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    <basicUdiDi>B-08683548250445</basicUdiDi>
    <tradeName>RapidFor™ Valproic Acid Rapid Test Kit (FIA)</tradeName>
    <deviceName>Valproic Acid Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:01.802Z</lastUpdated>
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    <udiDi>08683548250384</udiDi>
    <basicUdiDi>B-08683548250384</basicUdiDi>
    <tradeName>RapidFor™ Phenytoin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Phenytoin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO27</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:53.792Z</lastUpdated>
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    <udiDi>08683548250278</udiDi>
    <basicUdiDi>B-08683548250278</basicUdiDi>
    <tradeName>RapidFor™ Carbamazepine Rapid Test Kit (FIA)</tradeName>
    <deviceName>Carbamazepine Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:36.873Z</lastUpdated>
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    <udiDi>06978945081207</udiDi>
    <basicUdiDi>B-06978945081207</basicUdiDi>
    <tradeName>Valproic Acid and Carbamazepine Control</tradeName>
    <deviceName>Valproic Acid and Carbamazepine Control</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBZK905A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:08.005Z</lastUpdated>
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    <udiDi>06978945081184</udiDi>
    <basicUdiDi>B-06978945081184</basicUdiDi>
    <tradeName>Valproic Acid and Carbamazepine Kit(LC-MS/MS)</tradeName>
    <deviceName>Valproic Acid and Carbamazepine Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP905A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:06.420Z</lastUpdated>
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    <udiDi>00884883012714</udiDi>
    <basicUdiDi>B-00884883012714</basicUdiDi>
    <tradeName>00884883012714</tradeName>
    <deviceName>QMS Zonisamide 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>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:15.245Z</lastUpdated>
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    <udiDi>00884883012707</udiDi>
    <basicUdiDi>B-00884883012707</basicUdiDi>
    <tradeName>00884883012707</tradeName>
    <deviceName>QMS Topiramate 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>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:13.643Z</lastUpdated>
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    <udiDi>00884883011298</udiDi>
    <basicUdiDi>B-00884883011298</basicUdiDi>
    <tradeName>00884883011298</tradeName>
    <deviceName>QMS Topiramate 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>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:15.875Z</lastUpdated>
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    <udiDi>00884883011274</udiDi>
    <basicUdiDi>B-00884883011274</basicUdiDi>
    <tradeName>00884883011274</tradeName>
    <deviceName>QMS Lamotrigine Immunoassay (Control)</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>W0102080212</emdnCode>
    <emdnDescription>LAMOTRIGINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:13.464Z</lastUpdated>
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    <udiDi>00884883011267</udiDi>
    <basicUdiDi>B-00884883011267</basicUdiDi>
    <tradeName>00884883011267</tradeName>
    <deviceName>QMS Lamotrigine Immunoassay Calibrator Set</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>W0102080212</emdnCode>
    <emdnDescription>LAMOTRIGINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373787</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:11.867Z</lastUpdated>
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    <udiDi>00884883011250</udiDi>
    <basicUdiDi>B-00884883011250</basicUdiDi>
    <tradeName>00884883011250</tradeName>
    <deviceName>QMS Topiramate Control</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>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:09.466Z</lastUpdated>
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    <udiDi>00884883011236</udiDi>
    <basicUdiDi>B-00884883011236</basicUdiDi>
    <tradeName>00884883011236</tradeName>
    <deviceName>QMS Zonisamide 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>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373381</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:07.067Z</lastUpdated>
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    <udiDi>00884883011229</udiDi>
    <basicUdiDi>B-00884883011229</basicUdiDi>
    <tradeName>00884883011229</tradeName>
    <deviceName>QMS Zonisamide Controls</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>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:05.462Z</lastUpdated>
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    <udiDi>00884883011199</udiDi>
    <basicUdiDi>B-00884883011199</basicUdiDi>
    <tradeName>00884883011199</tradeName>
    <deviceName>QMS Zonisamide Immunoassay</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>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373571</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:01.462Z</lastUpdated>
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    <udiDi>00884883011175</udiDi>
    <basicUdiDi>B-00884883011175</basicUdiDi>
    <tradeName>00884883011175</tradeName>
    <deviceName>QMS Topiramate Immunoassay</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>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:59.063Z</lastUpdated>
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    <udiDi>00884883011168</udiDi>
    <basicUdiDi>B-00884883011168</basicUdiDi>
    <tradeName>00884883011168</tradeName>
    <deviceName>QMS Lamotrigine Immunoassay</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>W0102080212</emdnCode>
    <emdnDescription>LAMOTRIGINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373795</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:56.666Z</lastUpdated>
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    <udiDi>00884883008397</udiDi>
    <basicUdiDi>B-00884883008397</basicUdiDi>
    <tradeName>00884883008397</tradeName>
    <deviceName>ARCHITECT Phenytoin</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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P08-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:14.140Z</lastUpdated>
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    <udiDi>00884883008120</udiDi>
    <basicUdiDi>B-00884883008120</basicUdiDi>
    <tradeName>00884883008120</tradeName>
    <deviceName>Alinity c Carbamazepine Reagent Kit</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P5820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:49.171Z</lastUpdated>
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    <udiDi>00884883008106</udiDi>
    <basicUdiDi>B-00884883008106</basicUdiDi>
    <tradeName>00884883008106</tradeName>
    <deviceName>ARCHITECT Phenobarbital</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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P07-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:45.162Z</lastUpdated>
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    <udiDi>00884883007970</udiDi>
    <basicUdiDi>B-00884883007970</basicUdiDi>
    <tradeName>00884883007970</tradeName>
    <deviceName>ARCHITECT Carbamazepine</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05P05-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:13.892Z</lastUpdated>
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