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    <basicUdiDi>69502033UBMYRM</basicUdiDi>
    <tradeName>06950203328132</tradeName>
    <deviceName>Ureteral Dilation Balloon Catheters</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UB-MY04040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:46.301Z</lastUpdated>
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    <udiDi>06950203329399</udiDi>
    <basicUdiDi>69502033UBUYSD</basicUdiDi>
    <tradeName>06950203329399</tradeName>
    <deviceName>Ureteral Dilation Balloon Catheters</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UB-UY07060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:45.506Z</lastUpdated>
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    <udiDi>00827002303584</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</tradeName>
    <deviceName>Ultraxx™ Nephrostomy Balloon [With TFE Sheath: 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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-10-15-CS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:36.166Z</lastUpdated>
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    <udiDi>00827002303645</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-10-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:02.478Z</lastUpdated>
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    <udiDi>00827002460331</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-6-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:01.016Z</lastUpdated>
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  <row>
    <udiDi>00827002460232</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-6-15-CS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:59.160Z</lastUpdated>
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    <udiDi>00827002460348</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-8-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:58.561Z</lastUpdated>
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    <udiDi>00827002460355</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-8-15-CS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:54.694Z</lastUpdated>
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  <row>
    <udiDi>00827002178427</udiDi>
    <basicUdiDi>0827002CINC050-124_BJA</basicUdiDi>
    <tradeName>Urethral Dilation Balloon Catheter With Coudé Tip</tradeName>
    <deviceName>Urethral Dilation Balloon Catheter</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-090029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:31.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002142619</udiDi>
    <basicUdiDi>0827002CINC050-124_B1YT</basicUdiDi>
    <tradeName>Balloon Ureteral Dilator</tradeName>
    <deviceName>Balloon Ureteral 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:09.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261012582</udiDi>
    <basicUdiDi>081226101BDR009KX</basicUdiDi>
    <tradeName>UreTrack Ureteral Balloon Dilator</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UBD5/4</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:36.358Z</lastUpdated>
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    <udiDi>08714729341109</udiDi>
    <basicUdiDi>01915060000000000000532N6</basicUdiDi>
    <tradeName>UroMax Ultra™</tradeName>
    <deviceName>UroMax Ultra Balloon Dilation Catheter</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062251000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:27.706Z</lastUpdated>
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  <row>
    <udiDi>08699412312263</udiDi>
    <basicUdiDi>B-08699412312263</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>URETERAL BALLOON DILATOR 6 mm 4 cm 75cm and INFLATION DEVICE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533026</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:10.777Z</lastUpdated>
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    <udiDi>08699412312256</udiDi>
    <basicUdiDi>B-08699412312256</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>URETERAL BALLOON DILATOR 5 mm 4 cm  75 cm and INFLATION DEVICE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:09.981Z</lastUpdated>
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    <udiDi>08699412312249</udiDi>
    <basicUdiDi>B-08699412312249</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>URETERAL BALLOON DILATOR 4 mm 4 cm 75cm and INFLATION DEVICE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533027</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:09.174Z</lastUpdated>
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    <udiDi>08699412312225</udiDi>
    <basicUdiDi>B-08699412312225</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>TRANSURETEROSCOPIC URETERAL BALLOON DILATOR 4 mm 4 cm 75 cm and INFLATION DEVICE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533022</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:04.375Z</lastUpdated>
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    <udiDi>08699412312164</udiDi>
    <basicUdiDi>B-08699412312164</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>URETERAL BALLOON DILATOR 8 mm 4 cm  75cm</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533016</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:27:58.773Z</lastUpdated>
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    <udiDi>08699412312140</udiDi>
    <basicUdiDi>B-08699412312140</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>TRANSURETEROSCOPIC URETERAL BALLOON DILATOR 4 mm 4 cm 75 cm</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:27:57.968Z</lastUpdated>
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    <udiDi>08699412312126</udiDi>
    <basicUdiDi>B-08699412312126</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>URETERAL BALLOON DILATOR 7 mm 5 cm  75cm</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:27:56.377Z</lastUpdated>
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    <udiDi>08699412312119</udiDi>
    <basicUdiDi>B-08699412312119</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>URETERAL BALLOON DILATOR 7 mm 4 cm  75cm</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:27:52.370Z</lastUpdated>
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