<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060166522520</udiDi>
    <basicUdiDi>B-05060166522520</basicUdiDi>
    <tradeName>05060166522520</tradeName>
    <deviceName>70cm Double Lumen Cystometry Catheter, 6 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>U05010101</emdnCode>
    <emdnDescription>CYSTOMANOMETRY CATHETERS, WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100060027</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:29.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522506</udiDi>
    <basicUdiDi>B-05060166522506</basicUdiDi>
    <tradeName>05060166522506</tradeName>
    <deviceName>385mm Bladder Filling Catheter 10CH</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>U050199</emdnCode>
    <emdnDescription>CYSTOMANOMETRY AND URETHROMANOMETRY CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100100001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:26.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522490</udiDi>
    <basicUdiDi>B-05060166522490</basicUdiDi>
    <tradeName>05060166522490</tradeName>
    <deviceName>385mm Bladder Filling Catheter, 8 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>U050199</emdnCode>
    <emdnDescription>CYSTOMANOMETRY AND URETHROMANOMETRY CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100080001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:25.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522483</udiDi>
    <basicUdiDi>B-05060166522483</basicUdiDi>
    <tradeName>05060166522483</tradeName>
    <deviceName>200cm Rectal Poly-Isoprene Balloon Catheter with Introducer, 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>200045028</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:24.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522476</udiDi>
    <basicUdiDi>B-05060166522476</basicUdiDi>
    <tradeName>05060166522476</tradeName>
    <deviceName>40cm Double Lumen Rectal PVC Balloon Catheter, 10 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>200100003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:22.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522469</udiDi>
    <basicUdiDi>B-05060166522469</basicUdiDi>
    <tradeName>05060166522469</tradeName>
    <deviceName>200cm Rectal PVC Balloon Catheter with Introducer, 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>200045027</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:19.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522445</udiDi>
    <basicUdiDi>B-05060166522445</basicUdiDi>
    <tradeName>05060166522445</tradeName>
    <deviceName>Pump Tube Set (MMS Solar)</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>U0580</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400120037</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:17.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522438</udiDi>
    <basicUdiDi>B-05060166522438</basicUdiDi>
    <tradeName>05060166522438</tradeName>
    <deviceName>40cm Double Lumen Rectal Poly-Isoprene Balloon Catheter, 10 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>200100007</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:17.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166522421</udiDi>
    <basicUdiDi>B-05060166522421</basicUdiDi>
    <tradeName>05060166522421</tradeName>
    <deviceName>200cm Rectal PVC 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>200045025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:15.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521707</udiDi>
    <basicUdiDi>B-05060166521707</basicUdiDi>
    <tradeName>05060166521707</tradeName>
    <deviceName>10fg Double Lumen PVC Balloon Catheter</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>200100015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:11.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521684</udiDi>
    <basicUdiDi>B-05060166521684</basicUdiDi>
    <tradeName>05060166521684</tradeName>
    <deviceName>4.5fg Rectal Poly-Isoprene Balloon Catheter with Introducer</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>200045017</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:10.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521660</udiDi>
    <basicUdiDi>B-05060166521660</basicUdiDi>
    <tradeName>05060166521660</tradeName>
    <deviceName>4.5fg Rectal Catheter with PVC Balloon and Introducer</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>200045010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:09.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521646</udiDi>
    <basicUdiDi>B-05060166521646</basicUdiDi>
    <tradeName>05060166521646</tradeName>
    <deviceName>Rectal Catheter with PVC Non-Return Valve, 4.5fg</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>U050401</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITHOUT BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200045003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:06.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521622</udiDi>
    <basicUdiDi>B-05060166521622</basicUdiDi>
    <tradeName>05060166521622</tradeName>
    <deviceName>4.5fg Rectal Catheter with PVC Balloon</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>200045001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:05.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521608</udiDi>
    <basicUdiDi>B-05060166521608</basicUdiDi>
    <tradeName>05060166521608</tradeName>
    <deviceName>10fg Double Lumen UPP Catheter with Y-Connector</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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100100011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:03.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521561</udiDi>
    <basicUdiDi>B-05060166521561</basicUdiDi>
    <tradeName>05060166521561</tradeName>
    <deviceName>8fg Double Lumen UPP Catheter with Y-Connector and Tiemann Tip</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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100080031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:01.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521509</udiDi>
    <basicUdiDi>B-05060166521509</basicUdiDi>
    <tradeName>05060166521509</tradeName>
    <deviceName>6fg Double Lumen UPP Catheter with Y-Connector</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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100060018</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:55:59.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521547</udiDi>
    <basicUdiDi>B-05060166521547</basicUdiDi>
    <tradeName>05060166521547</tradeName>
    <deviceName>8fg Double Lumen UPP Catheter with Y-Connector</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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100080005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:55:57.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521523</udiDi>
    <basicUdiDi>B-05060166521523</basicUdiDi>
    <tradeName>05060166521523</tradeName>
    <deviceName>Double Lumen Cystometry Catheter, 8Fr</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>U05010101</emdnCode>
    <emdnDescription>CYSTOMANOMETRY CATHETERS, WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100080003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:55:56.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166521486</udiDi>
    <basicUdiDi>B-05060166521486</basicUdiDi>
    <tradeName>05060166521486</tradeName>
    <deviceName>Double Lumen Cystometry Catheter, 6fr</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>U05010101</emdnCode>
    <emdnDescription>CYSTOMANOMETRY CATHETERS, WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100060008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:55:54.707Z</lastUpdated>
  </row>
</eudamedExport>