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    <basicUdiDi>B-00855421005130</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Orbital Sphere-16mm</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>OP6326</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:26.011Z</lastUpdated>
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    <udiDi>00855421005123</udiDi>
    <basicUdiDi>B-00855421005123</basicUdiDi>
    <tradeName>OmniPore Surgical Implant</tradeName>
    <deviceName>OmiPore Surgical 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>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP6316</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:25.217Z</lastUpdated>
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    <udiDi>00855421005116</udiDi>
    <basicUdiDi>B-00855421005116</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Enophthalmos Wedge - 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>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9544</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:23.610Z</lastUpdated>
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    <udiDi>00855421005109</udiDi>
    <basicUdiDi>B-00855421005109</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Enophthalmos Wedge - 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>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP9543</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:21.208Z</lastUpdated>
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    <udiDi>00855421005093</udiDi>
    <basicUdiDi>B-00855421005093</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Enophthalmos Wedge - Regular - 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>OP9542</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:19.613Z</lastUpdated>
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    <udiDi>00855421005086</udiDi>
    <basicUdiDi>B-00855421005086</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>Enophthalmos Wedge - Regular - 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>OP9541</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:25:18.809Z</lastUpdated>
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    <udiDi>00852578008137</udiDi>
    <basicUdiDi>B-00852578008137</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Large - 1.5mm</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>OP9561</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:28.232Z</lastUpdated>
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    <udiDi>00852578008120</udiDi>
    <basicUdiDi>B-00852578008120</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Large - 1.0mm</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>OP9560</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:25.831Z</lastUpdated>
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    <udiDi>00852578008113</udiDi>
    <basicUdiDi>B-00852578008113</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Small - 1.5mm</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>OP9551</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:24.215Z</lastUpdated>
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  <row>
    <udiDi>00852578008106</udiDi>
    <basicUdiDi>B-00852578008106</basicUdiDi>
    <tradeName>OmniPore</tradeName>
    <deviceName>DUROMAX® Orbital Implant - Small - 1.0mm</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>OP9550</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:23.417Z</lastUpdated>
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    <udiDi>00844369000246</udiDi>
    <basicUdiDi>B-00844369000246</basicUdiDi>
    <tradeName>LR-1400B</tradeName>
    <deviceName>LR-1400B</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LR-1400B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:48:39.723Z</lastUpdated>
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    <udiDi>00844369000222</udiDi>
    <basicUdiDi>B-00844369000222</basicUdiDi>
    <tradeName>LR-1300B</tradeName>
    <deviceName>LR-1300B</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LR-1300B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:48:39.051Z</lastUpdated>
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    <udiDi>06430043960728</udiDi>
    <basicUdiDi>6430043966430043960728XE</basicUdiDi>
    <tradeName>Silmäproteesit Lehto &amp; Sohlberg Oy</tradeName>
    <deviceName>Eye prostheses Lehto &amp; Sohlberg Oy</deviceName>
    <manufacturerName>IsoDent Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023346</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6430043960728</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:54:40.824Z</lastUpdated>
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    <udiDi>04049154000029</udiDi>
    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>ARTIFICIALIRIS FiberFree CUSTOMFLEX®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.564Z</lastUpdated>
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    <udiDi>04049154169313</udiDi>
    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>Artificial Iris with Fiber Select Light Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.330Z</lastUpdated>
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    <udiDi>04049154169320</udiDi>
    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>Artificial Iris FiberFree Select Light Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.307Z</lastUpdated>
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    <udiDi>04049154169337</udiDi>
    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>Artificial Iris with Fiber Select Medium Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.280Z</lastUpdated>
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    <udiDi>04049154169344</udiDi>
    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>Artificial Iris FiberFree Select Medium Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.262Z</lastUpdated>
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    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>Artificial Iris with Fiber Select Dark Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
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    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.243Z</lastUpdated>
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    <basicUdiDi>04049154_AI_M1_H1_O1_X7</basicUdiDi>
    <tradeName>Artificial Iris FiberFree Select Dark Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0399</emdnCode>
    <emdnDescription>OCULAR PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00095122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:51.228Z</lastUpdated>
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