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    <tradeName>Tahina 0.038" Ureteral Balloon Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENVASTE LTD</manufacturerName>
    <manufacturerSrn>MU-MF-000030801</manufacturerSrn>
    <authorisedRepresentativeName>ENVASTE LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000028866</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDB-0106040LPS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.690Z</lastUpdated>
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    <basicUdiDi>60913190UDB-019C</basicUdiDi>
    <tradeName>Tahina 0.038" Ureteral Balloon Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENVASTE LTD</manufacturerName>
    <manufacturerSrn>MU-MF-000030801</manufacturerSrn>
    <authorisedRepresentativeName>ENVASTE LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000028866</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDB-0106060S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.669Z</lastUpdated>
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  <row>
    <udiDi>60913190405154</udiDi>
    <basicUdiDi>60913190UDB-019C</basicUdiDi>
    <tradeName>Tahina 0.038" Ureteral Balloon Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENVASTE LTD</manufacturerName>
    <manufacturerSrn>MU-MF-000030801</manufacturerSrn>
    <authorisedRepresentativeName>ENVASTE LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000028866</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDB-0106100S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.615Z</lastUpdated>
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  <row>
    <udiDi>00812261019697</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>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T14:07:11.086Z</lastUpdated>
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  <row>
    <udiDi>00812261019680</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>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T14:07:09.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261019673</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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T14:07:08.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261014258</udiDi>
    <basicUdiDi>081226101BDR009KX</basicUdiDi>
    <tradeName>NephroTrack Nephrostomy Track 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>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T14:06:04.007Z</lastUpdated>
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  <row>
    <udiDi>00812261012704</udiDi>
    <basicUdiDi>081226101BDR009KX</basicUdiDi>
    <tradeName>NephroTrack Nephrostomy Track 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>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T14:00:24.504Z</lastUpdated>
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    <udiDi>00812261012698</udiDi>
    <basicUdiDi>081226101BDR009KX</basicUdiDi>
    <tradeName>NephroTrack Nephrostomy Track 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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T14:00:23.409Z</lastUpdated>
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  <row>
    <udiDi>00819374021265</udiDi>
    <basicUdiDi>081226101BDR009KX</basicUdiDi>
    <tradeName>NephroTrack Nephrostomy Track 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>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T08:01:21.888Z</lastUpdated>
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