<?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>H67141935070</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4193507</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:24.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>H67141935090</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4193509</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:12.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>H67141950070</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4195007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:08.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>H67141950090</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4195009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:08.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>H67141980050</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4198005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:08.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>H67141980070</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4198009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:08.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>H67141980090</udiDi>
    <basicUdiDi>++H671CE025IIAD4</basicUdiDi>
    <tradeName>Uri-Cath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4198009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:08.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-726893511460JA</udiDi>
    <basicUdiDi>B-726893511460JA</basicUdiDi>
    <tradeName>MyOne</tradeName>
    <deviceName>Non-sterile Non-medicated Natural Rubber Latex Male Condom</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</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>P45S - B55 (45D) XUT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:03:37.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555942811678</udiDi>
    <basicUdiDi>B-09555942811678</basicUdiDi>
    <tradeName>Procare</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>93872660</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:30:15.459Z</lastUpdated>
  </row>
</eudamedExport>