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    <deviceName>Bacterial McFarland Standard</deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-058930-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:05:54.408Z</lastUpdated>
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    <tradeName>06938010901762</tradeName>
    <deviceName>Bacterial McFarland Standard</deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
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    <tradeName>IVD Bacterical Test Standard</tradeName>
    <deviceName>IVD Bacterical Test Standard</deviceName>
    <manufacturerName>Bruker Daltonics GmbH &amp; Co. KG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:53:20.754Z</lastUpdated>
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    <tradeName>DensiCHEK™ CALIBRATION STANDARD</tradeName>
    <deviceName>DensiCHEK™ CALIBRATION STANDARD</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8309072</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:53:05.433Z</lastUpdated>
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    <tradeName>ATB™ DENSITOMETER CONTROL KIT</tradeName>
    <deviceName>ATB™ DENSITOMETER CONTROL KIT</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15512</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:47:35.342Z</lastUpdated>
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    <udiDi>10845357015829</udiDi>
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    <tradeName>10845357015829</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0670U] KWIK-STIK™ K. rhizophila ATCC 15957™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:21.614Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0669U] KWIK-STIK™ K. rhizophila ATCC 9341a™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:20.816Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0668U] KWIK-STIK™ P. multocida ATCC 12945™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:20.030Z</lastUpdated>
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    <tradeName>10845357015706</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0661U] KWIK-STIK™ E. rhusiopathiae ATCC 19414™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:19.237Z</lastUpdated>
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    <udiDi>10845357015676</udiDi>
    <basicUdiDi>084535700660A4</basicUdiDi>
    <tradeName>10845357015676</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0660U] KWIK-STIK™ T. pyogenes ATCC 19411™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:15.213Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0656U] KWIK-STIK™ S. equi (C) ATCC 9528™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:14.414Z</lastUpdated>
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    <tradeName>10845357015584</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0655U] KWIK-STIK™ B. bronchiseptica ATCC 10580™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:13.616Z</lastUpdated>
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    <basicUdiDi>084535700651A3</basicUdiDi>
    <tradeName>10845357015492</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0651U] KWIK-STIK™ E. durans ATCC 6056™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:12.812Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0650U] KWIK-STIK™ E. hirae ATCC 8043™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:08.803Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0648U] KWIK-STIK™ N. gonorrhoeae ATCC 49226™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:08.005Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0647U] KWIK-STIK™ H. influenzae ATCC 49247™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:07.219Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0646U] KWIK-STIK™ N. lactamica ATCC 49142™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:06.406Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0645U] KWIK-STIK™ A. aphrophilus ATCC 49146™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:02.414Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0644U] KWIK-STIK™ H. influenzae ATCC 49144™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:01.619Z</lastUpdated>
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    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040601</emdnCode>
    <emdnDescription>QC STRAINS BACTERIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0643U] KWIK-STIK™ G. vaginalis ATCC 49145™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:15:00.807Z</lastUpdated>
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