<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08905080012153</udiDi>
    <basicUdiDi>8905080BPGW6F</basicUdiDi>
    <tradeName>Amplatz Extra Stiff Guidewire J Tip</tradeName>
    <deviceName>Guidewire</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>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAES032080JT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:28.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080010203</udiDi>
    <basicUdiDi>8905080BSBGN</basicUdiDi>
    <tradeName>N Quadra [Nitinol Stone Basket With Tip]</tradeName>
    <deviceName>Stone Baskets</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>U090101</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL BASKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BESBN003070T1</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:27.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080009405</udiDi>
    <basicUdiDi>8905080BSDC5D</basicUdiDi>
    <tradeName>Suprapubic Catheter</tradeName>
    <deviceName>Suprapubic Drainage Catheter</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>U010103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, MALECOT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSCP00802500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:25.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080009139</udiDi>
    <basicUdiDi>8905080BNDCSHVH</basicUdiDi>
    <tradeName>Nephrostomy Drainage Set Direct Puncture</tradeName>
    <deviceName>Nephrostomy Drainage Catheter Set</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>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEPCP00703005</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:23.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080008972</udiDi>
    <basicUdiDi>8905080BNDCHWF</basicUdiDi>
    <tradeName>PCN Catheter</tradeName>
    <deviceName>Nephrostomy Drainage Catheter</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>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEPCP00603001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:22.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080008477</udiDi>
    <basicUdiDi>8905080BUCGW</basicUdiDi>
    <tradeName>Ureteral Catheter Open End</tradeName>
    <deviceName>Mono J Catheter &amp; Set</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>U020199</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITHOUT BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUCP00307001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:21.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080008316</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName>Ureteral Access Sheath</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>BUAB09502800</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:19.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080001614</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Both Ends Open with String</tradeName>
    <deviceName>Ureteral Stent</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00301003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:17.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000686</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName>Percutaneous Dilators</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>BFDN0060200S</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:15.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080002970</udiDi>
    <basicUdiDi>8905080BUSH7E</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Both Ends Open with String &amp; Hydrophilic Coating</tradeName>
    <deviceName>Ureteral Stent</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00301007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:14.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000556</udiDi>
    <basicUdiDi>8905080BPGWHZ8</basicUdiDi>
    <tradeName>Prime Wire Straight Tip</tradeName>
    <deviceName>Guidewires</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>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPTN032150HS</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:13.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000419</udiDi>
    <basicUdiDi>8905080BUGW78</basicUdiDi>
    <tradeName>PTFE Guidewire</tradeName>
    <deviceName>Guidewire</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEPTS032150ST</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:11.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005056</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00401028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005063</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00401228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005070</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00401428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005087</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00401628</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005094</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB04701228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005100</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB04701428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005117</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB04701628</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080005124</udiDi>
    <basicUdiDi>8905080BUSHW</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set One End Closed with String</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB04701828</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:34:24.687Z</lastUpdated>
  </row>
</eudamedExport>