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    <deviceName>Glycated hemoglobin calibrator</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
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    <reference>HbA1c</reference>
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    <lastUpdated>2026-07-06T11:49:14.076Z</lastUpdated>
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    <basicUdiDi>B-03610230009062</basicUdiDi>
    <tradeName>ABX Pentra P MultiControl</tradeName>
    <deviceName>ABX Pentra P MultiControl</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-05T14:01:03.674Z</lastUpdated>
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    <udiDi>03610230009055</udiDi>
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    <tradeName>ABX Pentra N MultiControl</tradeName>
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    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
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    <lastUpdated>2026-07-05T14:01:02.859Z</lastUpdated>
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    <deviceName>Urine Dipstick Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>URN5005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:23:51.370Z</lastUpdated>
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    <udiDi>00884883004405</udiDi>
    <basicUdiDi>B-00884883004405</basicUdiDi>
    <tradeName>00884883004405</tradeName>
    <deviceName>MAS® UrichemTRAK Liquid Assayed Urine Control</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:20:07.074Z</lastUpdated>
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    <basicUdiDi>B-00884883004160</basicUdiDi>
    <tradeName>00884883004160</tradeName>
    <deviceName>MAS Urinalysis Liquid Urinalysis Control 3</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>024227</reference>
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    <lastUpdated>2026-07-05T09:19:18.970Z</lastUpdated>
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    <basicUdiDi>B-00884883004153</basicUdiDi>
    <tradeName>00884883004153</tradeName>
    <deviceName>MAS Urinalysis Liquid Urinalysis Control 3</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>024224</reference>
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    <lastUpdated>2026-07-05T09:19:14.961Z</lastUpdated>
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    <basicUdiDi>B-00884883004146</basicUdiDi>
    <tradeName>00884883004146</tradeName>
    <deviceName>MAS Urinalysis Liquid Urinalysis Control 1</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T09:19:14.166Z</lastUpdated>
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    <udiDi>00884883004139</udiDi>
    <basicUdiDi>B-00884883004139</basicUdiDi>
    <tradeName>00884883004139</tradeName>
    <deviceName>MAS Urinalysis Liquid Urinalysis Control 1</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>024222</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:13.365Z</lastUpdated>
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    <udiDi>00884883003958</udiDi>
    <basicUdiDi>B-00884883003958</basicUdiDi>
    <tradeName>00884883003958</tradeName>
    <deviceName>MAS® UA DipTube Liquid Assayed Urinalysis 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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAT-MP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:00.550Z</lastUpdated>
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    <udiDi>00884883003934</udiDi>
    <basicUdiDi>B-00884883003934</basicUdiDi>
    <tradeName>00884883003934</tradeName>
    <deviceName>MAS UA Control Liquid Assayed Urinalysis 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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAB-MP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:59.751Z</lastUpdated>
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    <udiDi>00884883003927</udiDi>
    <basicUdiDi>B-00884883003927</basicUdiDi>
    <tradeName>00884883003927</tradeName>
    <deviceName>MAS UA Control Liquid Assayed Urinalysis 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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAB-260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:58.953Z</lastUpdated>
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    <udiDi>00884883003910</udiDi>
    <basicUdiDi>B-00884883003910</basicUdiDi>
    <tradeName>00884883003910</tradeName>
    <deviceName>MAS UA Control Liquid Assayed Urinalysis Control</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAB-215</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:55.048Z</lastUpdated>
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    <udiDi>00884883003903</udiDi>
    <basicUdiDi>B-00884883003903</basicUdiDi>
    <tradeName>00884883003903</tradeName>
    <deviceName>MAS UA Control Liquid Assayed Urinalysis Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAB-160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:53.372Z</lastUpdated>
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    <deviceName>MAS UA Control Liquid Assayed Urinalysis Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:52.552Z</lastUpdated>
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    <tradeName>00884883002494</tradeName>
    <deviceName>MAS® UrichemTRAK Liquid Assayed Urine Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>UR-MP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:03.594Z</lastUpdated>
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    <basicUdiDi>B-00884883002487</basicUdiDi>
    <tradeName>00884883002487</tradeName>
    <deviceName>MAS® UrichemTRAK Liquid Assayed Urine Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <lastUpdated>2026-07-05T09:15:01.991Z</lastUpdated>
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    <tradeName>00884883002470</tradeName>
    <deviceName>MAS® UrichemTRAK Liquid Assayed Urine Control</deviceName>
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    <lastUpdated>2026-07-05T09:14:59.598Z</lastUpdated>
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    <basicUdiDi>B-00859110005920</basicUdiDi>
    <tradeName>VALIDATE® SP3 Test Set</tradeName>
    <deviceName>VALIDATE® SP3 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
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    <tradeName>VALIDATE® SP2 Test Set</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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