<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033622963363</udiDi>
    <basicUdiDi>0803362296336U4</basicUdiDi>
    <tradeName>08033622963363</tradeName>
    <deviceName>BT 3500</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT 3500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:29.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622963264</udiDi>
    <basicUdiDi>0803362296326TZ</basicUdiDi>
    <tradeName>BT 3000 PLUS SENZA ISE</tradeName>
    <deviceName>BT 3000 P S/I</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT 3000 P S/I</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:29.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622963448</udiDi>
    <basicUdiDi>0803362296435U7</basicUdiDi>
    <tradeName>BT 3500 S/ISE-TS</tradeName>
    <deviceName>BT 3500 S/I</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT 3500 S/I-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:28.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622963219</udiDi>
    <basicUdiDi>0803362296321TP</basicUdiDi>
    <tradeName>08033622963219</tradeName>
    <deviceName>ANALIZZATORE CHIM-CLIN BT 3000 PLUS</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT 3000 PLUS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:13.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962816</udiDi>
    <basicUdiDi>803362296281BF</basicUdiDi>
    <tradeName>CV% SOLUTION</tradeName>
    <deviceName>CV% SOLUTION</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>390C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:43.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962809</udiDi>
    <basicUdiDi>803362296280BD</basicUdiDi>
    <tradeName>FCC SOLUTION TARGA</tradeName>
    <deviceName>FCC SOLUTION TARGA</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>390</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:42.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962717</udiDi>
    <basicUdiDi>803362296271BC</basicUdiDi>
    <tradeName>SOLUZIONE CLEANING</tradeName>
    <deviceName>SOLUZIONE CLEANING</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:38.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962731</udiDi>
    <basicUdiDi>803362296273BG</basicUdiDi>
    <tradeName>SOLUZIONE DI LAVAGGIO</tradeName>
    <deviceName>SOLUZIONE DI LAVAGGIO</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395W</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:37.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962724</udiDi>
    <basicUdiDi>803362296272BE</basicUdiDi>
    <tradeName>SOLUZIONE DETERGENTE</tradeName>
    <deviceName>SOLUZIONE DETERGENTE</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:36.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962700</udiDi>
    <basicUdiDi>803362296270BA</basicUdiDi>
    <tradeName>TENSIOATTIVO</tradeName>
    <deviceName>TENSIOATTIVO</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>392T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:21.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962656</udiDi>
    <basicUdiDi>803362296265BH</basicUdiDi>
    <tradeName>DETERG. CAMERA MISCELAZIONE</tradeName>
    <deviceName>DETERG. CAMERA MISCELAZIONE</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:19.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962427</udiDi>
    <basicUdiDi>803362296242B5</basicUdiDi>
    <tradeName>SOLUZIONE LAVAGGIO I.S.E.</tradeName>
    <deviceName>SOLUZIONE LAVAGGIO I.S.E.</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:18.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962403</udiDi>
    <basicUdiDi>803362296240AZ</basicUdiDi>
    <tradeName>I.S.E. BUFFER CONC.</tradeName>
    <deviceName>I.S.E. BUFFER CONC.</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:17.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962380</udiDi>
    <basicUdiDi>803362296243B7</basicUdiDi>
    <tradeName>SOLUZ. ENZIMATICA LAVAG. I.S.E.</tradeName>
    <deviceName>SOLUZIONE ENZIMATICA I.S.E.</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>945</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:13.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962182</udiDi>
    <basicUdiDi>803362296218B8</basicUdiDi>
    <tradeName>NA CONDITIONING SOLUTION</tradeName>
    <deviceName>NA CONDITIONING SOLUTION</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>933G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:12.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962168</udiDi>
    <basicUdiDi>803362296216B4</basicUdiDi>
    <tradeName>I.S.E. Sample Diluent</tradeName>
    <deviceName>I.S.E. Sample Diluent</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>935</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:03:11.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962229</udiDi>
    <basicUdiDi>803362296218B8</basicUdiDi>
    <tradeName>SODIUM CONDITIONING SOLUTION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>933D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962410</udiDi>
    <basicUdiDi>803362296240AZ</basicUdiDi>
    <tradeName>I.S.E. REFERENCE CONC.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962434</udiDi>
    <basicUdiDi>803362296243B7</basicUdiDi>
    <tradeName>SOLUZIONE ENZIMATICA I.S.E.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962441</udiDi>
    <basicUdiDi>803362296240AZ</basicUdiDi>
    <tradeName>I.S.E. REFERENCE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.822Z</lastUpdated>
  </row>
</eudamedExport>