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<eudamedExport entity="devices">
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    <udiDi>00726893114982</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>ONE® Mixed Pleasures™</tradeName>
    <deviceName>Non-sterile, Non-medicated Natural Rubber Latex Male Condoms</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110132</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:52:22.672Z</lastUpdated>
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  <row>
    <udiDi>08906155701743</udiDi>
    <basicUdiDi>890615570SDYV</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Screw Dilator &amp; Set</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>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDS8/2430</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:34.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155700876</udiDi>
    <basicUdiDi>890615570SPCSLN4</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Suprapubic Catheterisation Set - Latex</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>MDR 2017/745</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC8040L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:34.463Z</lastUpdated>
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  <row>
    <udiDi>08906155700807</udiDi>
    <basicUdiDi>890615570SPCSSNJ</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Suprapubic Catheterisation Set - Silicone</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>MDR 2017/745</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC6030S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:30.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155700586</udiDi>
    <basicUdiDi>890615570MCSQH</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Malecot Nephrostomy Drainage Catheter &amp; Set</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>MDR 2017/745</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC8030S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:29.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155700302</udiDi>
    <basicUdiDi>890615570PCNWNSPS</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>percutaneous nephrostomy drainage catheter with needle</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>MDR 2017/745</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNN6022</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:28.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155700203</udiDi>
    <basicUdiDi>890615570PCNSLT</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Percutaneous Nephrostomy Drainage Catheter &amp; Set</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>MDR 2017/745</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCN6030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:28.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155700180</udiDi>
    <basicUdiDi>890615570SBYR</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Stone Retrieval Basket (Stainless Steel/Nitinol)</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>MDR 2017/745</legislation>
    <emdnCode>U090101</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL BASKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBN301100T</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:24.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906155700005</udiDi>
    <basicUdiDi>890615570DJSPR</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Double J Catheter(Stent)</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>MDR 2017/745</legislation>
    <emdnCode>U020399</emdnCode>
    <emdnDescription>URETERAL STENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DJ6026OE</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:23.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516069119</udiDi>
    <basicUdiDi>890551622T3</basicUdiDi>
    <tradeName>08905516069119</tradeName>
    <deviceName>PTFE Guidewire</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0699</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCGW0118070</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:23.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516043195</udiDi>
    <basicUdiDi>890551620SX</basicUdiDi>
    <tradeName>08905516043195</tradeName>
    <deviceName>Stone Basket</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090101</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL BASKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUSB01224070S</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:07.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516042785</udiDi>
    <basicUdiDi>890551619TE</basicUdiDi>
    <tradeName>08905516042785</tradeName>
    <deviceName>Endopyelotomy Stent Kit</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUES0240816</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:06.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516041986</udiDi>
    <basicUdiDi>890551618TC</basicUdiDi>
    <tradeName>08905516041986</tradeName>
    <deviceName>Endopyelotomy Stent</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUES0140816</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:02.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516041900</udiDi>
    <basicUdiDi>890551617TA</basicUdiDi>
    <tradeName>08905516041900</tradeName>
    <deviceName>Suprapubic Catheter Kit</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCSC2208025</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:01.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516041801</udiDi>
    <basicUdiDi>890551616T8</basicUdiDi>
    <tradeName>08905516041801</tradeName>
    <deviceName>Suprapubic Catheter</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCSC0208025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:00.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516031512</udiDi>
    <basicUdiDi>890551615T6</basicUdiDi>
    <tradeName>08905516031512</tradeName>
    <deviceName>PCN Catheter Kit / 
Nephrostomy Catheter Kit</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCPC2506030</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:59.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516015499</udiDi>
    <basicUdiDi>890551614T4</basicUdiDi>
    <tradeName>08905516015499</tradeName>
    <deviceName>PCN Catheter / 
Nephrostomy Catheter</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUUF121040</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:55.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516012450</udiDi>
    <basicUdiDi>890551613T2</basicUdiDi>
    <tradeName>08905516012450</tradeName>
    <deviceName>Ureteral Catheter</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020199</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITHOUT BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUUC0103070</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:55.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516011002</udiDi>
    <basicUdiDi>890551612SY</basicUdiDi>
    <tradeName>08905516011002</tradeName>
    <deviceName>Re-entry Malecot Catheter</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BURM0108430</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:54.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516007647</udiDi>
    <basicUdiDi>890551611SW</basicUdiDi>
    <tradeName>08905516007647</tradeName>
    <deviceName>Malecot Catheter Kit</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BCMC0506030</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:53.913Z</lastUpdated>
  </row>
</eudamedExport>