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    <tradeName>Hi-Torque Connect</tradeName>
    <deviceName>Hi-Torque Connect</deviceName>
    <manufacturerName>Lake Region Medical (Galway)</manufacturerName>
    <manufacturerSrn>IE-MF-000035376</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020299</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012587</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:21:34.916Z</lastUpdated>
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    <basicUdiDi>081634901PERIPHERALGW3C</basicUdiDi>
    <tradeName>Victory</tradeName>
    <deviceName>Victory 14, 195cm, 12g 1-Pack</deviceName>
    <manufacturerName>Lake Region Medical (Galway)</manufacturerName>
    <manufacturerSrn>IE-MF-000035376</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H74939472195120</reference>
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    <udiDi>10801902198188</udiDi>
    <basicUdiDi>08019020000000000000234KK</basicUdiDi>
    <tradeName>Spring-Wire Guide .018" (0.46 mm) diameter x 17-3/4" (45 cm) wire / Proximal End: Solid Wire .018" diameter / Distal End: Coil .018" diameter x 9 cm</tradeName>
    <deviceName>Peripheral Vascular Spring-Wire Guide Product</deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-MF-000024256</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PW-18045</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:12.109Z</lastUpdated>
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    <udiDi>08714729799207</udiDi>
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    <tradeName>V-14™ Control Wire™</tradeName>
    <deviceName>V-14 ControlWire Guirewire</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020201</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H74939216718210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:09:21.376Z</lastUpdated>
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    <udiDi>08714729035954</udiDi>
    <basicUdiDi>01915060000000000000493NM</basicUdiDi>
    <tradeName>Platinum Plus™</tradeName>
    <deviceName>Platinum PlusTM Guidewire and Platinum PlusTM Guidewire with GlidexTM Hydrophilic Coating</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020299</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M001466010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:01.213Z</lastUpdated>
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    <udiDi>08714729762553</udiDi>
    <basicUdiDi>01915060000000000000282N6</basicUdiDi>
    <tradeName>FATHOM™</tradeName>
    <deviceName>Fathom Steerable Guidewire</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M001509100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:57:59.881Z</lastUpdated>
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    <udiDi>08714729201878</udiDi>
    <basicUdiDi>01915060000000000000281N4</basicUdiDi>
    <tradeName>Transend™</tradeName>
    <deviceName>Neuro TRANSEND GUIDEWIRE  WITH ICE HYDROPHILIC COATING</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020201</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M003468020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:57:03.583Z</lastUpdated>
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    <udiDi>08714729070184</udiDi>
    <basicUdiDi>01915060000000000000284NA</basicUdiDi>
    <tradeName>V-18™ Control Wire™</tradeName>
    <deviceName>V-18™ ControlWire™</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020201</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M001468500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:56:49.958Z</lastUpdated>
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    <udiDi>D-QB090450AJ9</udiDi>
    <basicUdiDi>B-QB090450AJ9</basicUdiDi>
    <tradeName>Heety</tradeName>
    <deviceName>Catheter Sheath Sets</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QB090450A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:16.803Z</lastUpdated>
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    <udiDi>00816349013096</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</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>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-153V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.137Z</lastUpdated>
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    <udiDi>00816349013102</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</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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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-154V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.110Z</lastUpdated>
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    <udiDi>00816349013119</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</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>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-155V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.072Z</lastUpdated>
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    <udiDi>00816349013126</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</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>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-156V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.035Z</lastUpdated>
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    <tradeName>Starter</tradeName>
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    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-157V</reference>
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    <lastUpdated>2026-07-15T02:08:05.004Z</lastUpdated>
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    <tradeName>Starter</tradeName>
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    <manufacturerName>Lake Region Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-158V</reference>
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    <lastUpdated>2026-07-15T02:08:04.977Z</lastUpdated>
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    <tradeName>Starter</tradeName>
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    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-159V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.946Z</lastUpdated>
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    <tradeName>Starter</tradeName>
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    <manufacturerName>Lake Region Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-160V</reference>
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    <lastUpdated>2026-07-15T02:08:04.916Z</lastUpdated>
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    <tradeName>Starter</tradeName>
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    <manufacturerName>Lake Region Medical</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-161V</reference>
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    <lastUpdated>2026-07-15T02:08:04.889Z</lastUpdated>
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    <manufacturerName>Lake Region Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-162V</reference>
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    <lastUpdated>2026-07-15T02:08:04.859Z</lastUpdated>
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    <manufacturerName>Lake Region Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-163V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.825Z</lastUpdated>
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