<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00087179731515</udiDi>
    <basicUdiDi>871797315LTTP-002OTGV</basicUdiDi>
    <tradeName>OS160</tradeName>
    <deviceName>Turbocast Ortho (NS)</deviceName>
    <manufacturerName>Ttape Company</manufacturerName>
    <manufacturerSrn>NL-MF-000003944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TTape manual</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:22:38.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436627662321</udiDi>
    <basicUdiDi>8437023092LEC001WE</basicUdiDi>
    <tradeName>LECKKO</tradeName>
    <deviceName>NUBOLO DYNAMIC</deviceName>
    <manufacturerName>OKM Quimica Ortopedica, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000005168</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LB01LG1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:10:59.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436627660013</udiDi>
    <basicUdiDi>8437023092SYS001BQ</basicUdiDi>
    <tradeName>OKMSYSTEM</tradeName>
    <deviceName>NUBOLO STATIC</deviceName>
    <manufacturerName>OKM Quimica Ortopedica, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000005168</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC02GL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:10:58.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435194403078</udiDi>
    <basicUdiDi>84351944FTFI03MT</basicUdiDi>
    <tradeName>FIJACION moldeable ADOLESCENTE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>2miil artesania sanitaria sl</manufacturerName>
    <manufacturerSrn>ES-MF-000009569</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:45:05.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>16979407960013</udiDi>
    <basicUdiDi>697940796TP-01SG</basicUdiDi>
    <tradeName>Alien Medical</tradeName>
    <deviceName>Thermoplastic Splint</deviceName>
    <manufacturerName>Shenzhen Alien Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051146</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:40:38.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974423592302</udiDi>
    <basicUdiDi>697442359ICBS3</basicUdiDi>
    <tradeName>06974423592302</tradeName>
    <deviceName>Instant Cold Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-IC-B 230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:03.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974423592005</udiDi>
    <basicUdiDi>697442359ICARZ</basicUdiDi>
    <tradeName>06974423592005</tradeName>
    <deviceName>Instant Cold Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-IC-B 200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:02.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974423590049</udiDi>
    <basicUdiDi>697442359RPAUM</basicUdiDi>
    <tradeName>06974423590049</tradeName>
    <deviceName>Cold/Hot Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-RP-CH</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:00.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838567</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-WRIST-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838581</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-THUMB-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838604</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-KNEE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977839786</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Woodcast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1580-BLACK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838628</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-HEEL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838611</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-ANKLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838574</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-THUMB-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838598</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-THUMB-SH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:57:03.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952534410012</udiDi>
    <basicUdiDi>69525344SHEET0104C</basicUdiDi>
    <tradeName>06952534410012</tradeName>
    <deviceName>Thermoplastic Sheet</deviceName>
    <manufacturerName>JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008281</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92x61cm</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:48:25.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595566421380</udiDi>
    <basicUdiDi>697442359ICBS3</basicUdiDi>
    <tradeName>Dr. Max Instant Cold Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-IN-200g</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:12:06.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595566425999</udiDi>
    <basicUdiDi>697442359RPAUM</basicUdiDi>
    <tradeName>Dr. Max Hot&amp;Cold Therapy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-CH-350g</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:12:05.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595566426569</udiDi>
    <basicUdiDi>697442359RPAUM</basicUdiDi>
    <tradeName>Dr. Max Hot&amp;Cold Therapy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-CH-170g</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:12:04.968Z</lastUpdated>
  </row>
</eudamedExport>