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<eudamedExport entity="devices">
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    <udiDi>00606959020245</udiDi>
    <basicUdiDi>B-00606959020245</basicUdiDi>
    <tradeName>Alice LE System 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>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1002288</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:04.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015289</udiDi>
    <basicUdiDi>B-00606959015289</basicUdiDi>
    <tradeName>CoughAssist, Adapter, 22mm x 15mm</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>1044191</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:02.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015166</udiDi>
    <basicUdiDi>B-00606959015166</basicUdiDi>
    <tradeName>Whisper Swivel II Packaged</tradeName>
    <deviceName>Whisper Swivel II Packaged</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>332113</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:02.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014992</udiDi>
    <basicUdiDi>B-00606959014992</basicUdiDi>
    <tradeName>AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL</tradeName>
    <deviceName>Amara, Amara Gel 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>Piyasada</deviceStatus>
    <reference>1090228</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:00.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014985</udiDi>
    <basicUdiDi>B-00606959014985</basicUdiDi>
    <tradeName>AMARA MASK W/ RS FRAME AND HEADGEAR, MEDIUM, INTL</tradeName>
    <deviceName>Amara, Amara Gel 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>Piyasada</deviceStatus>
    <reference>1090225</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:58.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014978</udiDi>
    <basicUdiDi>B-00606959014978</basicUdiDi>
    <tradeName>AMARA MASK W/ RS FRAME AND RS HEADGEAR, SMALL, INTL</tradeName>
    <deviceName>Amara, Amara Gel 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>Piyasada</deviceStatus>
    <reference>1090221</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:56.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014251</udiDi>
    <basicUdiDi>B-00606959014251</basicUdiDi>
    <tradeName>System One Heated Tube Humidfier 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>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IN6T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:55.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014244</udiDi>
    <basicUdiDi>B-00606959014244</basicUdiDi>
    <tradeName>System One Heated Humidifier 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>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IN6H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:54.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010833</udiDi>
    <basicUdiDi>B-00606959010833</basicUdiDi>
    <tradeName>Piezo Sensor 1.5" (3.81 cm)</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>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1460</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:51.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010826</udiDi>
    <basicUdiDi>B-00606959010826</basicUdiDi>
    <tradeName>Velcro Strap P 1" (2.54 cm) Kit</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>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1448</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:50.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010796</udiDi>
    <basicUdiDi>B-00606959010796</basicUdiDi>
    <tradeName>Two Channel Plus Kit, Pediatric 1" (2.54 cm)</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>MDD</legislation>
    <emdnCode>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1464R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:49.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010789</udiDi>
    <basicUdiDi>B-00606959010789</basicUdiDi>
    <tradeName>PIEZO 1 CH PEDIATRIC KIT</tradeName>
    <deviceName>ProTech Respiratory Effort Sensors</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1462R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:47.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010581</udiDi>
    <basicUdiDi>B-00606959010581</basicUdiDi>
    <tradeName>zRIP Cable Abdomen, QDC</tradeName>
    <deviceName>Pro-Tech Accessories</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1176</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:45.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010499</udiDi>
    <basicUdiDi>B-00606959010499</basicUdiDi>
    <tradeName>zRIP DuraBelt Kit, Ped., QDC</tradeName>
    <deviceName>ProTech Respiratory Effort Sensors</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1075967</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:43.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959010482</udiDi>
    <basicUdiDi>B-00606959010482</basicUdiDi>
    <tradeName>zRIP DuraBelt Kit, Adult, QDC</tradeName>
    <deviceName>ProTech Respiratory Effort Sensors</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1075968</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:42.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009875</udiDi>
    <basicUdiDi>B-00606959009875</basicUdiDi>
    <tradeName>Cable, High Level Output, 3/32 (2.381 mm) Male Phone connector</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>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1080</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:41.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009929</udiDi>
    <basicUdiDi>B-00606959009929</basicUdiDi>
    <tradeName>Cable, Low Level Output, 3/32" (2.381 mm) Male Phone Connector</tradeName>
    <deviceName>Pro-Tech Accessories</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1077</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:38.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009264</udiDi>
    <basicUdiDi>B-00606959009264</basicUdiDi>
    <tradeName>Amara View Mask with Headgear, Medium, INTL</tradeName>
    <deviceName>Amara View Minimal Contact</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>Piyasada</deviceStatus>
    <reference>1090663</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:37.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009790</udiDi>
    <basicUdiDi>B-00606959009790</basicUdiDi>
    <tradeName>CPAP Titration Kit, Alice PDx</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1391</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:36.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009189</udiDi>
    <basicUdiDi>B-00606959009189</basicUdiDi>
    <tradeName>Amara View Mask without Headgear, Large</tradeName>
    <deviceName>Amara View Minimal Contact</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>Piyasada</deviceStatus>
    <reference>1090614</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:21.249Z</lastUpdated>
  </row>
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