<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>G574U20181410</udiDi>
    <basicUdiDi>B-G574U20181410</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Female - U2018141</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018141</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:45.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U2018140</udiDi>
    <basicUdiDi>B-G574U2018140</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Paediatric Male- U201814</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U201814</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:44.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U2018130</udiDi>
    <basicUdiDi>B-G574U2018130</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Paediatric Male- U201813</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U201813</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:43.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U2018120</udiDi>
    <basicUdiDi>B-G574U2018120</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Paediatric Male- U201812</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U201812</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:41.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181170</udiDi>
    <basicUdiDi>B-G574U20181170</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018117</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018117</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:39.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181160</udiDi>
    <basicUdiDi>B-G574U20181160</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018116</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018116</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:37.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181150</udiDi>
    <basicUdiDi>B-G574U20181150</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018115</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018115</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:36.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181140</udiDi>
    <basicUdiDi>B-G574U20181140</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018114</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018114</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:35.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181130</udiDi>
    <basicUdiDi>B-G574U20181130</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018113</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018113</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:32.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181120</udiDi>
    <basicUdiDi>B-G574U20181120</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018112</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018112</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:31.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181110</udiDi>
    <basicUdiDi>B-G574U20181110</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018111</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018111</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:30.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U20181100</udiDi>
    <basicUdiDi>B-G574U20181100</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018110</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018110</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:28.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>G574U2018110</udiDi>
    <basicUdiDi>B-G574U2018110</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60% Latex Foley Balloon Catheter</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U201811</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:08:26.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>G57420181240</udiDi>
    <basicUdiDi>B-G57420181240</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018124</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018124</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:06:45.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>G57420181210</udiDi>
    <basicUdiDi>B-G57420181210</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018121</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018121</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:06:44.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>G57420181200</udiDi>
    <basicUdiDi>B-G57420181200</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018120</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018120</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:06:40.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>G57420181190</udiDi>
    <basicUdiDi>B-G57420181190</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018119</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2018119</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:06:39.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>G57420181180</udiDi>
    <basicUdiDi>B-G57420181180</basicUdiDi>
    <tradeName>MEDIPLUS</tradeName>
    <deviceName>60 % Latex Foley Balloon Catheter - Standard Male - U2018118</deviceName>
    <manufacturerName>SHREE UMIYA SURGICAL PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000018008</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G57420181180</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:06:38.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>89042427007542</udiDi>
    <basicUdiDi>B-89042427007542</basicUdiDi>
    <tradeName>89042427007542</tradeName>
    <deviceName>100% Silicone Foley Balloon Catheter 2-Way</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 517 BH / SMD 517</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:28.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>89042427007092</udiDi>
    <basicUdiDi>B-89042427007092</basicUdiDi>
    <tradeName>89042427007092</tradeName>
    <deviceName>100% Silicone Foley Balloon Catheter 2-Way</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 517 BH / SMD 517</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:27.352Z</lastUpdated>
  </row>
</eudamedExport>