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<eudamedExport entity="devices">
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    <udiDi>08806103800101</udiDi>
    <basicUdiDi>880610380010CB</basicUdiDi>
    <tradeName>HYALFORTE INJECTION</tradeName>
    <deviceName>HYALFORTE INJECTION</deviceName>
    <manufacturerName>Shin poong Pharm Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009206</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPP-B2HPA03T-2201</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:38:05.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682874230039</udiDi>
    <basicUdiDi>B-08682874230039</basicUdiDi>
    <tradeName>HYADEX</tradeName>
    <deviceName>INJECTABLE GEL FOR TREATMENTS OF VESICOURETERAL REFLUX (VUR)</deviceName>
    <manufacturerName>Ekspo Farma İlaç Medi̇kal San. ve Ti̇c. Ltd. Şti̇.</manufacturerName>
    <manufacturerSrn>TR-MF-000040218</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKS-03</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:19:35.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682874230022</udiDi>
    <basicUdiDi>B-08682874230022</basicUdiDi>
    <tradeName>DEXSUI</tradeName>
    <deviceName>INJECTABLE GEL FOR TREATMENTS OF STRESS URINARY INCONTINENCE (SUI)</deviceName>
    <manufacturerName>Ekspo Farma İlaç Medi̇kal San. ve Ti̇c. Ltd. Şti̇.</manufacturerName>
    <manufacturerSrn>TR-MF-000040218</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKS-02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:19:34.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682874230015</udiDi>
    <basicUdiDi>B-08682874230015</basicUdiDi>
    <tradeName>DEXVUR</tradeName>
    <deviceName>INJECTABLE GEL FOR TREATMENTS OF VESICOURETERAL REFLUX (VUR)</deviceName>
    <manufacturerName>Ekspo Farma İlaç Medi̇kal San. ve Ti̇c. Ltd. Şti̇.</manufacturerName>
    <manufacturerSrn>TR-MF-000040218</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKS-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:19:32.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903193</udiDi>
    <basicUdiDi>890209590315GJ</basicUdiDi>
    <tradeName>Prefilled Syringe with 0.9% Saline Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90319</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:49:51.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056999190552</udiDi>
    <basicUdiDi>805699919FULL-PTV02WT</basicUdiDi>
    <tradeName>EVOKIT FULL PICC</tradeName>
    <deviceName>EVOKIT FULL PICC</deviceName>
    <manufacturerName>GADA ITALIA S.P.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000045332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FULL-PTV02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:05.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843756</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Leovisc 2% (1 siringa preriempita)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:26.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843688</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Introx 2% (3 siringhe preriempite)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:25.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843664</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Jesitrox 2%  (3 siringhe preriempite)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:23.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843657</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Jesitrox 2% (1 siringa preriempita)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:17.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843640</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Ilatrox 2% (3 siringhe preriempite)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:16.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843527</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Artox 1.6% (3 prefilled syringes)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:14.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748843510</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Artox 1.6% (1 prefilled syringe)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:13.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748841431</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Ilatrox 2% (1 siringa preriempita)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:07.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748841042</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Artox 2% (3 prefilled syringes)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:06.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055748840779</udiDi>
    <basicUdiDi>805574884FTMDR74YE</basicUdiDi>
    <tradeName>Artox 2% (1 prefilled syringe)</tradeName>
    <deviceName>ARTOX 2% (1 siringa preriempita)</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.CE.74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:07:05.369Z</lastUpdated>
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  <row>
    <udiDi>07640164440293</udiDi>
    <basicUdiDi>B-07640164440293</basicUdiDi>
    <tradeName>HEALAFLOW</tradeName>
    <deviceName>HEALAFLOW</deviceName>
    <manufacturerName>Aptissen SA</manufacturerName>
    <manufacturerSrn>CH-MF-000019305</manufacturerSrn>
    <authorisedRepresentativeName>APTISSEN FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000010350</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-HEA060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:10:21.534Z</lastUpdated>
  </row>
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    <udiDi>07640164440217</udiDi>
    <basicUdiDi>B-07640164440217</basicUdiDi>
    <tradeName>SYNOLIS VA 80/160</tradeName>
    <deviceName>SYNOLIS VA 80/160</deviceName>
    <manufacturerName>Aptissen SA</manufacturerName>
    <manufacturerSrn>CH-MF-000019305</manufacturerSrn>
    <authorisedRepresentativeName>APTISSEN FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000010350</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-SYN400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:10:20.347Z</lastUpdated>
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    <udiDi>07640164440163</udiDi>
    <basicUdiDi>B-07640164440163</basicUdiDi>
    <tradeName>SYNOLIS VA 40/80</tradeName>
    <deviceName>SYNOLIS VA 40/80</deviceName>
    <manufacturerName>Aptissen SA</manufacturerName>
    <manufacturerSrn>CH-MF-000019305</manufacturerSrn>
    <authorisedRepresentativeName>APTISSEN FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000010350</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-SYN200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:10:19.138Z</lastUpdated>
  </row>
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    <udiDi>07640164440156</udiDi>
    <basicUdiDi>B-07640164440156</basicUdiDi>
    <tradeName>HEALAVIS Classic 1%</tradeName>
    <deviceName>HEALAVIS Classic 1%</deviceName>
    <manufacturerName>Aptissen SA</manufacturerName>
    <manufacturerSrn>CH-MF-000019305</manufacturerSrn>
    <authorisedRepresentativeName>APTISSEN FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000010350</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-VIS1.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:10:17.939Z</lastUpdated>
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</eudamedExport>