<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00855421005093</udiDi>
    <basicUdiDi>B-00855421005093</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Enophthalmos Wedge - Regular - Right</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9542</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:19.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005086</udiDi>
    <basicUdiDi>B-00855421005086</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Enophthalmos Wedge - Regular - Left</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9541</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:18.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005079</udiDi>
    <basicUdiDi>B-00855421005079</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>3S™ Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9312</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:17.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005048</udiDi>
    <basicUdiDi>B-00855421005048</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP6331</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:14.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005062</udiDi>
    <basicUdiDi>B-00855421005062</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>3S™ Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8312</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:13.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005055</udiDi>
    <basicUdiDi>B-00855421005055</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9562</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:12.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005031</udiDi>
    <basicUdiDi>B-00855421005031</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP6330</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:56.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005024</udiDi>
    <basicUdiDi>B-00855421005024</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Ultra Thin Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7212</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:55.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005017</udiDi>
    <basicUdiDi>B-00855421005017</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Micro Thin Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8438</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:54.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005000</udiDi>
    <basicUdiDi>B-00855421005000</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Ultra Thin Sheet</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:53.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852578008137</udiDi>
    <basicUdiDi>B-00852578008137</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Large - 1.5mm</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9561</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:28.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852578008120</udiDi>
    <basicUdiDi>B-00852578008120</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Large - 1.0mm</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9560</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:25.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852578008113</udiDi>
    <basicUdiDi>B-00852578008113</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Small - 1.5mm</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9551</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:24.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852578008106</udiDi>
    <basicUdiDi>B-00852578008106</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Small - 1.0mm</deviceName>
    <manufacturerName>Matrix Surgical Holdings, LLC dba Matrix Surgical USA</manufacturerName>
    <manufacturerSrn>US-MF-000018643</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9550</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:23.417Z</lastUpdated>
  </row>
</eudamedExport>