<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00087453800364</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 2, Latex, 1.5M - 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>091191949</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800371</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 3, Latex, 1.5M - 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>091191956</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800388</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, Latex, 1.5M - 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>091191964</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800395</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 5, Latex, 1.5M - 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>091191972</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800401</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 1, Non-Latex, 1.5M - 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>091524909</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800418</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 2, Non-Latex, 1.5M - 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>091181858</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800425</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 3, Non-Latex, 1.5M - 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>091191980</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800432</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, Non-Latex, 1.5M - 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>091191998</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800449</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 5, Non-Latex, 1.5M - 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>091192004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800456</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 1, 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>091259563</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800463</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 2, Latex, 25M - 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>091259639</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800470</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 3, 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>091259654</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800487</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, 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>091259720</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800494</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 5, 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>091259753</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800500</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>091337344</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800517</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 2, Non-Latex, 25M - 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>091337351</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800524</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>091337369</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800531</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>091337377</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800548</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>091337385</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:51.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800555</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan ExercisRolyan Exercise Band, Level 1, Non-Latex, 50M - Yellowe 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>091338946</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.985Z</lastUpdated>
  </row>
</eudamedExport>