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    <tradeName>Opiates (OPI) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KN003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:54:23.155Z</lastUpdated>
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    <udiDi>00884883012554</udiDi>
    <basicUdiDi>B-00884883012554</basicUdiDi>
    <tradeName>00884883012554</tradeName>
    <deviceName>CEDIA Opiate 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10016429</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:31:58.433Z</lastUpdated>
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    <udiDi>00884883011366</udiDi>
    <basicUdiDi>B-00884883011366</basicUdiDi>
    <tradeName>00884883011366</tradeName>
    <deviceName>CEDIA Heroin Metabolite (6-AM) 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>
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    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10015213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:24.683Z</lastUpdated>
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    <udiDi>00884883011113</udiDi>
    <basicUdiDi>B-00884883011113</basicUdiDi>
    <tradeName>00884883011113</tradeName>
    <deviceName>CEDIA Opiate OFT 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014873</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:52.677Z</lastUpdated>
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    <udiDi>00884883008861</udiDi>
    <basicUdiDi>B-00884883008861</basicUdiDi>
    <tradeName>00884883008861</tradeName>
    <deviceName>Alinity c Opiates Semiquant Calibrator 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P6502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:06.981Z</lastUpdated>
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    <udiDi>00884883008854</udiDi>
    <basicUdiDi>B-00884883008854</basicUdiDi>
    <tradeName>00884883008854</tradeName>
    <deviceName>Alinity c Opiates 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P6520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:06.191Z</lastUpdated>
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    <udiDi>00884883008847</udiDi>
    <basicUdiDi>B-00884883008847</basicUdiDi>
    <tradeName>00884883008847</tradeName>
    <deviceName>Alinity c Opiates Qual Calibrator 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P6501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:05.377Z</lastUpdated>
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    <udiDi>00884883008373</udiDi>
    <basicUdiDi>B-00884883008373</basicUdiDi>
    <tradeName>00884883008373</tradeName>
    <deviceName>ARCHITECT Opiates 500 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L34-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:11.740Z</lastUpdated>
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    <udiDi>00884883008366</udiDi>
    <basicUdiDi>B-00884883008366</basicUdiDi>
    <tradeName>00884883008366</tradeName>
    <deviceName>ARCHITECT Opiates 300 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L34-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:10.942Z</lastUpdated>
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    <udiDi>00884883008359</udiDi>
    <basicUdiDi>B-00884883008359</basicUdiDi>
    <tradeName>00884883008359</tradeName>
    <deviceName>ARCHITECT Opiates 150 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L34-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:06.948Z</lastUpdated>
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    <udiDi>00884883008342</udiDi>
    <basicUdiDi>B-00884883008342</basicUdiDi>
    <tradeName>00884883008342</tradeName>
    <deviceName>ARCHITECT Opiates 1000 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L34-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:06.138Z</lastUpdated>
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    <udiDi>00884883008335</udiDi>
    <basicUdiDi>B-00884883008335</basicUdiDi>
    <tradeName>00884883008335</tradeName>
    <deviceName>ARCHITECT Opiates 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L34-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:05.343Z</lastUpdated>
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    <udiDi>00884883005303</udiDi>
    <basicUdiDi>B-00884883005303</basicUdiDi>
    <tradeName>00884883005303</tradeName>
    <deviceName>DRI Opiate Urine Calibrator 3</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:00.007Z</lastUpdated>
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    <udiDi>00884883005297</udiDi>
    <basicUdiDi>B-00884883005297</basicUdiDi>
    <tradeName>00884883005297</tradeName>
    <deviceName>DRI Opiate Urine Calibrator 1</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1609</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:21:58.420Z</lastUpdated>
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    <udiDi>00884883004603</udiDi>
    <basicUdiDi>B-00884883004603</basicUdiDi>
    <tradeName>00884883004603</tradeName>
    <deviceName>DRI Opiate 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:20:19.857Z</lastUpdated>
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    <udiDi>00884883004337</udiDi>
    <basicUdiDi>B-00884883004337</basicUdiDi>
    <tradeName>00884883004337</tradeName>
    <deviceName>CEDUA DAU Opiate 2K</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1815296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:55.054Z</lastUpdated>
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    <udiDi>00884883004306</udiDi>
    <basicUdiDi>B-00884883004306</basicUdiDi>
    <tradeName>00884883004306</tradeName>
    <deviceName>CEDIA Heroin Metabolite (6-AM) 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100186</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:52.636Z</lastUpdated>
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    <udiDi>00884883004269</udiDi>
    <basicUdiDi>B-00884883004269</basicUdiDi>
    <tradeName>00884883004269</tradeName>
    <deviceName>CEDIA Opiate 2K Assay</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100099</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:47.026Z</lastUpdated>
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    <basicUdiDi>B-00884883004245</basicUdiDi>
    <tradeName>00884883004245</tradeName>
    <deviceName>CEDIA Heroin Metabolite (6-AM) Assay</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:39.847Z</lastUpdated>
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    <basicUdiDi>B-00884883004108</basicUdiDi>
    <tradeName>00884883004108</tradeName>
    <deviceName>CEDIA DAU Opiate</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1661248</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:06.966Z</lastUpdated>
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