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<eudamedExport entity="devices">
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    <udiDi>08056351100021</udiDi>
    <basicUdiDi>B-08056351100021</basicUdiDi>
    <tradeName>RAD-INJECT β</tradeName>
    <deviceName>RAD-INJECT β</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351010009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:27:29.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100014</udiDi>
    <basicUdiDi>B-08056351100014</basicUdiDi>
    <tradeName>RAD-INJECT γ</tradeName>
    <deviceName>RAD-INJECT γ</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351010008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:27:27.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100144</udiDi>
    <basicUdiDi>8056351100000STASTERJK</basicUdiDi>
    <tradeName>ASTER STAND</tradeName>
    <deviceName>ASTER STAND</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030380</emdnCode>
    <emdnDescription>INFUSION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>357010313</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:15:06.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100120</udiDi>
    <basicUdiDi>8056351100000KARL2.0ZJ</basicUdiDi>
    <tradeName>KARL100 2.0</tradeName>
    <deviceName>KARL 100 2.0</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11029005</emdnCode>
    <emdnDescription>AUTOMATIC DOSE CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135000054</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:15:04.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100076</udiDi>
    <basicUdiDi>80563511000000STKARL2R</basicUdiDi>
    <tradeName>KARL STAND</tradeName>
    <deviceName>KARL STAND</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030380</emdnCode>
    <emdnDescription>INFUSION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>348000006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:15:02.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100045</udiDi>
    <basicUdiDi>80563511000000STRADB2C</basicUdiDi>
    <tradeName>RAD-INJECT β STAND</tradeName>
    <deviceName>RAD-INJECT β STAND</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030380</emdnCode>
    <emdnDescription>INFUSION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351010004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:15:00.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100038</udiDi>
    <basicUdiDi>80563511000000STRADG2N</basicUdiDi>
    <tradeName>RAD-INJECT γ STAND</tradeName>
    <deviceName>RAD-INJECT γ STAND</deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030380</emdnCode>
    <emdnDescription>INFUSION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351010002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:14:58.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056351100052</udiDi>
    <basicUdiDi>80563511000000STRADG2N</basicUdiDi>
    <tradeName>RAD-INJECT γ  WALL MOUNT STAND</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tema Sinergie S.p.a.</manufacturerName>
    <manufacturerSrn>IT-MF-000027196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030380</emdnCode>
    <emdnDescription>INFUSION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351010007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:56:38.212Z</lastUpdated>
  </row>
</eudamedExport>