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<eudamedExport entity="devices">
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    <basicUdiDi>0850067173OPALY3</basicUdiDi>
    <tradeName>Opal V2C</tradeName>
    <deviceName>Opal V2C System</deviceName>
    <manufacturerName>APDM WEARABLE TECHNOLOGIES, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000044036</manufacturerSrn>
    <authorisedRepresentativeName>eResearchTechnology GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Opal V2C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:31:01.728Z</lastUpdated>
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    <udiDi>00606959409811</udiDi>
    <basicUdiDi>B-00606959409811</basicUdiDi>
    <tradeName>Actiwatch Spectrum Communication Dock System Recertified</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1048093</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:04.066Z</lastUpdated>
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    <udiDi>00606959409804</udiDi>
    <basicUdiDi>B-00606959409804</basicUdiDi>
    <tradeName>Actiwatch 2 Communication Dock System Recertified</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1048092</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:03.267Z</lastUpdated>
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    <udiDi>00606959409798</udiDi>
    <basicUdiDi>B-00606959409798</basicUdiDi>
    <tradeName>Actiwatch Spectrum Device Recertified</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>MDD</legislation>
    <emdnCode>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1048091</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:02.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409781</udiDi>
    <basicUdiDi>B-00606959409781</basicUdiDi>
    <tradeName>Actiwatch 2 Device Recertified</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1048090</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:01.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409644</udiDi>
    <basicUdiDi>B-00606959409644</basicUdiDi>
    <tradeName>Actiwatch Spectrum Communication Dock System Rental</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1048093</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:56.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409637</udiDi>
    <basicUdiDi>B-00606959409637</basicUdiDi>
    <tradeName>Actiwatch 2 Communication Dock System Rental</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1048092</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:55.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409620</udiDi>
    <basicUdiDi>B-00606959409620</basicUdiDi>
    <tradeName>Actiwatch Spectrum Device Rental</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1048091</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:50.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409613</udiDi>
    <basicUdiDi>B-00606959409613</basicUdiDi>
    <tradeName>Actiwatch 2 Device-Rental</tradeName>
    <deviceName>Actiwatch 2 and Actiwatch Spectrum</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1048090</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:49.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409446</udiDi>
    <basicUdiDi>B-00606959409446</basicUdiDi>
    <tradeName>Actical-Recertified</tradeName>
    <deviceName>Actical</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1081737</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:48.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959409392</udiDi>
    <basicUdiDi>B-00606959409392</basicUdiDi>
    <tradeName>Actical-Rental</tradeName>
    <deviceName>Actical</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1081737</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:48.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042100</udiDi>
    <basicUdiDi>B-00606959042100</basicUdiDi>
    <tradeName>Actiwatch Spectrum Communication Dock</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1046978</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:53.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042056</udiDi>
    <basicUdiDi>B-00606959042056</basicUdiDi>
    <tradeName>Actiwatch 2 Communication Dock</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1046977</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:53.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021013</udiDi>
    <basicUdiDi>B-00606959021013</basicUdiDi>
    <tradeName>Actical Software</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1081738</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:44.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020542</udiDi>
    <basicUdiDi>B-00606959020542</basicUdiDi>
    <tradeName>Actiwatch Spectrum Communication Dock System</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1048093</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:21.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959020511</udiDi>
    <basicUdiDi>B-00606959020511</basicUdiDi>
    <tradeName>ActiWatch Spectrum System</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1046964</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:17.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959003903</udiDi>
    <basicUdiDi>B-00606959003903</basicUdiDi>
    <tradeName>Actiwatch 2 Communication Dock System</tradeName>
    <deviceName>Actiwatch 2 and Actiwatch Spectrum</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1048092</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:03.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959003897</udiDi>
    <basicUdiDi>B-00606959003897</basicUdiDi>
    <tradeName>Actiwatch 2 Device</tradeName>
    <deviceName>Actiwatch 2 and Actiwatch Spectrum</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1048090</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:02.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959003842</udiDi>
    <basicUdiDi>B-00606959003842</basicUdiDi>
    <tradeName>Actiwatch 2 System</tradeName>
    <deviceName>Actiwatch 2 and Actiwatch Spectrum</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1044809</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:01.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>09359011000006</udiDi>
    <basicUdiDi>93590110GKC20XXEH</basicUdiDi>
    <tradeName>PKG System</tradeName>
    <deviceName>The Parkinsons KinetiGraph (PKG) System</deviceName>
    <manufacturerName>GKC Manufacturing Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000021150</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PKG System</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:08:22.458Z</lastUpdated>
  </row>
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