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    <tradeName>GLIDER Amplatz Sheath</tradeName>
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    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <reference>AM22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.240Z</lastUpdated>
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    <udiDi>00819374021609</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX URETERAL ACCESS SHEATH</tradeName>
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    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
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    <reference>00819374021609</reference>
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    <udiDi>00819374021999</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>ARMADA Dilators &amp; Sets, GLIDER Amplatz Sheath</tradeName>
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    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-24T05:14:13.829Z</lastUpdated>
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    <tradeName>ARMADA Dilators &amp; Sets, GLIDER Amplatz Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-AM20/30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.354Z</lastUpdated>
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    <udiDi>00827002142978</udiDi>
    <basicUdiDi>0827002CINC050-124_A2YS</basicUdiDi>
    <tradeName>Ureteral Dilator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>076000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:50.873Z</lastUpdated>
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    <udiDi>00827002143203</udiDi>
    <basicUdiDi>0827002CINC050-124_B1YT</basicUdiDi>
    <tradeName>Balloon Ureteral Dilator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:50.842Z</lastUpdated>
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  <row>
    <udiDi>00827002144224</udiDi>
    <basicUdiDi>0827002CINC050-124_B1YT</basicUdiDi>
    <tradeName>Balloon Ureteral Dilator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010015</reference>
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    <lastUpdated>2026-06-24T05:03:50.787Z</lastUpdated>
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    <udiDi>00827002145740</udiDi>
    <basicUdiDi>0827002CINC050-124_A2YS</basicUdiDi>
    <tradeName>Ureteral TFE Dilator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>076600</reference>
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    <lastUpdated>2026-06-24T05:03:50.694Z</lastUpdated>
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    <udiDi>00827002146082</udiDi>
    <basicUdiDi>0827002CINC050-124_B1YT</basicUdiDi>
    <tradeName>Balloon Ureteral Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:50.624Z</lastUpdated>
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  <row>
    <udiDi>00827002152625</udiDi>
    <basicUdiDi>0827002CINC050-124_A2YS</basicUdiDi>
    <tradeName>Pediatric Urethral Dilator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:50.484Z</lastUpdated>
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  <row>
    <udiDi>00827002176362</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Ureteral Dilator With AQ® Hydrophilic Coating With Modified Taper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ-076012-TP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:50.053Z</lastUpdated>
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  <row>
    <udiDi>00827002178441</udiDi>
    <basicUdiDi>0827002CINC050-124_BJA</basicUdiDi>
    <tradeName>Urethral Dilation Balloon Catheter With Open Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDBS-070029-OW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:49.920Z</lastUpdated>
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  <row>
    <udiDi>00827002179097</udiDi>
    <basicUdiDi>0827002CINC050-124_A2YS</basicUdiDi>
    <tradeName>Integral Filiform Urethral Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFD-180032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:49.878Z</lastUpdated>
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  <row>
    <udiDi>00827002327894</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator Set with AQ® Hydrophilic Coating</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073701-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:43.636Z</lastUpdated>
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    <udiDi>00827002462496</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator with AQ® Hydrophilic Coating</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073722-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:40.983Z</lastUpdated>
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    <udiDi>00827002462502</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator with AQ® Hydrophilic Coating</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
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    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073724-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:40.956Z</lastUpdated>
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    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator with AQ® Hydrophilic Coating</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
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    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073726-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:40.927Z</lastUpdated>
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    <udiDi>05701780806015</udiDi>
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    <tradeName>EasiCath Dilatation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>283185</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-22T04:34:46.899Z</lastUpdated>
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    <tradeName>EasiCath Dilatation</tradeName>
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    <manufacturerName>Coloplast A/S</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28316</reference>
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    <tradeName>EasiCath Dilatation</tradeName>
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    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28318</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T04:33:57.947Z</lastUpdated>
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