<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-URONOR2SS1610HVTE</udiDi>
    <basicUdiDi>B-URONOR2SS1610HVTE</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheter</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09385-00033-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:41.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1430SVU7</udiDi>
    <basicUdiDi>B-URONOR2SS1430SVU7</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72664-00036-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:40.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1430HVT6</udiDi>
    <basicUdiDi>B-URONOR2SS1430HVT6</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09384-00032-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:40.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1410SVTR</udiDi>
    <basicUdiDi>B-URONOR2SS1410SVTR</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46485-00031-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:39.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1410HVSQ</udiDi>
    <basicUdiDi>B-URONOR2SS1410HVSQ</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09385-00032-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:35.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1230SVTH</udiDi>
    <basicUdiDi>B-URONOR2SS1230SVTH</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72664-00035-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:34.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1230HVSG</udiDi>
    <basicUdiDi>B-URONOR2SS1230HVSG</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09384-00031-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:33.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1210SVT3</udiDi>
    <basicUdiDi>B-URONOR2SS1210SVT3</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46485-00030-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:32.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2SS1210HVS2</udiDi>
    <basicUdiDi>B-URONOR2SS1210HVS2</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09385-00031-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:28.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2PS1005HVQ5</udiDi>
    <basicUdiDi>B-URONOR2PS1005HVQ5</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheter</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09413-00017-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:28.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URONOR2PS0805HVSG</udiDi>
    <basicUdiDi>B-URONOR2PS0805HVSG</basicUdiDi>
    <tradeName>Norta</tradeName>
    <deviceName>Sterile Urethral Latex Foley Balloon Catheters</deviceName>
    <manufacturerName>Uro Technology Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001248</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09413-00016-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:27.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796206750</udiDi>
    <basicUdiDi>69487962NC0002Q6</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020763</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:07:34.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796206767</udiDi>
    <basicUdiDi>69487962NC0002Q6</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020764</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:06:52.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796206774</udiDi>
    <basicUdiDi>69487962NC0002Q6</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020765</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:06:20.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796206781</udiDi>
    <basicUdiDi>69487962NC0002Q6</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020766</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:05:43.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796206798</udiDi>
    <basicUdiDi>69487962NC0002Q6</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020767</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:05:20.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796206804</udiDi>
    <basicUdiDi>69487962NC0002Q6</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020768</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:05:19.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796207856</udiDi>
    <basicUdiDi>69487962TC0002SL</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010602</emdnCode>
    <emdnDescription>TIEMANN CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020306</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:04:10.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796207863</udiDi>
    <basicUdiDi>69487962TC0002SL</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010602</emdnCode>
    <emdnDescription>TIEMANN CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020307</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:04:09.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>16948796207870</udiDi>
    <basicUdiDi>69487962TC0002SL</basicUdiDi>
    <tradeName>Hydrophilic Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bever Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018408</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010602</emdnCode>
    <emdnDescription>TIEMANN CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020308</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:04:08.816Z</lastUpdated>
  </row>
</eudamedExport>