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    <basicUdiDi>0405686901227V8</basicUdiDi>
    <tradeName>Emit tox Acetaminophen Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Assay</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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445385</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:53.107Z</lastUpdated>
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    <udiDi>00842768005787</udiDi>
    <basicUdiDi>0405686900208UV</basicUdiDi>
    <tradeName>Dimension Acetaminophen Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_ACTM</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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444916</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:31.345Z</lastUpdated>
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    <udiDi>00630414595894</udiDi>
    <basicUdiDi>0405686900811VG</basicUdiDi>
    <tradeName>Atellica CH Acetaminophen (Acet)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_ACET</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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097522</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:43.340Z</lastUpdated>
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    <udiDi>00842768023330</udiDi>
    <basicUdiDi>0405686901227V8</basicUdiDi>
    <tradeName>Emit® tox™ Acetaminophen Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Assay</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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:13.674Z</lastUpdated>
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  <row>
    <udiDi>D-472169QF</udiDi>
    <basicUdiDi>B-472169QF</basicUdiDi>
    <tradeName>Acetaminophen Reagent (ACTM 100)</tradeName>
    <deviceName>Acetaminophen Reagent (ACTM 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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472169</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:50.333Z</lastUpdated>
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    <udiDi>06974473302951</udiDi>
    <basicUdiDi>B-06974473302951</basicUdiDi>
    <tradeName>APAP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>APAP Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:31.020Z</lastUpdated>
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    <udiDi>00884883001176</udiDi>
    <basicUdiDi>B-00884883001176</basicUdiDi>
    <tradeName>00884883001176</tradeName>
    <deviceName>DRI Acetaminophen Serum Tox Calibrator</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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:59.351Z</lastUpdated>
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    <udiDi>00884883001169</udiDi>
    <basicUdiDi>B-00884883001169</basicUdiDi>
    <tradeName>00884883001169</tradeName>
    <deviceName>DRI Acetaminophen Serum Tox 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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1086</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:56.957Z</lastUpdated>
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  <row>
    <udiDi>06952804817305</udiDi>
    <basicUdiDi>B-06952804817305</basicUdiDi>
    <tradeName>Acetaminophen</tradeName>
    <deviceName>Acetaminophen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACE-U11, ACE-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:56.554Z</lastUpdated>
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