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<eudamedExport entity="devices">
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    <udiDi>08053172972783</udiDi>
    <basicUdiDi>B-08053172972783</basicUdiDi>
    <tradeName>Ferro F - Biotecnica Systems</tradeName>
    <deviceName>Ferro F/Iron F - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010216</emdnCode>
    <emdnDescription>IRON (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0089</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:41.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972776</udiDi>
    <basicUdiDi>B-08053172972776</basicUdiDi>
    <tradeName>CK-MB - Biotecnica Systems</tradeName>
    <deviceName>CK-MB - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0083</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:40.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972769</udiDi>
    <basicUdiDi>B-08053172972769</basicUdiDi>
    <tradeName>Trigliceridi - Biotecnica Systems</tradeName>
    <deviceName>TRIGLICERIDI (Biotecnica)</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0075</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:40.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972752</udiDi>
    <basicUdiDi>B-08053172972752</basicUdiDi>
    <tradeName>Microproteine B - Biotecnica Systems</tradeName>
    <deviceName>Microproteine B/Microproteins B - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0074</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:39.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972721</udiDi>
    <basicUdiDi>B-08053172972721</basicUdiDi>
    <tradeName>Creatinina - Biotecnica Systems</tradeName>
    <deviceName>Creatinina/Creatinine - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:35.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972707</udiDi>
    <basicUdiDi>B-08053172972707</basicUdiDi>
    <tradeName>Proteine Totali - Biotecnica System</tradeName>
    <deviceName>Proteine Totali/Total Proteins - Biotecnica System</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:34.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972684</udiDi>
    <basicUdiDi>B-08053172972684</basicUdiDi>
    <tradeName>Bilirubina Totale - Biotecnica Systems</tradeName>
    <deviceName>Total Bilirubin - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0037</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:33.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972677</udiDi>
    <basicUdiDi>B-08053172972677</basicUdiDi>
    <tradeName>Colesterolo Totale - Biotecnica Systems</tradeName>
    <deviceName>Colesterolo Totale/Cholesterol Total - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:32.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972646</udiDi>
    <basicUdiDi>B-08053172972646</basicUdiDi>
    <tradeName>Calcio Arsenazo - Biotecnica Systems</tradeName>
    <deviceName>Calcio Arsenazo/Calcium Arsenazo - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:28.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972639</udiDi>
    <basicUdiDi>B-08053172972639</basicUdiDi>
    <tradeName>Biotecnica Systems Albumina</tradeName>
    <deviceName>Biotecnica Systems Albumina/Albumin</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:27.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972660</udiDi>
    <basicUdiDi>B-08053172972660</basicUdiDi>
    <tradeName>Bilirubina Diretta - Biotecnica Systems</tradeName>
    <deviceName>Bilirubina Diretta/Direct Bilirubin - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:27.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972653</udiDi>
    <basicUdiDi>B-08053172972653</basicUdiDi>
    <tradeName>Fosforo UV - Biotecnica System</tradeName>
    <deviceName>Fosforo UV/Phosphorus UV - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:26.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972622</udiDi>
    <basicUdiDi>B-08053172972622</basicUdiDi>
    <tradeName>Colesterolo HDL - Biotecnica Systems</tradeName>
    <deviceName>Colesterolo HDL/HDL Cholesterol Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0026</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:09.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972615</udiDi>
    <basicUdiDi>B-08053172972615</basicUdiDi>
    <tradeName>Colesterolo LDL - Biotecnica Systems</tradeName>
    <deviceName>Colesterolo LDL/Cholesterol LDL - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:08.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972608</udiDi>
    <basicUdiDi>B-08053172972608</basicUdiDi>
    <tradeName>Cloruri - Biotecnica Systems</tradeName>
    <deviceName>Cloruri/Chloride - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010304</emdnCode>
    <emdnDescription>CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:07.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972592</udiDi>
    <basicUdiDi>B-08053172972592</basicUdiDi>
    <tradeName>CK-NAC - Biotecnica Systems</tradeName>
    <deviceName>CK-NAC - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0018</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:07.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972585</udiDi>
    <basicUdiDi>B-08053172972585</basicUdiDi>
    <tradeName>Colinesterasi  - Biotecnica Systems</tradeName>
    <deviceName>Colinesterasi/Cholinesterase Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:03.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972561</udiDi>
    <basicUdiDi>B-08053172972561</basicUdiDi>
    <tradeName>Gamma GT -  Biotecnica Systems</tradeName>
    <deviceName>Gamma GT - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:02.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972554</udiDi>
    <basicUdiDi>B-08053172972554</basicUdiDi>
    <tradeName>Gamma GT (IFCC) - Biotecnica Systems</tradeName>
    <deviceName>Gamma GT (IFCC)</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:01.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972547</udiDi>
    <basicUdiDi>B-08053172972547</basicUdiDi>
    <tradeName>LDH-P - Biotecnica Systems</tradeName>
    <deviceName>LDH-P - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010120</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE P ( LDH - P --&gt; L )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-0008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:00.668Z</lastUpdated>
  </row>
</eudamedExport>