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    <tradeName>PTS-X</tradeName>
    <deviceName>PTS-X</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTSX102</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:13.134Z</lastUpdated>
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    <udiDi>10887714009652</udiDi>
    <basicUdiDi>B-10887714009652</basicUdiDi>
    <tradeName>PTS-X</tradeName>
    <deviceName>PTS-X</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTSX101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:08.319Z</lastUpdated>
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    <udiDi>10887714009645</udiDi>
    <basicUdiDi>B-10887714009645</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS405</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:07.533Z</lastUpdated>
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    <udiDi>10887714009638</udiDi>
    <basicUdiDi>B-10887714009638</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS404</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:06.723Z</lastUpdated>
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    <udiDi>10887714009621</udiDi>
    <basicUdiDi>B-10887714009621</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:06.445Z</lastUpdated>
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    <udiDi>10887714009614</udiDi>
    <basicUdiDi>B-10887714009614</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS305</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:01.127Z</lastUpdated>
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    <udiDi>10887714009607</udiDi>
    <basicUdiDi>B-10887714009607</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS304</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:55:00.317Z</lastUpdated>
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    <udiDi>10887714009591</udiDi>
    <basicUdiDi>B-10887714009591</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS303</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:59.514Z</lastUpdated>
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    <udiDi>10887714009584</udiDi>
    <basicUdiDi>B-10887714009584</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS253</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:58.733Z</lastUpdated>
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    <udiDi>10887714009577</udiDi>
    <basicUdiDi>B-10887714009577</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>PTS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTS203</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:53.927Z</lastUpdated>
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    <udiDi>00813132024840</udiDi>
    <basicUdiDi>B-00813132024840</basicUdiDi>
    <tradeName>Bridge Occlusion Balloon</tradeName>
    <deviceName>Bridge Occlusion Balloon</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>590-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:52.785Z</lastUpdated>
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    <udiDi>08720214005333</udiDi>
    <basicUdiDi>B-08720214005333</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-24</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:25.377Z</lastUpdated>
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    <udiDi>08720214005326</udiDi>
    <basicUdiDi>B-08720214005326</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-22</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:24.198Z</lastUpdated>
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    <udiDi>08720214005319</udiDi>
    <basicUdiDi>B-08720214005319</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-20</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:22.988Z</lastUpdated>
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    <udiDi>08720214005302</udiDi>
    <basicUdiDi>B-08720214005302</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-18</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:16.968Z</lastUpdated>
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    <udiDi>08720214005296</udiDi>
    <basicUdiDi>B-08720214005296</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-16</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:15.775Z</lastUpdated>
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    <udiDi>08720214005289</udiDi>
    <basicUdiDi>B-08720214005289</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-14</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:14.569Z</lastUpdated>
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    <udiDi>08720214005272</udiDi>
    <basicUdiDi>B-08720214005272</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:13.365Z</lastUpdated>
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    <udiDi>08720214005265</udiDi>
    <basicUdiDi>B-08720214005265</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:07.359Z</lastUpdated>
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    <udiDi>08720214005258</udiDi>
    <basicUdiDi>B-08720214005258</basicUdiDi>
    <tradeName>Cera</tradeName>
    <deviceName>Cera™ Vascular Plug System</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-PLUG-08</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:05:06.191Z</lastUpdated>
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