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<eudamedExport entity="devices">
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    <udiDi>08032248484047</udiDi>
    <basicUdiDi>803224848401A5</basicUdiDi>
    <tradeName>Vesico-Urethral coaxial Catheter for urodynamic examination b8Fr (Ø2.64mm, 400mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Med SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000027962</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050199</emdnCode>
    <emdnDescription>CYSTOMANOMETRY AND URETHROMANOMETRY CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MBP5811M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:45:04.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248479029</udiDi>
    <basicUdiDi>803224847901AP</basicUdiDi>
    <tradeName>Double-lumen catheter for pressure flow study</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Med SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000027962</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050202</emdnCode>
    <emdnDescription>BLADDER PRESSURE-FLOW STUDY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-CDL050L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:45:03.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248476523</udiDi>
    <basicUdiDi>803224847651AP</basicUdiDi>
    <tradeName>Double-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr, (Ø3,96, L=200mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Med SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000027962</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050402</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ADRE122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:45:02.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248474024</udiDi>
    <basicUdiDi>8032248474019W</basicUdiDi>
    <tradeName>Single-lumen rectal catheter for urodynamic examinatiom with silicone balloon,  12Fr (Ø3,96mm, L=400mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Med SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000027962</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050402</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MBP4521</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:59.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248471023</udiDi>
    <basicUdiDi>8032248471019F</basicUdiDi>
    <tradeName>Foley Manometer LV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Delta Med SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000027962</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050401</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITHOUT BALLOON</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HM002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:57.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090062393014</udiDi>
    <basicUdiDi>7090062390069Y</basicUdiDi>
    <tradeName>PRESSURO</tradeName>
    <deviceName>PRESSURO</deviceName>
    <manufacturerName>InVivo Bionics AS</manufacturerName>
    <manufacturerSrn>NO-MF-000038625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050401</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITHOUT BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVB-10000</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:17:05.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974617178305</udiDi>
    <basicUdiDi>697461717CY1SN</basicUdiDi>
    <tradeName>06974617178305</tradeName>
    <deviceName>Intra-Abdominal Pressure Monitoring Device</deviceName>
    <manufacturerName>Hubei MeterOmega Technology LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000016732</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U050401</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITHOUT BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>322800</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:03:08.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133510</udiDi>
    <basicUdiDi>69449327FU08C01MX</basicUdiDi>
    <tradeName>Tube Accessories for Urodynamic Catheter</tradeName>
    <deviceName>Tube Accessories for Urodynamic Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FU08C010410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:00.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133466</udiDi>
    <basicUdiDi>69449327FU08A01MM</basicUdiDi>
    <tradeName>Wellead Urodynamic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A010710</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133473</udiDi>
    <basicUdiDi>69449327FU08A01MM</basicUdiDi>
    <tradeName>Wellead Urodynamic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A010810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881152634</udiDi>
    <basicUdiDi>69449327FU08C01MX</basicUdiDi>
    <tradeName>Tube Accessories for Urodynamic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FU08C010210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:28.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881165160</udiDi>
    <basicUdiDi>69449327FU08A02MP</basicUdiDi>
    <tradeName>Wellead Urodynamic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A020610</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:09.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881165177</udiDi>
    <basicUdiDi>69449327FU08C01MX</basicUdiDi>
    <tradeName>Tube Accessories for Urodynamic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FU08C010510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:09.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881165191</udiDi>
    <basicUdiDi>69449327FU08C01MX</basicUdiDi>
    <tradeName>Tube Accessories for Urodynamic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FU08C010810</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:09.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540514028</udiDi>
    <basicUdiDi>85935406TF14URODYNAMIKAAD</basicUdiDi>
    <tradeName>Urodynamická souprava malá USM-S M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606481-03M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T21:13:44.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540514042</udiDi>
    <basicUdiDi>85935406TF14URODYNAMIKAAD</basicUdiDi>
    <tradeName>Urodynamická souprava malá USM M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606481-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T21:13:44.300Z</lastUpdated>
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    <udiDi>00627825001281</udiDi>
    <basicUdiDi>0627825CABA9</basicUdiDi>
    <tradeName>Air-Charged Reusable Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0580</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB4060AS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.529Z</lastUpdated>
  </row>
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    <udiDi>00627825001298</udiDi>
    <basicUdiDi>0627825CABA9</basicUdiDi>
    <tradeName>Air-Charged Reusable Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0580</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB734</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.513Z</lastUpdated>
  </row>
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    <udiDi>00627825001304</udiDi>
    <basicUdiDi>0627825CABA9</basicUdiDi>
    <tradeName>Air-Charged Reusable Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0580</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB4060US</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.498Z</lastUpdated>
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    <udiDi>00627825001311</udiDi>
    <basicUdiDi>0627825CABA9</basicUdiDi>
    <tradeName>Air-Charged Reusable Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0580</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB815</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.477Z</lastUpdated>
  </row>
</eudamedExport>