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    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>GR-AR-000023077</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL27/30</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:20.816Z</lastUpdated>
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    <udiDi>07630033300193</udiDi>
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    <tradeName>Europa Ultra™</tradeName>
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    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL27/25</reference>
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    <lastUpdated>2026-06-30T09:51:19.619Z</lastUpdated>
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    <udiDi>07630033300186</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-30T09:51:18.418Z</lastUpdated>
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    <udiDi>07630033300179</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL27/15</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:12.423Z</lastUpdated>
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    <udiDi>07630033300162</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL27/10</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:11.242Z</lastUpdated>
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    <udiDi>07630033300155</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL25/30</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:10.021Z</lastUpdated>
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    <udiDi>07630033300148</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL25/25</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:08.821Z</lastUpdated>
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    <udiDi>07630033300131</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL25/20</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:02.825Z</lastUpdated>
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  <row>
    <udiDi>07630033300124</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>GR-AR-000023077</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL25/15</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:01.604Z</lastUpdated>
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  <row>
    <udiDi>07630033300117</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>GR-AR-000023077</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL25/10</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:51:00.413Z</lastUpdated>
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  <row>
    <udiDi>07630033300100</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>GR-AR-000023077</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL22/30</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:59.202Z</lastUpdated>
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  <row>
    <udiDi>07630033300094</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>GR-AR-000023077</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL22/25</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:53.212Z</lastUpdated>
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  <row>
    <udiDi>07630033300087</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL22/20</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:52.003Z</lastUpdated>
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  <row>
    <udiDi>07630033300070</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL22/15</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:50.802Z</lastUpdated>
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    <udiDi>07630033300063</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL22/10</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:49.661Z</lastUpdated>
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    <udiDi>07630033300056</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL20/30</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:43.599Z</lastUpdated>
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    <udiDi>07630033300049</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL20/25</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:42.388Z</lastUpdated>
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    <udiDi>07630033300032</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL20/20</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:41.208Z</lastUpdated>
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    <udiDi>07630033300025</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL20/15</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:39.993Z</lastUpdated>
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    <udiDi>07630033300018</udiDi>
    <basicUdiDi>076300333EF_CBLCATHGG</basicUdiDi>
    <tradeName>Europa Ultra™</tradeName>
    <deviceName>Europa Ultra Coronary Balloon Catheter</deviceName>
    <manufacturerName>Rontis Corporation SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031411</manufacturerSrn>
    <authorisedRepresentativeName>RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>GR-AR-000023077</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL20/10</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:33.993Z</lastUpdated>
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