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    <tradeName>Scala Patient Recorder with WiFi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:08:14.803Z</lastUpdated>
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    <udiDi>04251978600938</udiDi>
    <basicUdiDi>4251978601003ZW</basicUdiDi>
    <tradeName>SleepDoc Porti 10 PG Patient Recorder w/o WiFi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:08:14.735Z</lastUpdated>
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    <udiDi>04251978600310</udiDi>
    <basicUdiDi>4251978601003ZW</basicUdiDi>
    <tradeName>SleepDoc Porti 9 Patient Recorder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>929000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T00:19:55.922Z</lastUpdated>
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    <udiDi>04251978600891</udiDi>
    <basicUdiDi>4251978601003ZW</basicUdiDi>
    <tradeName>PolyX Patient Recorder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>929012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T00:19:55.884Z</lastUpdated>
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    <udiDi>05404036000013</udiDi>
    <basicUdiDi>54040360DREAMSCAN2DQ</basicUdiDi>
    <tradeName>05404036000013</tradeName>
    <deviceName>DREAMSCAN 2</deviceName>
    <manufacturerName>Medical Data Technology</manufacturerName>
    <manufacturerSrn>BE-MF-000000788</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DREAMSCAN2 - DRSC2 revB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:48:00.964Z</lastUpdated>
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  <row>
    <udiDi>04251978600389</udiDi>
    <basicUdiDi>4251978601003ZW</basicUdiDi>
    <tradeName>Samoa lite Patient Recorder</tradeName>
    <deviceName>Polygraphy devices</deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>929009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:14:35.694Z</lastUpdated>
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  <row>
    <udiDi>03700659400899</udiDi>
    <basicUdiDi>3700659416709N</basicUdiDi>
    <tradeName>PolyLink</tradeName>
    <deviceName>PolyLink</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116700</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:56.065Z</lastUpdated>
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    <udiDi>06430035221134</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro RIP Belt Short (50pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S0000020363</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.419Z</lastUpdated>
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    <udiDi>06430035221141</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro RIP Belt Long</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S0000020352</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.397Z</lastUpdated>
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    <udiDi>06430035221158</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro RIP Belt Long (50pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S0000020368</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.377Z</lastUpdated>
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    <udiDi>06430035221165</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro 1 RIP Belt Patch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9305402</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.351Z</lastUpdated>
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    <udiDi>06430035221172</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro 1 RIP Belt Patch (30pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9404777</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.328Z</lastUpdated>
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    <udiDi>06430035221189</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro 2 RIP Belts Patch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9305403</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.303Z</lastUpdated>
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    <udiDi>06430035221196</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro 2 RIP Belts Patch (40pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9404778</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.261Z</lastUpdated>
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    <udiDi>06430035221202</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro ECG Adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9305576</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.243Z</lastUpdated>
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    <udiDi>06430035221219</udiDi>
    <basicUdiDi>643003522RespiroAccLK</basicUdiDi>
    <tradeName>Respiro ECG Adapter (40pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z129012</emdnCode>
    <emdnDescription>MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9404781</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:08.229Z</lastUpdated>
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