<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05907419649125</udiDi>
    <basicUdiDi>5907419649PWTRORTGX</basicUdiDi>
    <tradeName>Poliwater ORT udowy (S)</tradeName>
    <deviceName>Poliwater ORT</deviceName>
    <manufacturerName>LIGATIO PROSTA SPÓŁKA AKCYJNA</manufacturerName>
    <manufacturerSrn>PL-MF-000045533</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Poliwater ORT udowy (S)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:21:53.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906667448023</udiDi>
    <basicUdiDi>5906667448ZPWTRSE</basicUdiDi>
    <tradeName>Zestaw do unieruchamiania kończyn Poliwater</tradeName>
    <deviceName>Zestaw do unieruchamiania kończyn Poliwater</deviceName>
    <manufacturerName>POLIWATER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-PR-000042164</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Przedramię (S)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:18:40.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906306266209</udiDi>
    <basicUdiDi>59063062662PWTR2Z</basicUdiDi>
    <tradeName>poliwater</tradeName>
    <deviceName>poliwater syntetyczny opatrunek unieruchamiający</deviceName>
    <manufacturerName>POLIWATER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000042165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Przedramię (S)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:13:05.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904125000028</udiDi>
    <basicUdiDi>59041250BREASTPROSTHES73</basicUdiDi>
    <tradeName>Proteza Piersi Maxima</tradeName>
    <deviceName>Proteza Piersi Maxima</deviceName>
    <manufacturerName>PRZEDSIĘBIORSTWO OBROTU I FABRYKACJI ARTYKUŁÓW MEDYCZNYCH "POFAM- POZNAŃ" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000050850</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7004-LEWA-T01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:24:39.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060873850251</udiDi>
    <basicUdiDi>506087385SMPIGMENTSRH</basicUdiDi>
    <tradeName>QWWH - QuickWeigh HCR White 200g</tradeName>
    <deviceName>Spectromatch Silicone Pigments</deviceName>
    <manufacturerName>Spectromatch Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009147</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QWWH-200</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:13.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060873850008</udiDi>
    <basicUdiDi>506087385SMSILICONESPF</basicUdiDi>
    <tradeName>CSG35 - Cosmetic Silicone Gum 35 shore 10kg</tradeName>
    <deviceName>Silicones</deviceName>
    <manufacturerName>Spectromatch Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009147</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSG 35-10</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:11.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060483012117</udiDi>
    <basicUdiDi>506048301TF3D9</basicUdiDi>
    <tradeName>High Strength Silicone Rubber - 1kg</tradeName>
    <deviceName>Prosthetic Silicone Materials</deviceName>
    <manufacturerName>Technovent Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000006738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z004(1kg)</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:47:48.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242684173</udiDi>
    <basicUdiDi>50602426830JL</basicUdiDi>
    <tradeName>05060242684173</tradeName>
    <deviceName>Toe Protectors</deviceName>
    <manufacturerName>Burton McCall Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000051789</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP3010</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:35:39.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>05054522002306</udiDi>
    <basicUdiDi>5054522000146QM</basicUdiDi>
    <tradeName>Custom Sensory Vest</tradeName>
    <deviceName>DMO Custom Sensory Vest</deviceName>
    <manufacturerName>DM Orthotics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008260</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM 45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:07:54.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>05054522002252</udiDi>
    <basicUdiDi>5054522000139QQ</basicUdiDi>
    <tradeName>Custom Sensory Suit</tradeName>
    <deviceName>DMO Custom Sensory Suit</deviceName>
    <manufacturerName>DM Orthotics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008260</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM 39</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:07:53.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>05054522001828</udiDi>
    <basicUdiDi>5054522SENSORY26</basicUdiDi>
    <tradeName>Sensory Vest Adult size XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DM Orthotics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008260</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SENVA1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:07:47.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04750283076174</udiDi>
    <basicUdiDi>4750283RECLNXT</basicUdiDi>
    <tradeName>Reklinators atlēgas kaula fiksācijai</tradeName>
    <deviceName>Orthopedic products</deviceName>
    <manufacturerName>TONUS ELAST SIA</manufacturerName>
    <manufacturerSrn>LV-MF-000006828</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELAST 1705</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:57:39.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719894928159</udiDi>
    <basicUdiDi>471989492LINERRK</basicUdiDi>
    <tradeName>04719894928159</tradeName>
    <deviceName>Liner</deviceName>
    <manufacturerName>e-life International Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000043583</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-PSLBCFL-M3U001A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:52:09.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719894927671</udiDi>
    <basicUdiDi>471989492CARBONFOOTNK</basicUdiDi>
    <tradeName>04719894927671</tradeName>
    <deviceName>Carbon Foot</deviceName>
    <manufacturerName>e-life International Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000043583</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-PFT0722-NN0400A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:52:08.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710374233961</udiDi>
    <basicUdiDi>471230298HMQR</basicUdiDi>
    <tradeName>Cranial Protection Helmet</tradeName>
    <deviceName>Cranial orthosis</deviceName>
    <manufacturerName>e-life International Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000009901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MHMP801 (Universal/UNI/PK)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:22:51.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262583680000</udiDi>
    <basicUdiDi>42700050053HPOCDR</basicUdiDi>
    <tradeName>O.C. NOW HAIRPIECE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>O.C. Hairsystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000050963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O.C./IFU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:46:07.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650648</udiDi>
    <basicUdiDi>426242965P030208RV</basicUdiDi>
    <tradeName>Lumo Module Connector</tradeName>
    <deviceName>Lumo Module Connector</deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650648</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:36:08.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650563</udiDi>
    <basicUdiDi>426242965P030207RT</basicUdiDi>
    <tradeName>Lumo Spacer, STD-A</tradeName>
    <deviceName>Lumo Spacer</deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262429650563</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:36:07.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650426</udiDi>
    <basicUdiDi>426242965P030205RP</basicUdiDi>
    <tradeName>Lumo Clamp Module</tradeName>
    <deviceName>Lumo Clamp Module</deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03071000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:36:06.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262429650419</udiDi>
    <basicUdiDi>426242965P030203RK</basicUdiDi>
    <tradeName>Lumo Roll Module</tradeName>
    <deviceName>Lumo Roll Module</deviceName>
    <manufacturerName>macu4 GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y0699</emdnCode>
    <emdnDescription>EXTERNAL PROSTHESES AND ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03051000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:36:05.938Z</lastUpdated>
  </row>
</eudamedExport>