InnoSpire Go Mouthpiece Assembly</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC NEBULISERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1128501</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730004051</udiDi>
    <basicUdiDi>B-00383730004051</basicUdiDi>
    <tradeName>InnoSpire Go EU2/ROW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC NEBULISERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1126560</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730004617</udiDi>
    <basicUdiDi>038373BM255XG</basicUdiDi>
    <tradeName>Oval 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HS757-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.801Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HS715-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060472442901</udiDi>
    <basicUdiDi>B-05060472442901</basicUdiDi>
    <tradeName>Tempus Pro Patient Monitor</tradeName>
    <deviceName>Tempus Pro Vital Signs Monitoring System</deviceName>
    <manufacturerName>Remote Diagnostic Technologies Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000002127</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>867420</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:24:12.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108080</udiDi>
    <basicUdiDi>B-00884838108080</basicUdiDi>
    <tradeName>E/M dS KNEE, 8CH 1.5T</tradeName>
    <deviceName>E/M dS KNEE, 8CH 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801728882</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:48.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108066</udiDi>
    <basicUdiDi>B-00884838108066</basicUdiDi>
    <tradeName>FLEX, SMALL, 3T, IRF</tradeName>
    <deviceName>FLEX, SMALL, 3T, IRF</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729982</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:47.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108042</udiDi>
    <basicUdiDi>B-00884838108042</basicUdiDi>
    <tradeName>FLEX, MEDIUM, 3T, IRF</tradeName>
    <deviceName>FLEX, MEDIUM, 3T, IRF</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729962</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:45.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108059</udiDi>
    <basicUdiDi>B-00884838108059</basicUdiDi>
    <tradeName>DS FLEX S COIL, 1.5T</tradeName>
    <deviceName>DS FLEX S COIL, 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729972</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:43.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108028</udiDi>
    <basicUdiDi>B-00884838108028</basicUdiDi>
    <tradeName>dS FLEX-L 3.0T</tradeName>
    <deviceName>dS FLEX-L 3.0T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729942</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:41.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108035</udiDi>
    <basicUdiDi>B-00884838108035</basicUdiDi>
    <tradeName>DS FLEX M 1.5T</tradeName>
    <deviceName>DS FLEX M 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729952</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:40.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838108011</udiDi>
    <basicUdiDi>B-00884838108011</basicUdiDi>
    <tradeName>dS FLEX-L 1.5T</tradeName>
    <deviceName>dS FLEX-L 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729932</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:25.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838107991</udiDi>
    <basicUdiDi>B-00884838107991</basicUdiDi>
    <tradeName>MICROSCOPY 47MM COIL, INGENIA 3.0T</tradeName>
    <deviceName>MICROSCOPY 47MM COIL, INGENIA 3.0T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801794482</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:24.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838107984</udiDi>
    <basicUdiDi>B-00884838107984</basicUdiDi>
    <tradeName>MICROSCOPY 23MM COIL, INGENIA 3.0T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801730012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:23.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838107977</udiDi>
    <basicUdiDi>B-00884838107977</basicUdiDi>
    <tradeName>MICROSCOPY 23MM COIL, INGENIA 1.5T</tradeName>
    <deviceName>MICROSCOPY 23MM COIL, INGENIA 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801795042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:20.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838107960</udiDi>
    <basicUdiDi>B-00884838107960</basicUdiDi>
    <tradeName>MICROSCOPY 47MM COIL, INGENIA 1.5T</tradeName>
    <deviceName>MICROSCOPY 47MM COIL, INGENIA 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>459801729992</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:10:19.182Z</lastUpdated>
  </row>
</eudamedExport>