<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M724BSMIIM1</udiDi>
    <basicUdiDi>B-M724BSMIIM1</basicUdiDi>
    <tradeName>M724BSMIIM1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Implantech Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008458</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSMII-M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:35:55.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>M724BSMIIL1</udiDi>
    <basicUdiDi>B-M724BSMIIL1</basicUdiDi>
    <tradeName>M724BSMIIL1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Implantech Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008458</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSMII-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:35:55.064Z</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>
  </row>
  <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>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>08964004821370</udiDi>
    <basicUdiDi>896400482103889</basicUdiDi>
    <tradeName>Dental Gracey Currettes</tradeName>
    <deviceName>Gracey Currettes</deviceName>
    <manufacturerName>Burhan Kamran Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000052581</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P010102</emdnCode>
    <emdnDescription>ZYGOMATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:28:45.710Z</lastUpdated>
  </row>
</eudamedExport>