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    <tradeName>SION blue ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHW14R017P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:08:25.694Z</lastUpdated>
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    <tradeName>SION blue ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>AHW14R317P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:08:25.634Z</lastUpdated>
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    <udiDi>00763000758646</udiDi>
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    <tradeName>Confida™</tradeName>
    <deviceName>Confida™  Brecker Guidewire</deviceName>
    <manufacturerName>Medtronic CoreValve LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019985</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GWBC30</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T01:29:56.563Z</lastUpdated>
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    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>Grand Slam</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG141302J</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T00:38:05.065Z</lastUpdated>
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    <udiDi>00816349014987</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>PV Tracker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABFBF-006V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:34.879Z</lastUpdated>
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    <udiDi>00816349014970</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>PV Tracker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABFBF-005V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:30.415Z</lastUpdated>
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    <udiDi>00816349014871</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>PV Tracker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABFBF-004V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:30.167Z</lastUpdated>
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    <udiDi>00816349013539</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404569-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:29.888Z</lastUpdated>
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    <udiDi>00816349013546</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404570-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:29.262Z</lastUpdated>
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    <udiDi>00816349013553</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404578-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:29.091Z</lastUpdated>
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    <udiDi>00816349013560</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404571-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:28.820Z</lastUpdated>
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    <udiDi>00816349013577</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404577-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:28.129Z</lastUpdated>
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    <udiDi>00816349013584</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404610-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:27.905Z</lastUpdated>
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    <udiDi>00816349013591</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404617-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:19.100Z</lastUpdated>
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    <udiDi>00816349013607</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>GuideRight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404840-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:18.801Z</lastUpdated>
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    <udiDi>00816349013614</udiDi>
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    <tradeName>GuideRight</tradeName>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404843-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:18.594Z</lastUpdated>
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    <tradeName>GuideRight</tradeName>
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    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404844-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:18.464Z</lastUpdated>
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    <tradeName>GuideRight</tradeName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404878-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:18.292Z</lastUpdated>
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    <tradeName>GuideRight</tradeName>
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    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404568-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:17.566Z</lastUpdated>
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    <tradeName>GuideRight</tradeName>
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    <manufacturerName>Lake Region Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404555-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:39:17.398Z</lastUpdated>
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