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    <basicUdiDi>B-00855421005680</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Mandible Onlay - 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>P010103</emdnCode>
    <emdnDescription>MANDIBULAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7545</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:10.898Z</lastUpdated>
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  <row>
    <udiDi>00855421005673</udiDi>
    <basicUdiDi>B-00855421005673</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Mandible Onlay - 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>P010103</emdnCode>
    <emdnDescription>MANDIBULAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7544</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:06.891Z</lastUpdated>
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    <udiDi>00855421005666</udiDi>
    <basicUdiDi>B-00855421005666</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Mandible Onlay - 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>P010103</emdnCode>
    <emdnDescription>MANDIBULAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7543</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:06.092Z</lastUpdated>
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    <udiDi>00855421005659</udiDi>
    <basicUdiDi>B-00855421005659</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Mandible Onlay - 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>P010103</emdnCode>
    <emdnDescription>MANDIBULAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7542</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:05.291Z</lastUpdated>
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    <udiDi>00855421005642</udiDi>
    <basicUdiDi>B-00855421005642</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Mandible Onlay - 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>P010103</emdnCode>
    <emdnDescription>MANDIBULAR PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP7541</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:04.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005635</udiDi>
    <basicUdiDi>B-00855421005635</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Pterional Implant - 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>OP9865</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:28.507Z</lastUpdated>
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  <row>
    <udiDi>00855421005628</udiDi>
    <basicUdiDi>B-00855421005628</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Pterional Implant - 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>OP9864</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:26.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005611</udiDi>
    <basicUdiDi>B-00855421005611</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Malar - 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>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9518</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:25.304Z</lastUpdated>
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  <row>
    <udiDi>00855421005604</udiDi>
    <basicUdiDi>B-00855421005604</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Malar - 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>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9517</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:24.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005598</udiDi>
    <basicUdiDi>B-00855421005598</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Malar - 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>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9516</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:23.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005581</udiDi>
    <basicUdiDi>B-00855421005581</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Malar - 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>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9515</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:19.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005567</udiDi>
    <basicUdiDi>B-00855421005567</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Malar - 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>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9513</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:18.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005550</udiDi>
    <basicUdiDi>B-00855421005550</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Chin - Large - Square</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>OP8318</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:18.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005574</udiDi>
    <basicUdiDi>B-00855421005574</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Malar - 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>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9514</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:17.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005543</udiDi>
    <basicUdiDi>B-00855421005543</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Chin - Medium - Square</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>OP8317</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:26:13.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005536</udiDi>
    <basicUdiDi>B-00855421005536</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Chin - Small - Square</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>OP8316</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:59.642Z</lastUpdated>
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  <row>
    <udiDi>00855421005529</udiDi>
    <basicUdiDi>B-00855421005529</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Design Y™ Chin - Large - 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>OP8315</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:58.039Z</lastUpdated>
  </row>
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    <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>
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    <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>
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