<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05904647710900</udiDi>
    <basicUdiDi>59046477150026C</basicUdiDi>
    <tradeName>Temblak siatkowy MEK 5002 XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEK-ORTO Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000019251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5002-xs</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:04:55.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904647710917</udiDi>
    <basicUdiDi>59046477150026C</basicUdiDi>
    <tradeName>Temblak siatkowy MEK 5002 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEK-ORTO Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000019251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5002-l</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:04:55.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904647710924</udiDi>
    <basicUdiDi>59046477150026C</basicUdiDi>
    <tradeName>Temblak siatkowy MEK 5002 XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEK-ORTO Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000019251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5002-xl</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:04:55.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904647711013</udiDi>
    <basicUdiDi>590464771400265</basicUdiDi>
    <tradeName>Aparat odwodzący z klinem MEK 4002 XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEK-ORTO Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000019251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4002-cz-xl</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:04:54.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904647711020</udiDi>
    <basicUdiDi>590464771400265</basicUdiDi>
    <tradeName>Aparat odwodzący z klinem MEK 4002 S/M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEK-ORTO Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000019251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4002-cz-sm</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:04:54.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901571424088</udiDi>
    <basicUdiDi>59015714AT040012D</basicUdiDi>
    <tradeName>ORTEZA NA RAMIĘ I BARK TYPU „DESSAULT”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000001583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT04001 (L)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T05:29:16.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901571424095</udiDi>
    <basicUdiDi>59015714AT040012D</basicUdiDi>
    <tradeName>ORTEZA NA RAMIĘ I BARK TYPU „DESSAULT”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000001583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT04001 (M)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T05:29:16.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901571424101</udiDi>
    <basicUdiDi>59015714AT040012D</basicUdiDi>
    <tradeName>ORTEZA NA RAMIĘ I BARK TYPU „DESSAULT”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000001583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT04001 (S)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T05:29:16.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901571424118</udiDi>
    <basicUdiDi>59015714AT040012D</basicUdiDi>
    <tradeName>ORTEZA NA RAMIĘ I BARK TYPU „DESSAULT”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000001583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT04001 (XXL)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T05:29:15.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901571486406</udiDi>
    <basicUdiDi>59015714AT040012D</basicUdiDi>
    <tradeName>ORTEZA NA RAMIĘ I BARK TYPU „DESSAULT”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000001583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT04001 (XS)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T05:29:15.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892933100</udiDi>
    <basicUdiDi>47198728621W8</basicUdiDi>
    <tradeName>Shoulder Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210004(2XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:36.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935159</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Shoulder Abduction Immobilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213101(M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935166</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Shoulder Abduction Immobilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213101(S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935173</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Shoulder Abduction Immobilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213101(XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935234</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Mesh Sling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210001(M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935241</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Mesh Sling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210001(S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935258</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Mesh Sling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210001(XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935265</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>TC Sling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210002(L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935272</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>TC Sling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210002(M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935289</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>TC Sling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y060621</emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210002(S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:34.020Z</lastUpdated>
  </row>
</eudamedExport>