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    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:57:30.801Z</lastUpdated>
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    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</tradeName>
    <deviceName>Guidewire: Hydrophilic  (Non-Vascular)</deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:56:01.944Z</lastUpdated>
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    <udiDi>04250098847216</udiDi>
    <basicUdiDi>04250098810051EK</basicUdiDi>
    <tradeName>UROMED UROavenue Guide Wire</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:20.802Z</lastUpdated>
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    <udiDi>04250098846554</udiDi>
    <basicUdiDi>04250098810049EY</basicUdiDi>
    <tradeName>UROMED multiflex Guide Wire</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2716</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:15.996Z</lastUpdated>
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    <udiDi>04250098837156</udiDi>
    <basicUdiDi>04250098810052EM</basicUdiDi>
    <tradeName>UROMED Guide Wire</tradeName>
    <deviceName>GI02</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:07.998Z</lastUpdated>
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    <udiDi>04250098805957</udiDi>
    <basicUdiDi>04250098810050EH</basicUdiDi>
    <tradeName>UROMED Guide Wire »standard«</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:37:47.990Z</lastUpdated>
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    <udiDi>04250098805681</udiDi>
    <basicUdiDi>04250098810053EP</basicUdiDi>
    <tradeName>UROMED Guide Wire »Lunderquist ASP«</tradeName>
    <deviceName>GI03</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:37:47.203Z</lastUpdated>
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    <udiDi>04250098805568</udiDi>
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    <tradeName>UROMED Guide Wire »Lunderquist«</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:37:46.409Z</lastUpdated>
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    <udiDi>04250098847186</udiDi>
    <basicUdiDi>04250098810051EK</basicUdiDi>
    <tradeName>UROMED UROavenue Guide Wire</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:19.288Z</lastUpdated>
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    <udiDi>04250098845892</udiDi>
    <basicUdiDi>04250098810049EY</basicUdiDi>
    <tradeName>UROMED multiflex Guide Wire</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2714</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:16.906Z</lastUpdated>
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    <udiDi>04250098837033</udiDi>
    <basicUdiDi>04250098810052EM</basicUdiDi>
    <tradeName>UROMED Guide Wire</tradeName>
    <deviceName>GI02</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4271</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:06.483Z</lastUpdated>
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    <udiDi>04250098805773</udiDi>
    <basicUdiDi>04250098810050EH</basicUdiDi>
    <tradeName>UROMED Guide Wire »standard«</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2722</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:39.278Z</lastUpdated>
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    <udiDi>04250098805650</udiDi>
    <basicUdiDi>04250098810053EP</basicUdiDi>
    <tradeName>UROMED Guide Wire »Lunderquist ASP«</tradeName>
    <deviceName>GI03</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2711</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:38.472Z</lastUpdated>
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    <udiDi>04250098805537</udiDi>
    <basicUdiDi>04250098810048EW</basicUdiDi>
    <tradeName>UROMED Guide Wire »Lunderquist«</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:37.677Z</lastUpdated>
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    <udiDi>06937440443705</udiDi>
    <basicUdiDi>69368888LGA001VM</basicUdiDi>
    <tradeName>Disposable Urological Guidewire</tradeName>
    <deviceName>Disposable Urological Guidewire</deviceName>
    <manufacturerName>Zhejiang YiGao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032913</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YGE-LG35150A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:07:57.092Z</lastUpdated>
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    <udiDi>06937440458655</udiDi>
    <basicUdiDi>69368888LGA001VM</basicUdiDi>
    <tradeName>Disposable Urological Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang YiGao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032913</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YGE-LG32150A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:55:05.752Z</lastUpdated>
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    <udiDi>00816349015243</udiDi>
    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWAS-038150-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:51:17.604Z</lastUpdated>
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    <udiDi>00816349015205</udiDi>
    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWA-038150-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:51:15.551Z</lastUpdated>
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    <udiDi>00816349015175</udiDi>
    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW-038150-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:51:15.362Z</lastUpdated>
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    <udiDi>00816349015229</udiDi>
    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWAS-035150-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:51:13.626Z</lastUpdated>
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