<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810075280128</udiDi>
    <basicUdiDi>081007528925MBRGM</basicUdiDi>
    <tradeName>Tray Topper | Regular</tradeName>
    <deviceName>Tray Topper | Regular</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925.MBR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:20.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280111</udiDi>
    <basicUdiDi>081007528925MBSGP</basicUdiDi>
    <tradeName>Tray Topper | Small</tradeName>
    <deviceName>Tray Topper | Small</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925.MBS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:19.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280104</udiDi>
    <basicUdiDi>0810075281091013CIYC</basicUdiDi>
    <tradeName>Troop | 3-Set</tradeName>
    <deviceName>Troop | 3-Set</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-910-13-C-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:18.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280098</udiDi>
    <basicUdiDi>0810075281091012CIY7</basicUdiDi>
    <tradeName>Troop | 2-Set</tradeName>
    <deviceName>Troop | 2-Set</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-910-12-C-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:14.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280081</udiDi>
    <basicUdiDi>0810075281091001CWD</basicUdiDi>
    <tradeName>Troop | Standard System</tradeName>
    <deviceName>Troop | Standard System</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-910-01-C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:13.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280074</udiDi>
    <basicUdiDi>0810075281091006CWU</basicUdiDi>
    <tradeName>Troop | Complete System</tradeName>
    <deviceName>Troop | Complete System</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-910-06-C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:12.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280050</udiDi>
    <basicUdiDi>0810075281091007CWX</basicUdiDi>
    <tradeName>Troop | Arm Board Pad | Set of 2</tradeName>
    <deviceName>Troop | Arm Board Pad | Set of 2</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-910-07-C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:12.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280029</udiDi>
    <basicUdiDi>0810075281091107CX6</basicUdiDi>
    <tradeName>Troop | Elevation Pillow Addition - Coated</tradeName>
    <deviceName>Troop | Elevation Pillow Addition - Coated</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-911-07-C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:08.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810075280012</udiDi>
    <basicUdiDi>0810075281091106CX3</basicUdiDi>
    <tradeName>Troop | Elevation Pillow - Coated</tradeName>
    <deviceName>Troop | Elevation Pillow - Coated</deviceName>
    <manufacturerName>Bone Foam, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035043</manufacturerSrn>
    <authorisedRepresentativeName>Bone Foam B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000035735</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-911-06-C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:48:07.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810062780259</udiDi>
    <basicUdiDi>081006278SC001U5</basicUdiDi>
    <tradeName>00810062780259</tradeName>
    <deviceName>Seat cushion</deviceName>
    <manufacturerName>Upper Echelon Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000048387</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080399</emdnCode>
    <emdnDescription>MEDICAL CUSHIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:41:06.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756005883</udiDi>
    <basicUdiDi>0749756074T07BL</basicUdiDi>
    <tradeName>Wheelchair Cushion</tradeName>
    <deviceName>Wheelchair Cushion</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080399</emdnCode>
    <emdnDescription>MEDICAL CUSHIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M10-084</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:58:52.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>07072423002407</udiDi>
    <basicUdiDi>07072423002391DL</basicUdiDi>
    <tradeName>07072423002407</tradeName>
    <deviceName>SIT Comfort High</deviceName>
    <manufacturerName>Bedtime AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08030102</emdnCode>
    <emdnDescription>NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIT Comfort High</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:44:32.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>07072423002346</udiDi>
    <basicUdiDi>07072423002339DJ</basicUdiDi>
    <tradeName>07072423002346</tradeName>
    <deviceName>SIT Comfort Low</deviceName>
    <manufacturerName>Bedtime AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08030102</emdnCode>
    <emdnDescription>NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIT Comfort Low</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:44:28.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>07072423002384</udiDi>
    <basicUdiDi>07072423002377DS</basicUdiDi>
    <tradeName>07072423002384</tradeName>
    <deviceName>SIT Cube High</deviceName>
    <manufacturerName>Bedtime AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08030102</emdnCode>
    <emdnDescription>NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIT Cube High</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:44:26.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>07072423002360</udiDi>
    <basicUdiDi>07072423002353DC</basicUdiDi>
    <tradeName>07072423002360</tradeName>
    <deviceName>SIT Cube Low</deviceName>
    <manufacturerName>Bedtime AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08030102</emdnCode>
    <emdnDescription>NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIT Cube Low</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:44:26.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979280510018</udiDi>
    <basicUdiDi>0697928051pilQ6</basicUdiDi>
    <tradeName>Polyurethane Foam pillow cushion</tradeName>
    <deviceName>Polyurethane Foam pillow cushion</deviceName>
    <manufacturerName>NingBo KingWorth Global Imp. &amp; Exp. Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050432</manufacturerSrn>
    <authorisedRepresentativeName>REP Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025090</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080399</emdnCode>
    <emdnDescription>MEDICAL CUSHIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Polyurethane Foam pillow cushion</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:17:04.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00644812055942</udiDi>
    <basicUdiDi>0644812CUSHIONXA</basicUdiDi>
    <tradeName>00644812055942</tradeName>
    <deviceName>WELLPRIME PAINFREE CUSHION</deviceName>
    <manufacturerName>Shanghai Industex RO</manufacturerName>
    <manufacturerSrn>CN-MF-000035392</manufacturerSrn>
    <authorisedRepresentativeName>INDUSTEX S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000013315</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080399</emdnCode>
    <emdnDescription>MEDICAL CUSHIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMDVACIND0028</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:07:09.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00644812050305</udiDi>
    <basicUdiDi>0644812PILLOWV4</basicUdiDi>
    <tradeName>00644812050305</tradeName>
    <deviceName>RESTFORM LEG PILLOW</deviceName>
    <manufacturerName>Shanghai Industex RO</manufacturerName>
    <manufacturerSrn>CN-MF-000035392</manufacturerSrn>
    <authorisedRepresentativeName>INDUSTEX S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000013315</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080399</emdnCode>
    <emdnDescription>MEDICAL CUSHIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMDVACIND0025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:07:08.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628204113038</udiDi>
    <basicUdiDi>0628204THERAPEUTICAKL</basicUdiDi>
    <tradeName>Therapeutica Sleeping Pillow</tradeName>
    <deviceName>Therapeutica Sleeping Pillow</deviceName>
    <manufacturerName>Core Products International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008471</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080399</emdnCode>
    <emdnDescription>MEDICAL CUSHIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOM-130-LRG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:06:06.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>04820183234599</udiDi>
    <basicUdiDi>018323PMP605VR</basicUdiDi>
    <tradeName>Poduszka ortopedyczna (Ortopedio by Synoptis)</tradeName>
    <deviceName>Orthopedic pillow</deviceName>
    <manufacturerName>PRIVATE ENTERPRISE "REMED"</manufacturerName>
    <manufacturerSrn>UA-MF-000056451</manufacturerSrn>
    <authorisedRepresentativeName>GSI-CERT German Scientific Institute for Quality, Testing and Certification GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000056188</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04820183234599</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:47:29.850Z</lastUpdated>
  </row>
</eudamedExport>