<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00855421005512</udiDi>
    <basicUdiDi>B-00855421005512</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Chin - Medium - Round</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8314</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:57.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005505</udiDi>
    <basicUdiDi>B-00855421005505</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Chin - Small - Round</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8313</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:55.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005499</udiDi>
    <basicUdiDi>B-00855421005499</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Two-Piece Chin - Large</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8322</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:53.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005352</udiDi>
    <basicUdiDi>B-00855421005352</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6338</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:51.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005345</udiDi>
    <basicUdiDi>B-00855421005345</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6339</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:50.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005338</udiDi>
    <basicUdiDi>B-00855421005338</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6336</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:49.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005321</udiDi>
    <basicUdiDi>B-00855421005321</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6335</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:46.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005314</udiDi>
    <basicUdiDi>B-00855421005314</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6333</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:45.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005307</udiDi>
    <basicUdiDi>B-00855421005307</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6332</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:44.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005291</udiDi>
    <basicUdiDi>B-00855421005291</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Ear Base Extended - 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>P020103</emdnCode>
    <emdnDescription>EXTERNAL EAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8331</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:42.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005284</udiDi>
    <basicUdiDi>B-00855421005284</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Ear Base Extended - 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>P020103</emdnCode>
    <emdnDescription>EXTERNAL EAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8330</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:40.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005277</udiDi>
    <basicUdiDi>B-00855421005277</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Helical Rim - 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>P020103</emdnCode>
    <emdnDescription>EXTERNAL EAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8329</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:38.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005260</udiDi>
    <basicUdiDi>B-00855421005260</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Helical Rim - 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>P020103</emdnCode>
    <emdnDescription>EXTERNAL EAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8328</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:38.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005253</udiDi>
    <basicUdiDi>B-00855421005253</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Two-Piece Chin - Medium</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8321</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:36.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005246</udiDi>
    <basicUdiDi>B-00855421005246</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Two-Piece Chin - Small</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP8320</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:34.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005239</udiDi>
    <basicUdiDi>B-00855421005239</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Nasal 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>P020299</emdnCode>
    <emdnDescription>RHINOLOGY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9536</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:32.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005161</udiDi>
    <basicUdiDi>B-00855421005161</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Orbital Sphere-22mm</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>OP6322</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:31.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005154</udiDi>
    <basicUdiDi>B-00855421005154</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Orbital Sphere-20mm</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>OP6317</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:30.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005147</udiDi>
    <basicUdiDi>B-00855421005147</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Orbital Sphere-18mm</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>OP6327</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:27.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005130</udiDi>
    <basicUdiDi>B-00855421005130</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Orbital Sphere-16mm</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>OP6326</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:26.011Z</lastUpdated>
  </row>
</eudamedExport>