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    <tradeName>BT 1500i</tradeName>
    <deviceName>ANALIZZATORE CHIM-CLIN. BT 1500i</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <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 1500i</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:43.630Z</lastUpdated>
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    <udiDi>08033622964186</udiDi>
    <basicUdiDi>0803362296418U7</basicUdiDi>
    <tradeName>BT15i</tradeName>
    <deviceName>BT15i</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT15i</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:41.206Z</lastUpdated>
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    <udiDi>08033622964148</udiDi>
    <basicUdiDi>0803362296414TX</basicUdiDi>
    <tradeName>CB250-B-G</tradeName>
    <deviceName>CB250-B-G</deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <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>CB250-B-G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:37.202Z</lastUpdated>
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    <udiDi>08033622963608</udiDi>
    <basicUdiDi>0803362296360TZ</basicUdiDi>
    <tradeName>BT 1500</tradeName>
    <deviceName>BT 1500-A-A</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 1500-A-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:36.415Z</lastUpdated>
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    <udiDi>08033622963592</udiDi>
    <basicUdiDi>0803362296359UG</basicUdiDi>
    <tradeName>AUTOLYSER</tradeName>
    <deviceName>AUTOLYSER</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>AUTOLYSER</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:35.613Z</lastUpdated>
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    <udiDi>08033622963585</udiDi>
    <basicUdiDi>0803362296358UE</basicUdiDi>
    <tradeName>BT 1500</tradeName>
    <deviceName>BT 1500</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 1500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:34.809Z</lastUpdated>
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    <udiDi>08033622963523</udiDi>
    <basicUdiDi>0803362296394UJ</basicUdiDi>
    <tradeName>08033622963523</tradeName>
    <deviceName>BT35i</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>AB pazarı için değil</deviceStatus>
    <reference>BT35i</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:30.803Z</lastUpdated>
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  <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>
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  <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>
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  <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>
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  <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>G3202301</udiDi>
    <basicUdiDi>++G320ABA06QL</basicUdiDi>
    <tradeName>ALTA Biochemistry Analyzer</tradeName>
    <deviceName>ALTA Biochemistry Analyzer</deviceName>
    <manufacturerName>Athenese-Dx Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000031022</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>ADX-230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:35:59.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>EABA11000000EI1</udiDi>
    <basicUdiDi>++EABA11000000EI5D</basicUdiDi>
    <tradeName>Piccolo Xpress</tradeName>
    <deviceName>Piccolo Xpress chemistry analyzer, Europe, Italian Pharmacies</deviceName>
    <manufacturerName>Abaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021651</manufacturerSrn>
    <authorisedRepresentativeName>ABAXIS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000017984</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>1100-0000EI</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:55:17.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>EABA11000000E1</udiDi>
    <basicUdiDi>++EABA11000000E7F</basicUdiDi>
    <tradeName>Piccolo Xpress</tradeName>
    <deviceName>Piccolo Xpress chemistry analyzer</deviceName>
    <manufacturerName>Abaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021651</manufacturerSrn>
    <authorisedRepresentativeName>ABAXIS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000017984</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>1100-0000E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:55:13.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EABA11000000ER1</udiDi>
    <basicUdiDi>++EABA11000000ER5X</basicUdiDi>
    <tradeName>Piccolo Xpress</tradeName>
    <deviceName>Piccolo Xpress chemistry analyzer, recertified</deviceName>
    <manufacturerName>Abaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021651</manufacturerSrn>
    <authorisedRepresentativeName>ABAXIS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000017984</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>1100-0000ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:46:21.988Z</lastUpdated>
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  <row>
    <udiDi>D-ChemistryAnalyzerHC</udiDi>
    <basicUdiDi>B-ChemistryAnalyzerHC</basicUdiDi>
    <tradeName>NS BIOTEC Chemistry Analyzer</tradeName>
    <deviceName>NS BIOTEC Chemistry Analyzer</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SCA 1000/1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:15.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-18306GC</udiDi>
    <basicUdiDi>B-18306GC</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName>SPOTCHEM EZ (SP-4430)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18306</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:28:11.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-18304G8</udiDi>
    <basicUdiDi>B-18304G8</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName>SPOTCHEM EZ (SP-4430)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:28:10.121Z</lastUpdated>
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  <row>
    <udiDi>D-105581MS</udiDi>
    <basicUdiDi>B-105581MS</basicUdiDi>
    <tradeName>The Lab 004 (DB-3910)</tradeName>
    <deviceName>The Lab 004 (DB-3910)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105581</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:30.183Z</lastUpdated>
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  <row>
    <udiDi>05907514601660</udiDi>
    <basicUdiDi>59075146AccentS120TW</basicUdiDi>
    <tradeName>Chemistry Analyzer Model: ACCENT S120</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B04-A0002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:37:24.204Z</lastUpdated>
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