<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08905080046837</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01003500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080046844</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01004500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080046851</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01005500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080049692</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01103500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080049708</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01104500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080049715</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01105500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080049722</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB01102800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:32:23.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000693</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0080200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000709</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0100200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000716</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0120200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000723</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0140200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000730</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0160200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000747</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0180200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000754</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0200200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000761</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0060220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000778</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0080220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000785</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0100220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000792</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0120220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000808</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0140220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000815</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0160220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.395Z</lastUpdated>
  </row>
</eudamedExport>