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    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Renal Dilator Set; Amplatz Renal Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-240016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:20.258Z</lastUpdated>
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    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-180016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00827002180048</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</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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    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-300016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:34.441Z</lastUpdated>
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    <udiDi>00827002180161</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-300025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:34.288Z</lastUpdated>
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    <udiDi>00827002460300</udiDi>
    <basicUdiDi>0827002CINC050-123_A3YM</basicUdiDi>
    <tradeName>00827002460300</tradeName>
    <deviceName>Clear Amplatz Sheath With Radiopaque Stripe</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAS-180017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:36.944Z</lastUpdated>
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  <row>
    <udiDi>00827002173224</udiDi>
    <basicUdiDi>0827002CINC050-123_A1YH</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Renal Dilator Set With AQ® Hydrophilic Coating</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ-075000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:35.361Z</lastUpdated>
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    <udiDi>00827002143050</udiDi>
    <basicUdiDi>0827002CINC050-123_A4YP</basicUdiDi>
    <tradeName>00827002143050</tradeName>
    <deviceName>Catheter For Use With Amplatz Renal Dilator Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>075001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:34.544Z</lastUpdated>
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    <udiDi>00827002142923</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Renal Dilator Set; Amplatz Renal Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>075000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:29.743Z</lastUpdated>
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    <udiDi>00827002460317</udiDi>
    <basicUdiDi>0827002CINC050-123_A3YM</basicUdiDi>
    <tradeName>00827002460317</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAS-240017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:39.316Z</lastUpdated>
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    <udiDi>00827002460324</udiDi>
    <basicUdiDi>0827002CINC050-123_A3YM</basicUdiDi>
    <tradeName>00827002460324</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAS-300017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:28.800Z</lastUpdated>
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  <row>
    <udiDi>00827002144859</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>075000-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:22.827Z</lastUpdated>
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    <udiDi>06941513223217</udiDi>
    <basicUdiDi>697005757111HE</basicUdiDi>
    <tradeName>Ureteral Access Sheathes</tradeName>
    <deviceName>Ureteral Access Sheathes</deviceName>
    <manufacturerName>Jiangsu Vedkang Medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008462</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDK-NSA-10350A-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:05:16.284Z</lastUpdated>
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  <row>
    <udiDi>03600040975312</udiDi>
    <basicUdiDi>57089326358428G</basicUdiDi>
    <tradeName>Coloplast</tradeName>
    <deviceName>Ureteral dilator</deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBD010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:49:50.887Z</lastUpdated>
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    <udiDi>03600040975343</udiDi>
    <basicUdiDi>57089326358428G</basicUdiDi>
    <tradeName>Coloplast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBD014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:38:11.165Z</lastUpdated>
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    <udiDi>D-6979246722GD</udiDi>
    <basicUdiDi>B-6979246722GD</basicUdiDi>
    <tradeName>Disposable Ureteral Access Sheaths</tradeName>
    <deviceName>Disposable Ureteral Access Sheaths</deviceName>
    <manufacturerName>Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027760</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:57.490Z</lastUpdated>
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    <udiDi>08964001697800</udiDi>
    <basicUdiDi>89640016976485085U2</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 11 Y 12</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485085</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:54:12.004Z</lastUpdated>
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    <udiDi>00827002173101</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Ureteral Dilator Set Dilators With AQ® Hydrophilic Coating</tradeName>
    <deviceName>Ureteral Dilator [With AQ® Hydrophilic Coating With Modified Taper; Set Dilators With AQ® Hydrophilic Coating; S~Curve® with AQ® Hydrophilic Coating]</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-076000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:30.716Z</lastUpdated>
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    <udiDi>00827002141858</udiDi>
    <basicUdiDi>0827002CINC050-124_A2YS</basicUdiDi>
    <tradeName>Urethral Dilator Set</tradeName>
    <deviceName>Dilator Set [Ureteral; Integral Filiform; Urethral; Tunner Pediatric Urethral]</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>073701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:05.756Z</lastUpdated>
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    <udiDi>00812261012605</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>ARMADA Dilators &amp; Sets</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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NOT6/10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:40.355Z</lastUpdated>
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    <udiDi>08714729005421</udiDi>
    <basicUdiDi>01915060000000000000516N8</basicUdiDi>
    <tradeName>08714729005421</tradeName>
    <deviceName>Renal Dilators  &amp;  Renal Sheath</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>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062601000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:07:41.629Z</lastUpdated>
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