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    <tradeName>myCROBE Universal Internal Control</tradeName>
    <deviceName>myCROBE Universal Internal Control</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
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    <tradeName>Polyvalent negative control, 1 x 1 mL</tradeName>
    <deviceName>Polyvalent negative control, 1 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
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    <udiDi>D-084360385405406E7</udiDi>
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    <tradeName>Polyvalent positive control, 1 x 1 mL</tradeName>
    <deviceName>Polyvalent positive control, 1 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
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    <tradeName>Quality Control Kit for Logilet STl Panel</tradeName>
    <deviceName>Quality Control Kit for Logilet STl Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC4021</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:03:06.248Z</lastUpdated>
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    <udiDi>06973315739306</udiDi>
    <basicUdiDi>B-06973315739306</basicUdiDi>
    <tradeName>Quality Control Kit for Logilet HPV Panel</tradeName>
    <deviceName>Quality Control Kit for Logilet HPV Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC4011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:03:03.848Z</lastUpdated>
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    <udiDi>03532670503736</udiDi>
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    <tradeName>Control Set for rapid SARS-CoV-2 PCR</tradeName>
    <deviceName>Control set for rapid SARS-CoV-2 PCR</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6150006</reference>
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    <lastUpdated>2026-07-05T13:38:48.325Z</lastUpdated>
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    <basicUdiDi>B-03532670503729</basicUdiDi>
    <tradeName>MALARIA Control</tradeName>
    <deviceName>MALARIA Control</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:43.541Z</lastUpdated>
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    <udiDi>03532670501602</udiDi>
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    <tradeName>Negative control swab</tradeName>
    <deviceName>Negative control swab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:21.055Z</lastUpdated>
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    <tradeName>00884883007321</tradeName>
    <deviceName>AcroMetrix Blue</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>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>969032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:43.575Z</lastUpdated>
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    <udiDi>00884883007307</udiDi>
    <basicUdiDi>B-00884883007307</basicUdiDi>
    <tradeName>00884883007307</tradeName>
    <deviceName>AcroMetrix NATBBV- 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>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>964600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:29.781Z</lastUpdated>
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    <udiDi>00884883007291</udiDi>
    <basicUdiDi>B-00884883007291</basicUdiDi>
    <tradeName>00884883007291</tradeName>
    <deviceName>AcroMetrix HIVRNA+</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>
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    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>961240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:28.196Z</lastUpdated>
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    <udiDi>00884883007277</udiDi>
    <basicUdiDi>B-00884883007277</basicUdiDi>
    <tradeName>00884883007277</tradeName>
    <deviceName>AcroMetrix  HCVRNA+</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>
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    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>961242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:27.400Z</lastUpdated>
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    <udiDi>00884883007253</udiDi>
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    <tradeName>00884883007253</tradeName>
    <deviceName>AcroMetrix HBVDNA+</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>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>961241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:25.788Z</lastUpdated>
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    <deviceName>Acrometrix Multi-Analyte Control HIV/HCV/HBV High</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T09:24:21.780Z</lastUpdated>
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    <deviceName>Acrometrix Multi-Analyte Control HIV/HCV/HBV Low</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>00884883006560</tradeName>
    <deviceName>Acrometrix CT/NG Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>00884883006553</tradeName>
    <deviceName>Acrometrix HBV High Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Acrometrix HIV-1 High Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceName>Acrometrix HCV High Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Acrometrix EV Low Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>960501</reference>
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    <lastUpdated>2026-07-05T09:24:12.994Z</lastUpdated>
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