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    <udiDi>00606959039728</udiDi>
    <basicUdiDi>B-00606959039728</basicUdiDi>
    <tradeName>Alice NightOne, Nonin SpO2 Cable</tradeName>
    <deviceName>Alice NightOne System</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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1119823</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:33.895Z</lastUpdated>
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  <row>
    <udiDi>00606959039025</udiDi>
    <basicUdiDi>B-00606959039025</basicUdiDi>
    <tradeName>Alice PDx Core System without Sensors, INTL</tradeName>
    <deviceName>Alice PDx System</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>1058370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:32.293Z</lastUpdated>
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  <row>
    <udiDi>00606959033245</udiDi>
    <basicUdiDi>B-00606959033245</basicUdiDi>
    <tradeName>Alice 6 Therapy Circuit Interface Kit</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>1082653</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:06:10.553Z</lastUpdated>
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    <udiDi>00606959027091</udiDi>
    <basicUdiDi>B-00606959027091</basicUdiDi>
    <tradeName>NK Piezo Sensor</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>P1496</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:52.057Z</lastUpdated>
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  <row>
    <udiDi>00606959020689</udiDi>
    <basicUdiDi>B-00606959020689</basicUdiDi>
    <tradeName>Alice PDx Unit Only, Warranty Exchange, INTL</tradeName>
    <deviceName>Alice PDx System</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>1057624</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:37.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020559</udiDi>
    <basicUdiDi>B-00606959020559</basicUdiDi>
    <tradeName>Alice PDx ExG Yoke, INTL</tradeName>
    <deviceName>Alice PDx System</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>1048415</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:22.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020481</udiDi>
    <basicUdiDi>B-00606959020481</basicUdiDi>
    <tradeName>Alice PDx Sleep Diagnostic System, INTL</tradeName>
    <deviceName>Alice PDx System</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>1043844</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:15.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020450</udiDi>
    <basicUdiDi>B-00606959020450</basicUdiDi>
    <tradeName>Alice PDx ECG Yoke, INTL</tradeName>
    <deviceName>Alice PDx System</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>1040810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:14.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020375</udiDi>
    <basicUdiDi>B-00606959020375</basicUdiDi>
    <tradeName>Alice 5 International Headbox</tradeName>
    <deviceName>Alice 5 and Alice LE Polysomnography Systems</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>1017231</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:10.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020368</udiDi>
    <basicUdiDi>B-00606959020368</basicUdiDi>
    <tradeName>Alice 5 International Base Unit Only</tradeName>
    <deviceName>Alice 5 and Alice LE Polysomnography Systems</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>1017230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:09.333Z</lastUpdated>
  </row>
  <row>
    <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>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>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>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>
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