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    <tradeName>R-100 Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBKBG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:39.871Z</lastUpdated>
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    <udiDi>00845225012915</udiDi>
    <basicUdiDi>B-00845225012915</basicUdiDi>
    <tradeName>IntraSight Mobile System</tradeName>
    <deviceName>IntraSight Mobile</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>797415</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:39.072Z</lastUpdated>
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    <udiDi>00845225012878</udiDi>
    <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>2026-07-05T05:20:38.392Z</lastUpdated>
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    <udiDi>00845225012694</udiDi>
    <basicUdiDi>B-00845225012694</basicUdiDi>
    <tradeName>Digital IVUS Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5902VC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:23.017Z</lastUpdated>
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    <udiDi>00845225012687</udiDi>
    <basicUdiDi>B-00845225012687</basicUdiDi>
    <tradeName>SpinVision Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>891BG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:21.445Z</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>2026-07-05T05:20:20.610Z</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>
    <emdnCode>C010499</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400-0100.10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:19.039Z</lastUpdated>
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    <udiDi>00845225012274</udiDi>
    <basicUdiDi>B-00845225012274</basicUdiDi>
    <tradeName>CORE Mobile System Medical Equipment</tradeName>
    <deviceName>Core Mobile</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>400-0100.07</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:16.615Z</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>
    <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>400-0100.02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:15.013Z</lastUpdated>
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    <udiDi>00845225010218</udiDi>
    <basicUdiDi>B-00845225010218</basicUdiDi>
    <tradeName>s5i</tradeName>
    <deviceName>s5i</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>807400001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:14.208Z</lastUpdated>
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    <udiDi>00845225003197</udiDi>
    <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>2026-07-05T05:20:12.602Z</lastUpdated>
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    <udiDi>00845225003180</udiDi>
    <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>2026-07-05T05:20:10.200Z</lastUpdated>
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    <udiDi>00845225003173</udiDi>
    <basicUdiDi>B-00845225003173</basicUdiDi>
    <tradeName>Phoenix 1.5mm x 149cm 4F 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>P15149K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:08.609Z</lastUpdated>
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    <udiDi>00845225003166</udiDi>
    <basicUdiDi>B-00845225003166</basicUdiDi>
    <tradeName>Phoenix 1.5mm x 149cm 4F 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>P15149</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:07.802Z</lastUpdated>
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    <udiDi>00845225003067</udiDi>
    <basicUdiDi>B-00845225003067</basicUdiDi>
    <tradeName>Reconnaissance PV .018 OTW Digital IVUS Catheter</tradeName>
    <deviceName>Reconnaissance</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>C0104020102</emdnCode>
    <emdnDescription>INTRAVASCULAR ULTRASOUND CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018OTW</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:06.202Z</lastUpdated>
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    <udiDi>00845225003050</udiDi>
    <basicUdiDi>B-00845225003050</basicUdiDi>
    <tradeName>OmniWire Pressure Guide Wire</tradeName>
    <deviceName>OmniWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89185J</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:03.795Z</lastUpdated>
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    <udiDi>00845225003043</udiDi>
    <basicUdiDi>B-00845225003043</basicUdiDi>
    <tradeName>OmniWire Pressure Guide Wire</tradeName>
    <deviceName>OmniWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89185</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:02.197Z</lastUpdated>
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    <udiDi>00845225002992</udiDi>
    <basicUdiDi>B-00845225002992</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F 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>PD22130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:01.395Z</lastUpdated>
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    <udiDi>00845225002985</udiDi>
    <basicUdiDi>B-00845225002985</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F 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>PD22130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:59.795Z</lastUpdated>
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    <udiDi>00845225002978</udiDi>
    <basicUdiDi>B-00845225002978</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F 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>P24130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:57.392Z</lastUpdated>
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