<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M724ACM1</udiDi>
    <basicUdiDi>B-M724ACM1</basicUdiDi>
    <tradeName>M724ACM1</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:34:29.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>M724ACL1</udiDi>
    <basicUdiDi>B-M724ACL1</basicUdiDi>
    <tradeName>M724ACL1</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>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:34:27.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708765</udiDi>
    <basicUdiDi>B-03700469708765</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325/03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:21.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708758</udiDi>
    <basicUdiDi>B-03700469708758</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325/02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:19.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708741</udiDi>
    <basicUdiDi>B-03700469708741</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325/01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:18.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708734</udiDi>
    <basicUdiDi>B-03700469708734</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:17.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708727</udiDi>
    <basicUdiDi>B-03700469708727</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:14.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708710</udiDi>
    <basicUdiDi>B-03700469708710</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:13.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700469708703</udiDi>
    <basicUdiDi>B-03700469708703</basicUdiDi>
    <tradeName>EUROSILICONE S.A.S.</tradeName>
    <deviceName>Chin Implant</deviceName>
    <manufacturerName>EUROSILICONE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000008947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010101</emdnCode>
    <emdnDescription>CHIN PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:50:12.454Z</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>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>
  </row>
  <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>
  <row>
    <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>
  <row>
    <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>
  <row>
    <udiDi>00855421005253</udiDi>
    <basicUdiDi>B-00855421005253</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Two-Piece Chin - Medium</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>OP8321</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:36.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855421005246</udiDi>
    <basicUdiDi>B-00855421005246</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Two-Piece Chin - Small</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>OP8320</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:34.021Z</lastUpdated>
  </row>
</eudamedExport>