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    <tradeName>6-Acetylmorphine Enzyme Immunoassay</tradeName>
    <deviceName>6-Acetylmorphine Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090116</emdnCode>
    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08240035190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:08.294Z</lastUpdated>
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    <udiDi>00630414596105</udiDi>
    <basicUdiDi>0405686901753W2</basicUdiDi>
    <tradeName>Atellica CH Opiates (Op)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_OP_2</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:07.650Z</lastUpdated>
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    <udiDi>00630414596099</udiDi>
    <basicUdiDi>0405686901774WA</basicUdiDi>
    <tradeName>Atellica CH Cannabinoids THC (Thc)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_THC_2</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097503</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:06.062Z</lastUpdated>
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    <udiDi>00630414596082</udiDi>
    <basicUdiDi>0405686901687WE</basicUdiDi>
    <tradeName>Atellica CH Cocaine Metabolite (Coc)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Cocaine Metabolite</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097504</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:04.377Z</lastUpdated>
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    <udiDi>00630414596075</udiDi>
    <basicUdiDi>0405686901668WA</basicUdiDi>
    <tradeName>Atellica CH Benzodiazepines (Bnz)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_BENZ_2</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:02.048Z</lastUpdated>
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  <row>
    <udiDi>00630414596051</udiDi>
    <basicUdiDi>0405686901667W8</basicUdiDi>
    <tradeName>Atellica CH Barbiturates (Brb)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_BARB_2</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090103</emdnCode>
    <emdnDescription>BARBITURATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097507</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:02.041Z</lastUpdated>
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    <udiDi>00630414596044</udiDi>
    <basicUdiDi>0405686901757WA</basicUdiDi>
    <tradeName>Atellica CH Phencyclidine (Pcp)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PCP_2</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097509</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:01.746Z</lastUpdated>
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  <row>
    <udiDi>00630414595955</udiDi>
    <basicUdiDi>0405686901700VD</basicUdiDi>
    <tradeName>Atellica CH Ecstasy (Xtc)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Ecstasy</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090102</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097518</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:46.821Z</lastUpdated>
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  <row>
    <udiDi>00630414595948</udiDi>
    <basicUdiDi>0405686901764W7</basicUdiDi>
    <tradeName>Atellica CH Propoxyphene (Ppx)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PPX_2</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097519</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:46.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595917</udiDi>
    <basicUdiDi>0405686901746W5</basicUdiDi>
    <tradeName>Atellica CH Methadone (Mdn)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_MDN</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:45.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238098</udiDi>
    <basicUdiDi>0405686901754W4</basicUdiDi>
    <tradeName>Atellica CH Oxycodone (OXY)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_OXY</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097541</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:22.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023460</udiDi>
    <basicUdiDi>0405686901098VM</basicUdiDi>
    <tradeName>Emit® II Plus Ecstasy Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Ecstasy 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090102</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445479</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:36.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023415</udiDi>
    <basicUdiDi>0405686901088VJ</basicUdiDi>
    <tradeName>Emit® II Plus Cocaine Metabolite Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Cocaine Metabolite 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:35.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023392</udiDi>
    <basicUdiDi>0405686901066V8</basicUdiDi>
    <tradeName>Emit® II Plus Benzodiazepine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445432</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:34.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023378</udiDi>
    <basicUdiDi>0405686901064V4</basicUdiDi>
    <tradeName>Emit® II Plus Barbiturate Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Barbiturate 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090103</emdnCode>
    <emdnDescription>BARBITURATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:30.490Z</lastUpdated>
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    <udiDi>00842768020315</udiDi>
    <basicUdiDi>0405686901141UV</basicUdiDi>
    <tradeName>Emit II LSD Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_LSD 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090109</emdnCode>
    <emdnDescription>LYSERGIC ACID DIETHYLAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445455</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:04.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768002205</udiDi>
    <basicUdiDi>0405686901149VD</basicUdiDi>
    <tradeName>Emit II Plus Methaqualone Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Methaqualone 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090111</emdnCode>
    <emdnDescription>METHAQUALONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:43.523Z</lastUpdated>
  </row>
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    <udiDi>00842768002182</udiDi>
    <basicUdiDi>0405686901075V9</basicUdiDi>
    <tradeName>Emit II Plus Cannabinoid Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Cannabinoid 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445469</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:43.478Z</lastUpdated>
  </row>
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    <udiDi>00842768001956</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Phencyclidine 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445441</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:36.910Z</lastUpdated>
  </row>
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    <udiDi>00842768001918</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Propoxyphene 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445433</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:36.113Z</lastUpdated>
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</eudamedExport>