<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817377021572</udiDi>
    <basicUdiDi>08173770211450008M</basicUdiDi>
    <tradeName>Perfect Fit 3D Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-13203-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021589</udiDi>
    <basicUdiDi>08173770211450008M</basicUdiDi>
    <tradeName>Perfect Fit 3D Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-13204-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021596</udiDi>
    <basicUdiDi>08173770211450008M</basicUdiDi>
    <tradeName>Perfect Fit 3D Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-13205-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021602</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14201-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021619</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14202-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021626</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14203-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021633</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14204-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021640</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14210-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021657</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14211-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021664</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14212-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021671</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14213-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021688</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14214-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021695</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14215-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021701</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14216-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021718</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14230-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021732</udiDi>
    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19-20000-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021749</udiDi>
    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-40315-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021756</udiDi>
    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-40316-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021763</udiDi>
    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-40306-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377021770</udiDi>
    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-40305-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:18.321Z</lastUpdated>
  </row>
</eudamedExport>