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<eudamedExport entity="devices">
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    <udiDi>00860006450397</udiDi>
    <basicUdiDi>B-00860006450397</basicUdiDi>
    <tradeName>Safe-T-Secure</tradeName>
    <deviceName>Safe-T-Secure®</deviceName>
    <manufacturerName>NinoMed</manufacturerName>
    <manufacturerSrn>US-MF-000037124</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011280</emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STSNMED1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:01.215Z</lastUpdated>
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    <udiDi>00857198006013</udiDi>
    <basicUdiDi>B-00857198006013</basicUdiDi>
    <tradeName>Oasis</tradeName>
    <deviceName>Oasis</deviceName>
    <manufacturerName>Segami Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002014</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11029092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.0.1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:19.350Z</lastUpdated>
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    <udiDi>00857198006006</udiDi>
    <basicUdiDi>B-00857198006006</basicUdiDi>
    <tradeName>Oasis</tradeName>
    <deviceName>Oasis</deviceName>
    <manufacturerName>Segami Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002014</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11029092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.9.4.12</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:17.722Z</lastUpdated>
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    <udiDi>00855421005949</udiDi>
    <basicUdiDi>B-00855421005949</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>CHANNEL 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>OP9530</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:45.313Z</lastUpdated>
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  <row>
    <udiDi>00855421005918</udiDi>
    <basicUdiDi>B-00855421005918</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Osteotomy Gap Implant (2 pk)</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>OP7550</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:40.514Z</lastUpdated>
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  <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>
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  <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>
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  <row>
    <udiDi>00855421005857</udiDi>
    <basicUdiDi>B-00855421005857</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Extended Orbital 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>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9539</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:33.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005840</udiDi>
    <basicUdiDi>B-00855421005840</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Inferior Orbital 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>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9430</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:32.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005833</udiDi>
    <basicUdiDi>B-00855421005833</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Inferior Orbital 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>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9429</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:31.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005819</udiDi>
    <basicUdiDi>B-00855421005819</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ TF2 Large - 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>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9862</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:26.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005802</udiDi>
    <basicUdiDi>B-00855421005802</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ TF2 Large - 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>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9861</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:26.096Z</lastUpdated>
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  <row>
    <udiDi>00855421005796</udiDi>
    <basicUdiDi>B-00855421005796</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ TF2 Medium - 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>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9860</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:25.294Z</lastUpdated>
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  <row>
    <udiDi>00855421005789</udiDi>
    <basicUdiDi>B-00855421005789</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ TF2 Medium - 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>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9859</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:24.496Z</lastUpdated>
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  <row>
    <udiDi>00855421005772</udiDi>
    <basicUdiDi>B-00855421005772</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ TF2 Small - 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>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9858</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:20.490Z</lastUpdated>
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    <udiDi>00855421005765</udiDi>
    <basicUdiDi>B-00855421005765</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ TF2 Small - 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>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9857</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:19.697Z</lastUpdated>
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  <row>
    <udiDi>00855421005758</udiDi>
    <basicUdiDi>B-00855421005758</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>BENDBLOCK™ Cranial Grid Implant</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>OP9524</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:18.892Z</lastUpdated>
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  <row>
    <udiDi>00855421005727</udiDi>
    <basicUdiDi>B-00855421005727</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Craniatomy Gap Wedge</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>OP82011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:18.097Z</lastUpdated>
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