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    <tradeName>Atellica CH Tobramycin (Tob)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_TOB</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097517</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:47.619Z</lastUpdated>
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    <tradeName>Dimension Tobramycin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TOBR</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 C</riskClass>
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    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444928</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Emit 2000 Tobramycin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
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    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-15T21:27:56.858Z</lastUpdated>
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    <udiDi>D-467983S9</udiDi>
    <basicUdiDi>B-467983S9</basicUdiDi>
    <tradeName>Tobramycin Reagent (TOB 2 x 100)</tradeName>
    <deviceName>Tobramycin Reagent (TOB 2 x 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467983</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:36.222Z</lastUpdated>
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    <udiDi>00884883012691</udiDi>
    <basicUdiDi>B-00884883012691</basicUdiDi>
    <tradeName>00884883012691</tradeName>
    <deviceName>QMS Tobramycin Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:11.252Z</lastUpdated>
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    <basicUdiDi>B-00884883011328</basicUdiDi>
    <tradeName>00884883011328</tradeName>
    <deviceName>QMS Tobramycin Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:18.272Z</lastUpdated>
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    <tradeName>00884883008946</tradeName>
    <deviceName>Alinity c Tobramycin Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P9001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:19.016Z</lastUpdated>
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    <tradeName>00884883008939</tradeName>
    <deviceName>Alinity c Tobramycin Reagent Kit</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P9020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:14.996Z</lastUpdated>
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    <basicUdiDi>B-00884883008465</basicUdiDi>
    <tradeName>00884883008465</tradeName>
    <deviceName>ARCHITECT Tobramycin Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7F93-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:25.358Z</lastUpdated>
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    <udiDi>00884883008458</udiDi>
    <basicUdiDi>B-00884883008458</basicUdiDi>
    <tradeName>00884883008458</tradeName>
    <deviceName>ARCHITECT Tobramycin Reagent</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7F93-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:24.545Z</lastUpdated>
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    <udiDi>00884883005631</udiDi>
    <basicUdiDi>B-00884883005631</basicUdiDi>
    <tradeName>00884883005631</tradeName>
    <deviceName>CEDIA Tobramycin II</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:52.094Z</lastUpdated>
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    <udiDi>00842768023309</udiDi>
    <basicUdiDi>0405686901203US</basicUdiDi>
    <tradeName>Emit® 2000 Tobramycin Assay</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:16.254Z</lastUpdated>
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