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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10711433</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:04.201Z</lastUpdated>
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    <udiDi>08806133010532</udiDi>
    <basicUdiDi>880613301053BX</basicUdiDi>
    <tradeName>Chemichroma™</tradeName>
    <deviceName>Chemichroma™</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRR058</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:43:38.881Z</lastUpdated>
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    <tradeName>XL-200 with ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:10.333Z</lastUpdated>
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    <udiDi>08592156143158</udiDi>
    <basicUdiDi>8592156CCIN0050SE</basicUdiDi>
    <tradeName>XL -180 with ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00037</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:09.504Z</lastUpdated>
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    <udiDi>08033622964940</udiDi>
    <basicUdiDi>0803362296494UP</basicUdiDi>
    <tradeName>08033622964940</tradeName>
    <deviceName>BT 1600i</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>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT 1600i</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:29:56.423Z</lastUpdated>
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    <udiDi>00630414014128</udiDi>
    <basicUdiDi>0405686902000UH</basicUdiDi>
    <tradeName>Dimension® EXL™ with LM Integrated Chemistry System</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_EXL 200 w/LM integrated chem system</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10475506</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:24.332Z</lastUpdated>
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    <udiDi>00630414593579</udiDi>
    <basicUdiDi>0405686901015UP</basicUdiDi>
    <tradeName>Dimension® EXL™ 200 Integrated Chemistry System</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_INST_EXL 200 integrated chemistry system</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10636929</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:54.862Z</lastUpdated>
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    <udiDi>00630414523286</udiDi>
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    <tradeName>ADVIA Centaur® CP Immunoassay System</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_INST_CP Immunoassay System</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309710</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:47.643Z</lastUpdated>
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    <udiDi>08592156143851</udiDi>
    <basicUdiDi>8592156CCIN0051SG</basicUdiDi>
    <tradeName>XL-200 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.690Z</lastUpdated>
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    <udiDi>08592156143165</udiDi>
    <basicUdiDi>8592156CCIN0050SE</basicUdiDi>
    <tradeName>XL -180 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.563Z</lastUpdated>
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    <udiDi>03701700860419</udiDi>
    <basicUdiDi>37017008ProS-SeriesW6</basicUdiDi>
    <tradeName>Selectra ProS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.527Z</lastUpdated>
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    <udiDi>03701700864783</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.482Z</lastUpdated>
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    <udiDi>03701700864790</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.459Z</lastUpdated>
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    <udiDi>03701700864806</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-406</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.430Z</lastUpdated>
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    <udiDi>03701700864813</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-407</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.401Z</lastUpdated>
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    <udiDi>03701700864820</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-439</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.376Z</lastUpdated>
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    <udiDi>03701700864837</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-439P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.351Z</lastUpdated>
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    <tradeName>Selectra ProS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-541</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.317Z</lastUpdated>
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    <udiDi>03701700864912</udiDi>
    <basicUdiDi>37017008ProS-SeriesW6</basicUdiDi>
    <tradeName>Selectra ProS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-542</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.293Z</lastUpdated>
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    <udiDi>03701700864929</udiDi>
    <basicUdiDi>37017008ProS-SeriesW6</basicUdiDi>
    <tradeName>Selectra ProS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-543</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.271Z</lastUpdated>
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