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    <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>2026-08-01T15:42:53.563Z</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>2026-08-01T15:42:52.763Z</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>2026-08-01T15:42:51.968Z</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>2026-08-01T15:42:51.180Z</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>2026-08-01T15:42:47.182Z</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>2026-08-01T15:42:46.374Z</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>2026-08-01T15:42:45.568Z</lastUpdated>
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  <row>
    <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>2026-08-01T15:42:44.768Z</lastUpdated>
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  <row>
    <udiDi>00845225002961</udiDi>
    <basicUdiDi>B-00845225002961</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F 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>P24130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:39.964Z</lastUpdated>
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  <row>
    <udiDi>00845225002909</udiDi>
    <basicUdiDi>B-00845225002909</basicUdiDi>
    <tradeName>Verrata Plus Pressure Guide Wire</tradeName>
    <deviceName>Verrata Plus</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10300JP</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:39.161Z</lastUpdated>
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  <row>
    <udiDi>00845225002893</udiDi>
    <basicUdiDi>B-00845225002893</basicUdiDi>
    <tradeName>Verrata Plus Pressure Guide Wire</tradeName>
    <deviceName>Verrata Plus</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10300P</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:38.372Z</lastUpdated>
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    <udiDi>00845225002886</udiDi>
    <basicUdiDi>B-00845225002886</basicUdiDi>
    <tradeName>Verrata Plus Pressure Guide Wire</tradeName>
    <deviceName>Verrata Plus</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>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10185JP</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:42:37.574Z</lastUpdated>
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    <udiDi>00845225002879</udiDi>
    <basicUdiDi>B-00845225002879</basicUdiDi>
    <tradeName>Verrata Plus Pressure Guide Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10185P</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:38.489Z</lastUpdated>
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  <row>
    <udiDi>00845225002848</udiDi>
    <basicUdiDi>B-00845225002848</basicUdiDi>
    <tradeName>Visions PV .014P RX Digital IVUS Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0104020102</emdnCode>
    <emdnDescription>INTRAVASCULAR ULTRASOUND CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:37.693Z</lastUpdated>
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  <row>
    <udiDi>00845225002732</udiDi>
    <basicUdiDi>B-00845225002732</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 149cm 6F 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>P22149K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:36.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225002725</udiDi>
    <basicUdiDi>B-00845225002725</basicUdiDi>
    <tradeName>Phoenix 1.8mm x 149cm 5F 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>P18149K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:36.157Z</lastUpdated>
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    <udiDi>00845225002718</udiDi>
    <basicUdiDi>B-00845225002718</basicUdiDi>
    <tradeName>Phoenix 2.4mm 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>PD24127K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:20.784Z</lastUpdated>
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    <udiDi>00845225002701</udiDi>
    <basicUdiDi>B-00845225002701</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F 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>P22130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:19.985Z</lastUpdated>
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    <udiDi>00845225002695</udiDi>
    <basicUdiDi>B-00845225002695</basicUdiDi>
    <tradeName>Phoenix 1.8mm x 130cm 5F 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>P18130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:19.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225002657</udiDi>
    <basicUdiDi>B-00845225002657</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 149cm 6F 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>P22149</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:40:18.382Z</lastUpdated>
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