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    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Trachea/Bronchium Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTS-14-030-050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:31:42.932Z</lastUpdated>
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    <udiDi>08806367019141</udiDi>
    <basicUdiDi>B-08806367019141</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Trachea/Bronchium Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTS-12-030-050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:31:37.544Z</lastUpdated>
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    <udiDi>08806367004413</udiDi>
    <basicUdiDi>B-08806367004413</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Trachea/Bronchium Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTS-10-060-090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:20.022Z</lastUpdated>
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    <udiDi>08806367004406</udiDi>
    <basicUdiDi>B-08806367004406</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Trachea/Bronchium Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTS-10-040-090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:19.201Z</lastUpdated>
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  <row>
    <udiDi>08806367004390</udiDi>
    <basicUdiDi>B-08806367004390</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Trachea/Bronchium Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTS-10-030-090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:18.385Z</lastUpdated>
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  <row>
    <udiDi>08806367004352</udiDi>
    <basicUdiDi>B-08806367004352</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Trachea/Bronchium Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTS-10-030-050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:17.595Z</lastUpdated>
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    <udiDi>14063108105483</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105483</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSB121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:40.075Z</lastUpdated>
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    <udiDi>14063108105490</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105490</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSB122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:40.061Z</lastUpdated>
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    <udiDi>14063108105506</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105506</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02 RSB123</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:40.045Z</lastUpdated>
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    <udiDi>14063108105513</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105513</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSB124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:40.029Z</lastUpdated>
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    <udiDi>14063108105520</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105520</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSB125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:40.010Z</lastUpdated>
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    <udiDi>14063108105537</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105537</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSB126</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.988Z</lastUpdated>
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    <udiDi>14063108105544</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105544</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSG140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.977Z</lastUpdated>
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    <udiDi>14063108105551</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105551</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSG141</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.965Z</lastUpdated>
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    <udiDi>14063108105568</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105568</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSG142</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.950Z</lastUpdated>
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    <udiDi>14063108105575</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105575</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSG143</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.934Z</lastUpdated>
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    <udiDi>14063108105582</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105582</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSG144</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.922Z</lastUpdated>
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    <basicUdiDi>4063108TONBN</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSR130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.907Z</lastUpdated>
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    <tradeName>14063108105605</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSR131</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.894Z</lastUpdated>
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    <udiDi>14063108105612</udiDi>
    <basicUdiDi>4063108TONBN</basicUdiDi>
    <tradeName>14063108105612</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATECH SA</manufacturerName>
    <manufacturerSrn>FR-MF-000001658</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0480</emdnCode>
    <emdnDescription>RESPIRATORY PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02BRSR132</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:39.874Z</lastUpdated>
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