<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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></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></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></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></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></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></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></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></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></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></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>
  <row>
    <udiDi>00087453800562</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 2, Non-Latex, 50M - 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></emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338953</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800579</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 3, Non-Latex, 50M - 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></emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091338961</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800586</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 4, Non-Latex, 50M - 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></emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091339027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800593</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Rolyan Exercise Band, Level 5, Non-Latex, 50M - 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></emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091339035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800661</udiDi>
    <basicUdiDi>00874530000000000000002XK</basicUdiDi>
    <tradeName>Rolyan Figure 8 Exerciser, X-Extra Firm - 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-PHYFIG8BLK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800678</udiDi>
    <basicUdiDi>00874530000000000000002XK</basicUdiDi>
    <tradeName>Rolyan Figure 8 Exerciser, Firm - Green</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-PHYFIG8GRN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453800685</udiDi>
    <basicUdiDi>00874530000000000000002XK</basicUdiDi>
    <tradeName>Rolyan O-Ring Exerciser, X-Extra Firm - 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THA-PHYORINGBLK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453997675</udiDi>
    <basicUdiDi>00874530000000000000023XT</basicUdiDi>
    <tradeName>Hygenic FR Framed Dental Dam Non-Latex, Purple, 1/PK Sample</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></emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15615</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453999853</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Theraband, 8’3” (2.5m), Leprello Pack - 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></emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20264L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>00087453999860</udiDi>
    <basicUdiDi>00874530000000000000001XH</basicUdiDi>
    <tradeName>Theraband, 8’3” (2.5m), Leprello Pack - 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></emdnCode>
    <emdnDescription>ARMS, TORSO AND LEGS RE-EDUCATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20255L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:50.757Z</lastUpdated>
  </row>
</eudamedExport>