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    <basicUdiDi>B-06971792053496</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae IgG antibody 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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KJ014</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:39.141Z</lastUpdated>
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    <udiDi>06971792053182</udiDi>
    <basicUdiDi>B-06971792053182</basicUdiDi>
    <tradeName>M.Pneumonia Antigen Rapid Test Device</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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K681416D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:26.644Z</lastUpdated>
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    <udiDi>06971792053151</udiDi>
    <basicUdiDi>B-06971792053151</basicUdiDi>
    <tradeName>M.Pneumonia IgG/IgM Rapid Test Device</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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K670216D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:25.926Z</lastUpdated>
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    <udiDi>06971042229503</udiDi>
    <basicUdiDi>B-06971042229503</basicUdiDi>
    <tradeName>UU/TV/MG Multiplex Real Time PCR Kit</tradeName>
    <deviceName>UU/TV/MG Multiplex Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0316-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:25.800Z</lastUpdated>
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    <udiDi>06971042229480</udiDi>
    <basicUdiDi>B-06971042229480</basicUdiDi>
    <tradeName>Mycoplasma Hominis (MH)  Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Hominis (MH)  Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0279-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:20.694Z</lastUpdated>
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    <udiDi>06971042229473</udiDi>
    <basicUdiDi>B-06971042229473</basicUdiDi>
    <tradeName>Mycoplasma Genitalium (MG)  Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Genitalium (MG)  Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0278-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:19.827Z</lastUpdated>
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    <udiDi>06971042229466</udiDi>
    <basicUdiDi>B-06971042229466</basicUdiDi>
    <tradeName>Ureaplasma parvum (UP) Real Time PCR Kit</tradeName>
    <deviceName>Ureaplasma parvum (UP) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0267-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:18.996Z</lastUpdated>
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    <udiDi>06971042229459</udiDi>
    <basicUdiDi>B-06971042229459</basicUdiDi>
    <tradeName>UU/MH/MG/TV Multiplex Real Time PCR Kit</tradeName>
    <deviceName>UU/MH/MG/TV Multiplex Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0252-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:14.460Z</lastUpdated>
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    <udiDi>06971042229404</udiDi>
    <basicUdiDi>B-06971042229404</basicUdiDi>
    <tradeName>Ureaplasma Urealyticum (UU) Real Time PCR Kit</tradeName>
    <deviceName>Ureaplasma Urealyticum (UU) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0015-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:04:26.575Z</lastUpdated>
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    <udiDi>06971042227677</udiDi>
    <basicUdiDi>B-06971042227677</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae (MP) Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Pneumoniae (MP) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-0100-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:59:32.081Z</lastUpdated>
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    <udiDi>04251557109296</udiDi>
    <basicUdiDi>B-04251557109296</basicUdiDi>
    <tradeName>04251557109296</tradeName>
    <deviceName>Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-03-56</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:47:07.493Z</lastUpdated>
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    <udiDi>04251557109289</udiDi>
    <basicUdiDi>B-04251557109289</basicUdiDi>
    <tradeName>04251557109289</tradeName>
    <deviceName>Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-03-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:47:06.693Z</lastUpdated>
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    <udiDi>04251557109265</udiDi>
    <basicUdiDi>B-04251557109265</basicUdiDi>
    <tradeName>04251557109265</tradeName>
    <deviceName>Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-02-56</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:47:05.888Z</lastUpdated>
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    <udiDi>04251557109234</udiDi>
    <basicUdiDi>B-04251557109234</basicUdiDi>
    <tradeName>04251557109234</tradeName>
    <deviceName>Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-01-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:47:01.141Z</lastUpdated>
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    <udiDi>04251557109241</udiDi>
    <basicUdiDi>B-04251557109241</basicUdiDi>
    <tradeName>04251557109241</tradeName>
    <deviceName>Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-01-56</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:47:00.287Z</lastUpdated>
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    <udiDi>04251557109258</udiDi>
    <basicUdiDi>B-04251557109258</basicUdiDi>
    <tradeName>04251557109258</tradeName>
    <deviceName>Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-02-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:59.490Z</lastUpdated>
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    <udiDi>04251557109227</udiDi>
    <basicUdiDi>B-04251557109227</basicUdiDi>
    <tradeName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-03-56</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:59.414Z</lastUpdated>
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    <udiDi>04251557109210</udiDi>
    <basicUdiDi>B-04251557109210</basicUdiDi>
    <tradeName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-03-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:54.555Z</lastUpdated>
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    <udiDi>04251557109197</udiDi>
    <basicUdiDi>B-04251557109197</basicUdiDi>
    <tradeName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-02-56</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:53.753Z</lastUpdated>
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    <udiDi>04251557109180</udiDi>
    <basicUdiDi>B-04251557109180</basicUdiDi>
    <tradeName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-02-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:52.951Z</lastUpdated>
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