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    <tradeName>Mycoplasma pneumoniae IgM Antibody Rapid Test Kit</tradeName>
    <deviceName>Mycoplasma pneumoniae IgM Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-016-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:27.587Z</lastUpdated>
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    <udiDi>06974677691790</udiDi>
    <basicUdiDi>B-06974677691790</basicUdiDi>
    <tradeName>Influenza A/B virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Influenza A/B virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-015-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:22.781Z</lastUpdated>
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    <udiDi>06974677691783</udiDi>
    <basicUdiDi>B-06974677691783</basicUdiDi>
    <tradeName>Influenza A/B virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Influenza A/B virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:21.981Z</lastUpdated>
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    <basicUdiDi>B-06974677691776</basicUdiDi>
    <tradeName>Influenza A/B virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Influenza A/B virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-015-5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:21.163Z</lastUpdated>
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    <udiDi>06974677691769</udiDi>
    <basicUdiDi>B-06974677691769</basicUdiDi>
    <tradeName>Influenza A/B virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Influenza A/B virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-015-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:20.367Z</lastUpdated>
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    <udiDi>06974677691714</udiDi>
    <basicUdiDi>B-06974677691714</basicUdiDi>
    <tradeName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</tradeName>
    <deviceName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-010-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:16.366Z</lastUpdated>
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    <basicUdiDi>B-06974677691707</basicUdiDi>
    <tradeName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</tradeName>
    <deviceName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-010-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:15.585Z</lastUpdated>
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    <basicUdiDi>B-06974677691691</basicUdiDi>
    <tradeName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</tradeName>
    <deviceName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-010-5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:14.777Z</lastUpdated>
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    <udiDi>06974677691684</udiDi>
    <basicUdiDi>B-06974677691684</basicUdiDi>
    <tradeName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</tradeName>
    <deviceName>SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-MY-010-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:13.964Z</lastUpdated>
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    <basicUdiDi>B-06974566304091</basicUdiDi>
    <tradeName>NTM Drugs Susceptibility Test Kit</tradeName>
    <deviceName>NTM Drugs Susceptibility Test Kit</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:08.939Z</lastUpdated>
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    <udiDi>06974566304084</udiDi>
    <basicUdiDi>B-06974566304084</basicUdiDi>
    <tradeName>NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM0424</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:04.940Z</lastUpdated>
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    <basicUdiDi>B-06974566304077</basicUdiDi>
    <tradeName>NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM0448</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:04.140Z</lastUpdated>
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    <udiDi>06974566304060</udiDi>
    <basicUdiDi>B-06974566304060</basicUdiDi>
    <tradeName>NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM048</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:03.343Z</lastUpdated>
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    <udiDi>06974566304053</udiDi>
    <basicUdiDi>B-06974566304053</basicUdiDi>
    <tradeName>NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM024</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:02.541Z</lastUpdated>
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    <basicUdiDi>B-06974566304046</basicUdiDi>
    <tradeName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0548</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:58.533Z</lastUpdated>
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    <basicUdiDi>B-06974566304022</basicUdiDi>
    <tradeName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0524</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:57.736Z</lastUpdated>
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    <basicUdiDi>B-06974566304015</basicUdiDi>
    <tradeName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0348</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:56.932Z</lastUpdated>
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    <basicUdiDi>B-06974566304008</basicUdiDi>
    <tradeName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0248</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:56.127Z</lastUpdated>
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    <basicUdiDi>B-06974566303971</basicUdiDi>
    <tradeName>Syphilis Ab Combo Rapid Test</tradeName>
    <deviceName>Syphilis Ab Combo Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSY-40220</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:52.131Z</lastUpdated>
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    <basicUdiDi>B-06974566303995</basicUdiDi>
    <tradeName>(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0224</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:51.334Z</lastUpdated>
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