<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>60913190402252</udiDi>
    <basicUdiDi>60913190GDBTG</basicUdiDi>
    <tradeName>Amara 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>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDB-0221255S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:55.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190402320</udiDi>
    <basicUdiDi>60913190GDBTG</basicUdiDi>
    <tradeName>Amara 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>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDB-0221555S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:53.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190402498</udiDi>
    <basicUdiDi>60913190GDBTG</basicUdiDi>
    <tradeName>Amara 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>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDB-0221855S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:53.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190405390</udiDi>
    <basicUdiDi>60913190UDB-029E</basicUdiDi>
    <tradeName>Tahina 0.018" Ureteroscopy 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-0205040S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:53.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190405536</udiDi>
    <basicUdiDi>60913190UDB-039G</basicUdiDi>
    <tradeName>Tahina 0.038" Nephrostomy 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>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDB-0310120S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:53.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404232</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-0104060S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404300</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-0104100S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404478</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-0105040S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404546</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-0105040LPS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404614</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-0105060S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404782</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-0105100S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404850</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-0106040S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190404928</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-0106040LPS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190405086</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-0106060S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T18:39:30.669Z</lastUpdated>
  </row>
  <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>
  </row>
</eudamedExport>