<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05028318901388</udiDi>
    <basicUdiDi>00874530000000000000002XK</basicUdiDi>
    <tradeName>Rolyan Exercise Tubing, Level 4, Latex, 30.5M - Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-METTUB100BLU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028318901401</udiDi>
    <basicUdiDi>00874530000000000000002XK</basicUdiDi>
    <tradeName>Rolyan Exercise Tubing, Level 5, Latex, 30.5M - Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-METTUB100BLK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319065188</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 1, Non-Latex, 25M - Yellow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-METBAND25MYEL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319065201</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 3, Non-Latex, 25M - Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-METBAND25MGRN</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319065218</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, Non-Latex, 25M - Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-METBAND25MBLU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319065225</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 5, Non-Latex, 25M - Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-METBAND25MBLK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319066680</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 1, Non-Latex, 5M - Yellow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338847</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319066697</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 2, Non-Latex, 5M - Red</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338854</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319066758</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, Non-Latex, 5M - Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338912</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319066765</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, Non-Latex, 5M - Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338920</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>05028319066772</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 5, Non-Latex, 5M - Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Hygenic Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003317</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338938</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:32.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593037</udiDi>
    <basicUdiDi>3770024593IVS33B</basicUdiDi>
    <tradeName>IVS3 (with IT cord + QWERTY US keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS3 - ITA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593075</udiDi>
    <basicUdiDi>3770024593IVS33B</basicUdiDi>
    <tradeName>IVS3 (with EU cord + QWERTY BE keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS3 - BEL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593082</udiDi>
    <basicUdiDi>3770024593IVS33B</basicUdiDi>
    <tradeName>IVS3 (EU cord + QWERTY ES keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS3 - ESP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593112</udiDi>
    <basicUdiDi>3770024593IVS33B</basicUdiDi>
    <tradeName>IVS3 (with EU cord and QWERTZ-DE Keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS3 (with EU cord and QWERTZ-DE Keyboard)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593129</udiDi>
    <basicUdiDi>3770024593IVS33B</basicUdiDi>
    <tradeName>IVS3 (EU cord + QWERTY NORDIC keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS3 - NORDIC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593204</udiDi>
    <basicUdiDi>3770024593IVS43D</basicUdiDi>
    <tradeName>IVS4 (with EU cord and QWERTY-US keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS4 - EUR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593211</udiDi>
    <basicUdiDi>3770024593IVS43D</basicUdiDi>
    <tradeName>IVS4 (with EU cord and QWERTZ-DE keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS4 - DEU + AUT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593266</udiDi>
    <basicUdiDi>3770024593IVS33B</basicUdiDi>
    <tradeName>IVS3 (with EU cord + QWERTY US keybord)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS3 - EUR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024593303</udiDi>
    <basicUdiDi>3770024593IVS43D</basicUdiDi>
    <tradeName>IVS4 (with IT cord and QWERTY-US keyboard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DESSINTEY</manufacturerName>
    <manufacturerSrn>FR-MF-000009697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0504</emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVS4 - ITA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.342Z</lastUpdated>
  </row>
</eudamedExport>