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    <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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  <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>
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    <udiDi>00855421005352</udiDi>
    <basicUdiDi>B-00855421005352</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6338</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:51.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005345</udiDi>
    <basicUdiDi>B-00855421005345</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6339</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:50.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005338</udiDi>
    <basicUdiDi>B-00855421005338</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6336</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:49.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005321</udiDi>
    <basicUdiDi>B-00855421005321</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6335</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:46.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005314</udiDi>
    <basicUdiDi>B-00855421005314</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6333</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:45.237Z</lastUpdated>
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  <row>
    <udiDi>00855421005307</udiDi>
    <basicUdiDi>B-00855421005307</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Block</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>OP6332</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:44.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005079</udiDi>
    <basicUdiDi>B-00855421005079</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>3S™ 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>OP9312</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:17.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005048</udiDi>
    <basicUdiDi>B-00855421005048</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>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>OP6331</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:14.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005062</udiDi>
    <basicUdiDi>B-00855421005062</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>3S™ 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>OP8312</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:13.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005055</udiDi>
    <basicUdiDi>B-00855421005055</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>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>OP9562</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:12.536Z</lastUpdated>
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  <row>
    <udiDi>00855421005031</udiDi>
    <basicUdiDi>B-00855421005031</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>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>OP6330</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:56.333Z</lastUpdated>
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  <row>
    <udiDi>00855421005024</udiDi>
    <basicUdiDi>B-00855421005024</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Ultra Thin 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>OP7212</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:55.545Z</lastUpdated>
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    <udiDi>00855421005017</udiDi>
    <basicUdiDi>B-00855421005017</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Micro Thin 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>OP8438</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:54.753Z</lastUpdated>
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    <udiDi>00855421005000</udiDi>
    <basicUdiDi>B-00855421005000</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Ultra Thin 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>OP7210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:53.937Z</lastUpdated>
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    <udiDi>08057158962805</udiDi>
    <basicUdiDi>805715896TF05HF</basicUdiDi>
    <tradeName>08057158962805</tradeName>
    <deviceName>Biofibre 4.0 e Medicap High Density 4.0</deviceName>
    <manufacturerName>Medicap S.r.l</manufacturerName>
    <manufacturerSrn>IT-MF-000007995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF24.01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:31:06.436Z</lastUpdated>
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    <udiDi>07540194002235</udiDi>
    <basicUdiDi>7540194GAP-SSNRC</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-SSN55</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:09.101Z</lastUpdated>
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    <udiDi>07540194002129</udiDi>
    <basicUdiDi>7540194GAP-WSHRL</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-WAS100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:03.490Z</lastUpdated>
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