<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033772320665</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>Catetere 2AR-12SL / 2AR-12SL Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>2AR-12SL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:50.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772320672</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>2AR-12MX Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>2AR-12MX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:39.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321327</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>2AR-9TE Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>2AR-9TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:06.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772320924</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>Catetere 2AR-12T / 2AR-12T Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>2AR-12T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:51.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321013</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>1AR-5T Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>1AR-5T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:50.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321051</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>2AR-9E Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>2AR-9E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:27.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321211</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>2AR-9TS Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>2AR-9TS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:27.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321396</udiDi>
    <basicUdiDi>803377232CAT-U0504MN</basicUdiDi>
    <tradeName>1AR-5TC Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</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>Piyasada</deviceStatus>
    <reference>1AR-5TC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:01.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850019755180</udiDi>
    <basicUdiDi>B-10850019755180</basicUdiDi>
    <tradeName>Accuryn SmartFoley IAP UO Temp</tradeName>
    <deviceName>Accuryn SmartFoley IAP UO Temp 16Fr - 10 Pack</deviceName>
    <manufacturerName>Potrero Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000033318</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U050402</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGS-06-IAP.16FT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:24.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522452</udiDi>
    <basicUdiDi>B-05060166522452</basicUdiDi>
    <tradeName>05060166522452</tradeName>
    <deviceName>200cm Rectal Poly-Isoprene Balloon Catheter, 4.5 CH</deviceName>
    <manufacturerName>Malvern Medical Developments Ltd also trading as PB Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014481</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U050402</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200045026</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:23:10.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019755183</udiDi>
    <basicUdiDi>B-00850019755183</basicUdiDi>
    <tradeName>Accuryn SmartFoley IAP UO Temp 16Fr</tradeName>
    <deviceName>Accuryn SmartFoley IAP UO Temp 16Fr</deviceName>
    <manufacturerName>Potrero Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000033318</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U050402</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGS-06-IAP.16FT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:24.655Z</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>08032248471030</udiDi>
    <basicUdiDi>8032248471019F</basicUdiDi>
    <tradeName>Securmeter Foley Manometer</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>HM004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:09:11.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248471047</udiDi>
    <basicUdiDi>8032248471019F</basicUdiDi>
    <tradeName>Foley Manometer 6</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>HM006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:09:11.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248471054</udiDi>
    <basicUdiDi>8032248471019F</basicUdiDi>
    <tradeName>Foley Manometer 7</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>HM007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:09:11.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032248471061</udiDi>
    <basicUdiDi>8032248471019F</basicUdiDi>
    <tradeName>Foley Manometer 8</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>HM008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:09:11.910Z</lastUpdated>
  </row>
</eudamedExport>