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<eudamedExport entity="devices">
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    <udiDi>08053172972998</udiDi>
    <basicUdiDi>B-08053172972998</basicUdiDi>
    <tradeName>Bilirubina Totale (DPD) - Biotecnica systems</tradeName>
    <deviceName>Bilirubina Totale/Total Bilirubin (DPD) - 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>BT0034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:28.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972981</udiDi>
    <basicUdiDi>B-08053172972981</basicUdiDi>
    <tradeName>Bilirubina Diretta (DPD) - Biotecnica Systems</tradeName>
    <deviceName>Bilirubina Diretta (DPD) - 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>BT0033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:12.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972974</udiDi>
    <basicUdiDi>B-08053172972974</basicUdiDi>
    <tradeName>RF-Q -Biotecnica Systems</tradeName>
    <deviceName>RF-Q - 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT7733</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:12.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972967</udiDi>
    <basicUdiDi>B-08053172972967</basicUdiDi>
    <tradeName>PCR-Q - Biotecnica Systems</tradeName>
    <deviceName>PCR-Q/CRP-Q - 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT7732</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:10.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972950</udiDi>
    <basicUdiDi>B-08053172972950</basicUdiDi>
    <tradeName>ASO-Q - Biotecnica Systems</tradeName>
    <deviceName>ASO-Q - 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>W01021106</emdnCode>
    <emdnDescription>ANTI-STAPHYLOLYSIN (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT7731</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:07.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972936</udiDi>
    <basicUdiDi>B-08053172972936</basicUdiDi>
    <tradeName>Lipasi - Biotecnica Systems</tradeName>
    <deviceName>Lipasi/Lipase - 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>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT5722</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:06.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972929</udiDi>
    <basicUdiDi>B-08053172972929</basicUdiDi>
    <tradeName>Fruttosamina - Biotecnica Systems</tradeName>
    <deviceName>Fruttosamina/Fructosamine - 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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT5531</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:05.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972912</udiDi>
    <basicUdiDi>B-08053172972912</basicUdiDi>
    <tradeName>Alfa Amilasi - Biotecnica Systems</tradeName>
    <deviceName>Alpha Amylase - 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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT5501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:03.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972905</udiDi>
    <basicUdiDi>B-08053172972905</basicUdiDi>
    <tradeName>ALT/GPT</tradeName>
    <deviceName>ALT/GPT - 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>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4193</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:01.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972899</udiDi>
    <basicUdiDi>B-08053172972899</basicUdiDi>
    <tradeName>Fosfatasi Alcalina - Biotecnica Systems</tradeName>
    <deviceName>Fosfatasi Alcalina (IFCC)/Alkaline Phosphatase (IFCC)</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4183</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:59.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972882</udiDi>
    <basicUdiDi>B-08053172972882</basicUdiDi>
    <tradeName>AST/GOT</tradeName>
    <deviceName>AST/GOT - 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>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4181</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:59.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972875</udiDi>
    <basicUdiDi>B-08053172972875</basicUdiDi>
    <tradeName>Urea UV - Biotecnica Systems</tradeName>
    <deviceName>Urea 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>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4170</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:57.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972868</udiDi>
    <basicUdiDi>B-08053172972868</basicUdiDi>
    <tradeName>Fosfatasi Alcalina (DGKC)</tradeName>
    <deviceName>Fosfatasi Alcalina (DGKC)/Alkaline Phosphatase (DGKC) - 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>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4096</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:55.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972851</udiDi>
    <basicUdiDi>B-08053172972851</basicUdiDi>
    <tradeName>Glucosio - Biotecnica Systems</tradeName>
    <deviceName>Glucosio/Glucose - 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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4057</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:53.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972844</udiDi>
    <basicUdiDi>B-08053172972844</basicUdiDi>
    <tradeName>Acido Urico - Biotecnica Systems</tradeName>
    <deviceName>Acido Urico/Uric Acid - 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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:52.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972837</udiDi>
    <basicUdiDi>B-08053172972837</basicUdiDi>
    <tradeName>Rame - Biotecnica Systems</tradeName>
    <deviceName>Rame/Copper - 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>W01010206</emdnCode>
    <emdnDescription>COPPER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT3119</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:51.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972820</udiDi>
    <basicUdiDi>B-08053172972820</basicUdiDi>
    <tradeName>Magnesio Arsenazo - Biotecnica Systems</tradeName>
    <deviceName>Magnesio Arsenazo/Magnesium 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>W01010306</emdnCode>
    <emdnDescription>MAGNESIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0290</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:49.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972813</udiDi>
    <basicUdiDi>B-08053172972813</basicUdiDi>
    <tradeName>Sodio - Biotecnica Systems</tradeName>
    <deviceName>Sodio/Sodium - 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>W01010309</emdnCode>
    <emdnDescription>SODIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0237</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:49.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972806</udiDi>
    <basicUdiDi>B-08053172972806</basicUdiDi>
    <tradeName>Potassio - Biotecnica Systems</tradeName>
    <deviceName>Potassio/Potassium - 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>W01010308</emdnCode>
    <emdnDescription>POTASSIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0236</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:46.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972790</udiDi>
    <basicUdiDi>B-08053172972790</basicUdiDi>
    <tradeName>Zinco - Biotecnica Systems</tradeName>
    <deviceName>Zinco/Zinc - 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>W01010233</emdnCode>
    <emdnDescription>ZINC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0233</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:48:45.580Z</lastUpdated>
  </row>
</eudamedExport>