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<eudamedExport entity="devices">
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    <udiDi>08904428700424</udiDi>
    <basicUdiDi>B-08904428700424</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Fluoroplastic Offset Total Prosthesis</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010101</emdnCode>
    <emdnDescription>OSSICULAR PROSTHESES (PORP AND TORP)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2142</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:12:00.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904428700417</udiDi>
    <basicUdiDi>B-08904428700417</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Fluoroplastic Offset Partial Prosthesis</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010101</emdnCode>
    <emdnDescription>OSSICULAR PROSTHESES (PORP AND TORP)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2141</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:11:59.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904428700363</udiDi>
    <basicUdiDi>B-08904428700363</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Fluoroplastic Partial Prosthesis</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010101</emdnCode>
    <emdnDescription>OSSICULAR PROSTHESES (PORP AND TORP)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2133</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:11:57.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904428700370</udiDi>
    <basicUdiDi>B-08904428700370</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Fluoroplastic Total Prosthesis</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010101</emdnCode>
    <emdnDescription>OSSICULAR PROSTHESES (PORP AND TORP)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2134</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:11:55.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904428700349</udiDi>
    <basicUdiDi>B-08904428700349</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Fluoroplastic Stapes Piston (Shaft Dia.: 0.4 mm)</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010102</emdnCode>
    <emdnDescription>STAPEDIOPLASTIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2128</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:11:52.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000048</udiDi>
    <basicUdiDi>03856410497_INTSPLINTSLP</basicUdiDi>
    <tradeName>00385640000048</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-27005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000055</udiDi>
    <basicUdiDi>03856410497_INTSPLINTSLP</basicUdiDi>
    <tradeName>00385640000055</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-27010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000062</udiDi>
    <basicUdiDi>03856410497_INTSPLINTSLP</basicUdiDi>
    <tradeName>00385640000062</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-27015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:07:28.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250381804346</udiDi>
    <basicUdiDi>B-04250381804346</basicUdiDi>
    <tradeName>04250381804346</tradeName>
    <deviceName>Dummy length sizer for middle ear implants</deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:40:23.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005895</udiDi>
    <basicUdiDi>B-00855421005895</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Large Paranasal - 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>P020299</emdnCode>
    <emdnDescription>RHINOLOGY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9526</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:39.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005888</udiDi>
    <basicUdiDi>B-00855421005888</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Large Paranasal - 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>P020299</emdnCode>
    <emdnDescription>RHINOLOGY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9525</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:38.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005871</udiDi>
    <basicUdiDi>B-00855421005871</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Petite Paranasal - 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>P020299</emdnCode>
    <emdnDescription>RHINOLOGY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9520</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:38.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005864</udiDi>
    <basicUdiDi>B-00855421005864</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Petite Paranasal - 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>P020299</emdnCode>
    <emdnDescription>RHINOLOGY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9519</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:34.106Z</lastUpdated>
  </row>
  <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>
  <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>
</eudamedExport>