<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959001589</udiDi>
    <basicUdiDi>B-00606959001589</basicUdiDi>
    <tradeName>ComfortGel Blue Nasal Mask w/Headgear, Medium, INTL</tradeName>
    <deviceName>ComfortGel Blue / ProFile Lite Family</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1070065</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:49.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001572</udiDi>
    <basicUdiDi>B-00606959001572</basicUdiDi>
    <tradeName>ComfortGel Blue Nasal Mask w/Headgear, Large, INTL</tradeName>
    <deviceName>ComfortGel Blue / ProFile Lite Family</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1070064</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:48.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000736</udiDi>
    <basicUdiDi>B-30606959000736</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, S, INT – 5 PACK</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016697</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:05.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000743</udiDi>
    <basicUdiDi>B-30606959000743</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, M/L, INT</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016695</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:05.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007339</udiDi>
    <basicUdiDi>B-30606959007339</basicUdiDi>
    <tradeName>S AF531 SE NE W/CapStrap, SU, 10 Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1100396</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:05.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007346</udiDi>
    <basicUdiDi>B-30606959007346</basicUdiDi>
    <tradeName>M AF531 SE NE W/CapStrap, SU, 10 Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1100397</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:05.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007353</udiDi>
    <basicUdiDi>B-30606959007353</basicUdiDi>
    <tradeName>L AF531 SE NE W/CapStrap, SU, 10 Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1100438</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007834</udiDi>
    <basicUdiDi>B-30606959007834</basicUdiDi>
    <tradeName>EE Nebulizing Elbow Kit, 5 Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1072650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007858</udiDi>
    <basicUdiDi>B-30606959007858</basicUdiDi>
    <tradeName>Bronchoscopy Elbow (BE) RP Kit, 5 Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1072652</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008299</udiDi>
    <basicUdiDi>B-30606959008299</basicUdiDi>
    <tradeName>SE Nebulizing Elbow Kit, 5 Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1076754</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959024824</udiDi>
    <basicUdiDi>B-30606959024824</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, P, DOM/INT – 5 PACK</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016980</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042316</udiDi>
    <basicUdiDi>B-30606959042316</basicUdiDi>
    <tradeName>Circuit Filter DEP w/FEP Filter 10PK INTL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1065830</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042323</udiDi>
    <basicUdiDi>B-30606959042323</basicUdiDi>
    <tradeName>Single Use Filtered Exhalation Port Circuit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1065836</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042354</udiDi>
    <basicUdiDi>B-30606959042354</basicUdiDi>
    <tradeName>Disposable Invasive Circuits</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>582072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:17:04.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959000733</udiDi>
    <basicUdiDi>B-40606959000733</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, S, INT – 10 PACK</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016698</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:13:40.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959000740</udiDi>
    <basicUdiDi>B-40606959000740</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, M/L, INT – 10 PK</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016696</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:13:40.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959032215</udiDi>
    <basicUdiDi>B-40606959032215</basicUdiDi>
    <tradeName>Pro-Flow Nasal Cannula, Adult, 16”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pro-Tech Services, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002300</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1390</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:13:40.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032249</udiDi>
    <basicUdiDi>B-30606959032249</basicUdiDi>
    <tradeName>Pro-Flow Nasal Oral Cannula, Adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pro-Tech Services, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002300</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1295</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:46.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032256</udiDi>
    <basicUdiDi>B-30606959032256</basicUdiDi>
    <tradeName>Pro-Flow Plus Nasal Oral Cannula, Pediatric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pro-Tech Services, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002300</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1354</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:46.803Z</lastUpdated>
  </row>
</eudamedExport>