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<eudamedExport entity="devices">
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    <basicUdiDi>B-05060491614648</basicUdiDi>
    <tradeName>Paragon Infant PP Oxygenator</tradeName>
    <deviceName>Paragon Infant PP Oxygenator</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP140PP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:40.186Z</lastUpdated>
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    <udiDi>05060491610350</udiDi>
    <basicUdiDi>B-05060491610350</basicUdiDi>
    <tradeName>05060491610350</tradeName>
    <deviceName>Paragon Adult Maxi Integrated Oxygenator with MicroNet Filter</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300MN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:32.151Z</lastUpdated>
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  <row>
    <udiDi>05060491610244</udiDi>
    <basicUdiDi>B-05060491610244</basicUdiDi>
    <tradeName>05060491610244</tradeName>
    <deviceName>Paragon Paediatric Integrated Oxygenator with MicroNet Filter</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI160MN</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:30.559Z</lastUpdated>
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    <udiDi>05060491610220</udiDi>
    <basicUdiDi>B-05060491610220</basicUdiDi>
    <tradeName>05060491610220</tradeName>
    <deviceName>Paragon Paediatric PMP Oxygenator</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP165PMP</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:28.152Z</lastUpdated>
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  <row>
    <udiDi>05060491610213</udiDi>
    <basicUdiDi>B-05060491610213</basicUdiDi>
    <tradeName>05060491610213</tradeName>
    <deviceName>Paragon Infant PMP Oxygenator</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP145PMP</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:26.558Z</lastUpdated>
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  <row>
    <udiDi>05060491610206</udiDi>
    <basicUdiDi>B-05060491610206</basicUdiDi>
    <tradeName>05060491610206</tradeName>
    <deviceName>Paragon Neonatal PMP Oxygenator</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP43PMP</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:25.753Z</lastUpdated>
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  <row>
    <udiDi>05060491610190</udiDi>
    <basicUdiDi>B-05060491610190</basicUdiDi>
    <tradeName>05060491610190</tradeName>
    <deviceName>Paragon Adult Maxi PMP Oxygenator</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP305PMP</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:24.150Z</lastUpdated>
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  <row>
    <udiDi>05055715632492</udiDi>
    <basicUdiDi>B-05055715632492</basicUdiDi>
    <tradeName>05055715632492</tradeName>
    <deviceName>Aorfix™ AAA Endovascular Stent Graft with Intelliflex™ Low Profile Delivery System</deviceName>
    <manufacturerName>Lombard Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000014515</manufacturerSrn>
    <authorisedRepresentativeName>Medical Device Management Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002496</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019009</emdnCode>
    <emdnDescription>AORTIC OCCLUSION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-24-81-63-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:28:04.936Z</lastUpdated>
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  <row>
    <udiDi>04996404613204</udiDi>
    <basicUdiDi>B-04996404613204</basicUdiDi>
    <tradeName>PuraStat Nozzle System Type L</tradeName>
    <deviceName>PuraStat Nozzle System Type L</deviceName>
    <manufacturerName>TOP Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000011618</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900180</emdnCode>
    <emdnDescription>HAEMOSTASIS SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>634163</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:46:34.464Z</lastUpdated>
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  <row>
    <udiDi>04987488107604</udiDi>
    <basicUdiDi>B-04987488107604</basicUdiDi>
    <tradeName>Najuta Thoracic Stent Graft System</tradeName>
    <deviceName>Najuta Thoracic Stent Graft System</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR8L-S42CL3-3U95</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:50.424Z</lastUpdated>
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  <row>
    <udiDi>04987488107550</udiDi>
    <basicUdiDi>B-04987488107550</basicUdiDi>
    <tradeName>Najuta Thoracic Stent Graft System</tradeName>
    <deviceName>Najuta Thoracic Stent Graft System</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR8L-S42CL3-3U95</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:48.025Z</lastUpdated>
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  <row>
    <udiDi>04772085010170</udiDi>
    <basicUdiDi>B-04772085010170</basicUdiDi>
    <tradeName>N-ELUTAX “3”</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-ELUTAX “3” 20600</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:27.353Z</lastUpdated>
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  <row>
    <udiDi>04772085010149</udiDi>
    <basicUdiDi>B-04772085010149</basicUdiDi>
    <tradeName>N-ELUTAX “3”</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-ELUTAX “3” 20500</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:23.347Z</lastUpdated>
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  <row>
    <udiDi>04772085005404</udiDi>
    <basicUdiDi>B-04772085005404</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25400</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:22.553Z</lastUpdated>
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    <udiDi>04772085005398</udiDi>
    <basicUdiDi>B-04772085005398</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25350</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:21.746Z</lastUpdated>
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    <udiDi>04772085005381</udiDi>
    <basicUdiDi>B-04772085005381</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25325</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:20.948Z</lastUpdated>
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    <udiDi>04772085005374</udiDi>
    <basicUdiDi>B-04772085005374</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25300</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:16.945Z</lastUpdated>
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    <udiDi>04772085005367</udiDi>
    <basicUdiDi>B-04772085005367</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25275</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:16.203Z</lastUpdated>
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    <udiDi>04772085005350</udiDi>
    <basicUdiDi>B-04772085005350</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25250</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:15.449Z</lastUpdated>
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    <udiDi>04772085005343</udiDi>
    <basicUdiDi>B-04772085005343</basicUdiDi>
    <tradeName>ELUTAX “3”-RX</tradeName>
    <deviceName>Paclitaxel coated balloon catheter ELUTAX "3"</deviceName>
    <manufacturerName>AR Baltic Medical UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000004402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELUTAX “3”-RX 25225</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:13.738Z</lastUpdated>
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