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<eudamedExport entity="devices">
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    <udiDi>08714729755814</udiDi>
    <basicUdiDi>01915060000000000000401MN</basicUdiDi>
    <tradeName>Encore™</tradeName>
    <deviceName>Encore™ 26 Inflation Device</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067101140</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:09:11.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729012641</udiDi>
    <basicUdiDi>01915060000000000000531N4</basicUdiDi>
    <tradeName>NephroMax™</tradeName>
    <deviceName>NephroMax High Pressure Balloon Nephrostomy Balloon 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>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062101170</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:00.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729005209</udiDi>
    <basicUdiDi>01915060000000000000602N2</basicUdiDi>
    <tradeName>08714729005209</tradeName>
    <deviceName>UROLOGY INTRODUCERS</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>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067001200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:07:39.986Z</lastUpdated>
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  <row>
    <udiDi>FBCP</udiDi>
    <basicUdiDi>++G401FBCPQ</basicUdiDi>
    <tradeName>Foley Balloon Catheter</tradeName>
    <deviceName>Foley Balloon Catheter (Latex)</deviceName>
    <manufacturerName>Disposafe Health &amp; Lifecare Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000020265</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FB2</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:41:56.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155704485</udiDi>
    <basicUdiDi>890615570PCNSLT</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCN1630LS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:38:19.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155704492</udiDi>
    <basicUdiDi>890615570PCNSLT</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCN1830LS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:38:19.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155704508</udiDi>
    <basicUdiDi>890615570SPCSSNJ</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC1640S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:38:19.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155705178</udiDi>
    <basicUdiDi>890615570PCNSLT</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCN8040S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:38:18.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155705185</udiDi>
    <basicUdiDi>890615570PCNSLT</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCN1440S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:38:18.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000023648PP11265QV</udiDi>
    <basicUdiDi>B-CNMF000023648PP11265QV</basicUdiDi>
    <tradeName>Percutaneous Nephrolithotomy Package</tradeName>
    <deviceName>PCNL Package</deviceName>
    <manufacturerName>Hunan Reborn Medical Science and Technology Development Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023648</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:05:49.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>25060222471353</udiDi>
    <basicUdiDi>B-25060222471353</basicUdiDi>
    <tradeName>OPTILUBE ACTIVE</tradeName>
    <deviceName>OPTILUBE ACTIVE - Sterile Lubricant Gel With Lidocaine, 11mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1161M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:42:03.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104707</udiDi>
    <basicUdiDi>B-24026704104707</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:08.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104691</udiDi>
    <basicUdiDi>B-24026704104691</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:07.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104684</udiDi>
    <basicUdiDi>B-24026704104684</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:06.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104677</udiDi>
    <basicUdiDi>B-24026704104677</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:06.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104660</udiDi>
    <basicUdiDi>B-24026704104660</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:02.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104653</udiDi>
    <basicUdiDi>B-24026704104653</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 3ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:01.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104646</udiDi>
    <basicUdiDi>B-24026704104646</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 3ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340409-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:00.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104639</udiDi>
    <basicUdiDi>B-24026704104639</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340408-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:32:59.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704104622</udiDi>
    <basicUdiDi>B-24026704104622</basicUdiDi>
    <tradeName>Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet</tradeName>
    <deviceName>SUPERGLIDE CATHETER SILICONE 2W 5ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340408-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:32:55.763Z</lastUpdated>
  </row>
</eudamedExport>