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    <deviceName>Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surf</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-554B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:56:50.730Z</lastUpdated>
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    <tradeName>00846159025552</tradeName>
    <deviceName>Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surf</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surf</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <reference>1001-552B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>00846159025538</tradeName>
    <deviceName>Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surf</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-551B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:56:45.104Z</lastUpdated>
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    <udiDi>00846159025521</udiDi>
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    <tradeName>00846159025521</tradeName>
    <deviceName>Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surf</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-550B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:56:44.314Z</lastUpdated>
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    <udiDi>00846159023985</udiDi>
    <basicUdiDi>B-00846159023985</basicUdiDi>
    <tradeName>00846159023985</tradeName>
    <deviceName>Scanlan® VASCU-STATT® approximator single-use bulldog clamp</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:53:28.039Z</lastUpdated>
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    <udiDi>00846159023626</udiDi>
    <basicUdiDi>B-00846159023626</basicUdiDi>
    <tradeName>00846159023626</tradeName>
    <deviceName>SCANLAN® Tunneler Storage/Sterilization Tray</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019010</emdnCode>
    <emdnDescription>INTRAVASCULAR RECANALISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-26</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:52:47.204Z</lastUpdated>
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    <tradeName>00846159023602</tradeName>
    <deviceName>SCANLAN® Vascular Tunneler</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019010</emdnCode>
    <emdnDescription>INTRAVASCULAR RECANALISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-24</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:52:45.596Z</lastUpdated>
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    <tradeName>00846159023596</tradeName>
    <deviceName>SCANLAN® A/V Access Tunneler</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019010</emdnCode>
    <emdnDescription>INTRAVASCULAR RECANALISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:52:44.804Z</lastUpdated>
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    <udiDi>00846159023589</udiDi>
    <basicUdiDi>B-00846159023589</basicUdiDi>
    <tradeName>00846159023589</tradeName>
    <deviceName>SCANLAN® A/V Access Tunneler</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019010</emdnCode>
    <emdnDescription>INTRAVASCULAR RECANALISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-14</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:52:40.803Z</lastUpdated>
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    <udiDi>00846159023572</udiDi>
    <basicUdiDi>B-00846159023572</basicUdiDi>
    <tradeName>00846159023572</tradeName>
    <deviceName>SCANLAN® Vascular Tunneler</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019010</emdnCode>
    <emdnDescription>INTRAVASCULAR RECANALISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-13</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:52:40.002Z</lastUpdated>
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    <udiDi>00846159023541</udiDi>
    <basicUdiDi>B-00846159023541</basicUdiDi>
    <tradeName>00846159023541</tradeName>
    <deviceName>SCANLAN® Sartor Tunneler</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019010</emdnCode>
    <emdnDescription>INTRAVASCULAR RECANALISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:52:39.192Z</lastUpdated>
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    <basicUdiDi>B-00845225012878</basicUdiDi>
    <tradeName>IntraSight</tradeName>
    <deviceName>IntraSight</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>797403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:13.584Z</lastUpdated>
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    <udiDi>00845225012663</udiDi>
    <basicUdiDi>B-00845225012663</basicUdiDi>
    <tradeName>CORE M2 Vascular System</tradeName>
    <deviceName>Core M2</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>400-0100.17</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:06.377Z</lastUpdated>
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    <udiDi>00845225012434</udiDi>
    <basicUdiDi>B-00845225012434</basicUdiDi>
    <tradeName>SyncVision Medical Image Processing System</tradeName>
    <deviceName>SyncVision</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400-0100.10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:05.589Z</lastUpdated>
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    <tradeName>CORE Mobile System Medical Equipment</tradeName>
    <deviceName>Core Mobile</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>400-0100.07</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:04.777Z</lastUpdated>
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    <udiDi>00845225010300</udiDi>
    <basicUdiDi>B-00845225010300</basicUdiDi>
    <tradeName>CORE Series Precision Guided Therapy System</tradeName>
    <deviceName>Core</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>400-0100.02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:00.775Z</lastUpdated>
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    <tradeName>s5i</tradeName>
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    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>807400001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:59.968Z</lastUpdated>
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    <basicUdiDi>B-00845225003197</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD24130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:59.175Z</lastUpdated>
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    <basicUdiDi>B-00845225003180</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD24130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:58.374Z</lastUpdated>
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