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<eudamedExport entity="devices">
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    <udiDi>04026704069712</udiDi>
    <basicUdiDi>B-04026704069712</basicUdiDi>
    <tradeName>SoftSimplastic 2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 30ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662530-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:42.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069705</udiDi>
    <basicUdiDi>B-04026704069705</basicUdiDi>
    <tradeName>SoftSimplastic 2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 30ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662530-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:41.869Z</lastUpdated>
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    <udiDi>04026704069699</udiDi>
    <basicUdiDi>B-04026704069699</basicUdiDi>
    <tradeName>SoftSimplastic 2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 30ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662530-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:40.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704022278</udiDi>
    <basicUdiDi>B-24026704022278</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>BRILLANT SILICONE 3W 30ML COUVELAIR</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173930-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:19.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704022261</udiDi>
    <basicUdiDi>B-24026704022261</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>BRILLANT SILICONE 3W 30ML COUVELAIR</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173930-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:15.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704022254</udiDi>
    <basicUdiDi>B-24026704022254</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>BRILLANT SILICONE 3W 20ML COUVELAIR</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173930-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:14.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704022247</udiDi>
    <basicUdiDi>B-24026704022247</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>BRILLANT SILICONE 3W 20ML COUVELAIR</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173930-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:13.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021660</udiDi>
    <basicUdiDi>B-24026704021660</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>PROFILCATH SILICONE 3W 30ML COUVELA</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173230-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:06.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021653</udiDi>
    <basicUdiDi>B-24026704021653</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>PROFILCATH SILICONE 3W 30ML COUVELA</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173230-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:02.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021646</udiDi>
    <basicUdiDi>B-24026704021646</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>PROFILCATH SILICONE 3W 20ML COUVELA</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173230-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:01.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021639</udiDi>
    <basicUdiDi>B-24026704021639</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter, 3 Way with Couvelaire Tip</tradeName>
    <deviceName>PROFILCATH SILICONE 3W 20ML COUVELA</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173230-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:01.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021578</udiDi>
    <basicUdiDi>B-24026704021578</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 2 Way with Couvelaire Tip</tradeName>
    <deviceName>BRLILLANT SILICONE 2W 30ML COUVELAI</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>172530-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:30:00.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021561</udiDi>
    <basicUdiDi>B-24026704021561</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 2 Way with Couvelaire Tip</tradeName>
    <deviceName>BRLILLANT SILICONE 2W 30ML COUVELAI</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>172530-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:29:56.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704021554</udiDi>
    <basicUdiDi>B-24026704021554</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 2 Way with Couvelaire Tip</tradeName>
    <deviceName>BRLILLANT SILICONE 2W 20ML COUVELAI</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>172530-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:29:55.503Z</lastUpdated>
  </row>
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    <udiDi>24026704021547</udiDi>
    <basicUdiDi>B-24026704021547</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter, 2 Way with Couvelaire Tip</tradeName>
    <deviceName>BRLILLANT SILICONE 2W 20ML COUVELAI</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>172530-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:29:54.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555942810176</udiDi>
    <basicUdiDi>B-09555942810176</basicUdiDi>
    <tradeName>CareFlow</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>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01/01/15/24/60</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:26:59.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555942810169</udiDi>
    <basicUdiDi>B-09555942810169</basicUdiDi>
    <tradeName>CareFlow</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>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01/01/15/22/60</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:26:58.997Z</lastUpdated>
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  <row>
    <udiDi>09555942810152</udiDi>
    <basicUdiDi>B-09555942810152</basicUdiDi>
    <tradeName>CareFlow</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>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01/01/15/20/60</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:26:55.505Z</lastUpdated>
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    <udiDi>09555942810145</udiDi>
    <basicUdiDi>B-09555942810145</basicUdiDi>
    <tradeName>CareFlow</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>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01/01/15/18/60</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:26:51.508Z</lastUpdated>
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    <udiDi>09555942808456</udiDi>
    <basicUdiDi>B-09555942808456</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>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3312630</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:25:59.351Z</lastUpdated>
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</eudamedExport>