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<eudamedExport entity="devices">
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    <basicUdiDi>B-00606959419940</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, UK</tradeName>
    <deviceName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RPL2EU01UK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:18.588Z</lastUpdated>
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  <row>
    <udiDi>00606959419933</udiDi>
    <basicUdiDi>B-00606959419933</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, NL</tradeName>
    <deviceName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RPL2EU01NL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:17.783Z</lastUpdated>
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  <row>
    <udiDi>00606959419629</udiDi>
    <basicUdiDi>B-00606959419629</basicUdiDi>
    <tradeName>Philips NightBalance Mobile App, Android</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1142207</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:10.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419612</udiDi>
    <basicUdiDi>B-00606959419612</basicUdiDi>
    <tradeName>Philips NightBalance Mobile App, iOS</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1142206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:08.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060357</udiDi>
    <basicUdiDi>B-00606959060357</basicUdiDi>
    <tradeName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1145658</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:11:54.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059580</udiDi>
    <basicUdiDi>B-00606959059580</basicUdiDi>
    <tradeName>Philips NightBalance, IB</tradeName>
    <deviceName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>L2EU01IB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:11:52.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959057517</udiDi>
    <basicUdiDi>B-00606959057517</basicUdiDi>
    <tradeName>Philips NightBalance DK</tradeName>
    <deviceName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>L2EU01DK</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:11:14.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054639</udiDi>
    <basicUdiDi>B-00606959054639</basicUdiDi>
    <tradeName>Philips NightBalance, DE</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>L2EU01DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:39.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054615</udiDi>
    <basicUdiDi>B-00606959054615</basicUdiDi>
    <tradeName>Philips NightBalance UK</tradeName>
    <deviceName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>L2EU01UK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:35.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054622</udiDi>
    <basicUdiDi>B-00606959054622</basicUdiDi>
    <tradeName>Philips NightBalance, FR</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>L2EU01FR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:34.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054592</udiDi>
    <basicUdiDi>B-00606959054592</basicUdiDi>
    <tradeName>Philips NightBalance NL</tradeName>
    <deviceName>NightBalance</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>L2EU01NL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:20.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042551</udiDi>
    <basicUdiDi>B-00606959042551</basicUdiDi>
    <tradeName>Philips Basic Kit, PerformaTrak SE, 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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1074050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:09:00.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>09180004130147</udiDi>
    <basicUdiDi>918000413NAMG01YJ</basicUdiDi>
    <tradeName>09180004130147</tradeName>
    <deviceName>Brainhero App</deviceName>
    <manufacturerName>Brainhero GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000022440</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062492</emdnCode>
    <emdnDescription>BIOFEEDBACK INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BrainheroApp</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:03:40.418Z</lastUpdated>
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  <row>
    <udiDi>08720299476301</udiDi>
    <basicUdiDi>87202994763Anika01-1.78A</basicUdiDi>
    <tradeName>Anika</tradeName>
    <deviceName>The Anika Complex for Musculoskeletal System Rehabilitation with Biofeedback</deviceName>
    <manufacturerName>OOO NPF "Rehabilitation technologies"</manufacturerName>
    <manufacturerSrn>RU-MF-000001266</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:48:15.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719481550110</udiDi>
    <basicUdiDi>871948155010NX1038A</basicUdiDi>
    <tradeName>NeXus | 10 MK3 Medical</tradeName>
    <deviceName>NeXus | 10 MK3</deviceName>
    <manufacturerName>Mind Media Europe B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001576</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062499</emdnCode>
    <emdnDescription>BIOFEEDBACK INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70-0008-1001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:37:25.340Z</lastUpdated>
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    <udiDi>08056977850096</udiDi>
    <basicUdiDi>805697785NODALGDYN004PN</basicUdiDi>
    <tradeName>NOD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OT Bioelettronica srl</manufacturerName>
    <manufacturerSrn>IT-MF-000033348</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OT0110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:23:10.945Z</lastUpdated>
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    <udiDi>07540191000470</udiDi>
    <basicUdiDi>7540191000479H</basicUdiDi>
    <tradeName>eVu TPS</tradeName>
    <deviceName>eVu TPS System</deviceName>
    <manufacturerName>Thought Technology, Ltd.</manufacturerName>
    <manufacturerSrn>CA-MF-000024010</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA4500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:50.712Z</lastUpdated>
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    <udiDi>07540191000449</udiDi>
    <basicUdiDi>7540191000449B</basicUdiDi>
    <tradeName>BioGraph Infiniti</tradeName>
    <deviceName>BioGraph Infiniti</deviceName>
    <manufacturerName>Thought Technology, Ltd.</manufacturerName>
    <manufacturerSrn>CA-MF-000024010</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062492</emdnCode>
    <emdnDescription>BIOFEEDBACK INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA7900</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:49.889Z</lastUpdated>
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    <udiDi>07540191000029</udiDi>
    <basicUdiDi>7540191000038V</basicUdiDi>
    <tradeName>ProComp 2;ProComp Infiniti;ProComp 5 Infiniti;FlexComp Infiniti;TT-pIR Sensor/TT-pIR System;TT AV-Sync/TT AV-Sync Sensor;EEG-Z3/EEG-Z3 Sensor;EEG-Z;EKG Flex/Pro;BVP-Flex Pro;SC- Flex/Pro;Respiration Sensor;</tradeName>
    <deviceName>ProComp family</deviceName>
    <manufacturerName>Thought Technology, Ltd.</manufacturerName>
    <manufacturerSrn>CA-MF-000024010</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA7400; SA7500; SA7525; SA7550; SA2600/T2600; SA7670/T7670; SA7680Z/T7680; SA9305Z; SA9306M; SA9308M; SA9309M; SA9311M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:29.028Z</lastUpdated>
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    <udiDi>06975430610003</udiDi>
    <basicUdiDi>697543061KM-0019S</basicUdiDi>
    <tradeName>Disposable Index Sensor</tradeName>
    <deviceName>Disposable Index Sensor</deviceName>
    <manufacturerName>Hunan Kemai Technology Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000023417</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062499</emdnCode>
    <emdnDescription>BIOFEEDBACK INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:59:23.541Z</lastUpdated>
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</eudamedExport>