<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00855421005710</udiDi>
    <basicUdiDi>B-00855421005710</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>JR™  Ear Base - 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>OP8333</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:14.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005703</udiDi>
    <basicUdiDi>B-00855421005703</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>JR™  Ear Base - 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>OP8332</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:13.395Z</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>
</eudamedExport>