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    <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>
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    <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>
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  <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>
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    <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>
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  <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>
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    <udiDi>08434048516179</udiDi>
    <basicUdiDi>843404825SURGORL3P</basicUdiDi>
    <tradeName>SET MIRINGO REUTER</tradeName>
    <deviceName>Agrupaciones Miringotomía</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P02010201</emdnCode>
    <emdnDescription>TRANSTYMPANIC DRAINAGE PROSTHESES (VENTILATION TUBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET2137</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:37:13.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048326990</udiDi>
    <basicUdiDi>843404825ORLDILATADORCJ</basicUdiDi>
    <tradeName>Set desechable Balón ETD 6X20</tradeName>
    <deviceName>Agrupaciones Dilatación ORL</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P02010299</emdnCode>
    <emdnDescription>EXTERNAL-MIDDLE EAR IMPLANTS- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG0620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:36:56.967Z</lastUpdated>
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  <row>
    <udiDi>04250381804452</udiDi>
    <basicUdiDi>B-04250381804452</basicUdiDi>
    <tradeName>04250381804452</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:15.150Z</lastUpdated>
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  <row>
    <udiDi>04250381804445</udiDi>
    <basicUdiDi>B-04250381804445</basicUdiDi>
    <tradeName>04250381804445</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:14.242Z</lastUpdated>
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  <row>
    <udiDi>04250381804438</udiDi>
    <basicUdiDi>B-04250381804438</basicUdiDi>
    <tradeName>04250381804438</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:13.343Z</lastUpdated>
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  <row>
    <udiDi>04250381804421</udiDi>
    <basicUdiDi>B-04250381804421</basicUdiDi>
    <tradeName>04250381804421</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:12.444Z</lastUpdated>
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  <row>
    <udiDi>04250381804414</udiDi>
    <basicUdiDi>B-04250381804414</basicUdiDi>
    <tradeName>04250381804414</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:11.546Z</lastUpdated>
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    <udiDi>04250381804407</udiDi>
    <basicUdiDi>B-04250381804407</basicUdiDi>
    <tradeName>04250381804407</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:10.649Z</lastUpdated>
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    <udiDi>04250381804391</udiDi>
    <basicUdiDi>B-04250381804391</basicUdiDi>
    <tradeName>04250381804391</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:09.748Z</lastUpdated>
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    <udiDi>04250381804384</udiDi>
    <basicUdiDi>B-04250381804384</basicUdiDi>
    <tradeName>04250381804384</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:08.843Z</lastUpdated>
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  <row>
    <udiDi>04250381804377</udiDi>
    <basicUdiDi>B-04250381804377</basicUdiDi>
    <tradeName>04250381804377</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:07.948Z</lastUpdated>
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    <udiDi>04250381804360</udiDi>
    <basicUdiDi>B-04250381804360</basicUdiDi>
    <tradeName>04250381804360</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SPIGGLE &amp; THEIS Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006647</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020180</emdnCode>
    <emdnDescription>OTOLOGIC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000-D15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T12:44:07.040Z</lastUpdated>
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