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    <basicUdiDi>B-08684387210195</basicUdiDi>
    <tradeName>RevoDx Respiratory-24 Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Respiratory-24 Pathogen Detection Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202323-48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:37.206Z</lastUpdated>
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    <udiDi>08684387210188</udiDi>
    <basicUdiDi>B-08684387210188</basicUdiDi>
    <tradeName>RevoDx Respiratory-24 Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Respiratory-24 Pathogen Detection Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202323-24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:35.614Z</lastUpdated>
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    <udiDi>08684190150015</udiDi>
    <basicUdiDi>B-08684190150015</basicUdiDi>
    <tradeName>Respiratory Pathogens Detection and Monitoring Kit (24)</tradeName>
    <deviceName>Respiratory Pathogens Detection and Monitoring Kit (24)</deviceName>
    <manufacturerName>ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI</manufacturerName>
    <manufacturerSrn>TR-MF-000052831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010241</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:45:28.403Z</lastUpdated>
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    <udiDi>08683548256959</udiDi>
    <basicUdiDi>B-08683548256959</basicUdiDi>
    <tradeName>ChainFor Respiratory ID-4 Genotyping qPCR Kit</tradeName>
    <deviceName>Respiratory ID-4 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:49.508Z</lastUpdated>
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  <row>
    <udiDi>08594161958086</udiDi>
    <basicUdiDi>B-08594161958086</basicUdiDi>
    <tradeName>GeneProof Flu Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof Flu Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:19.365Z</lastUpdated>
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    <udiDi>08594161958062</udiDi>
    <basicUdiDi>B-08594161958062</basicUdiDi>
    <tradeName>GeneProof Flu Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof Flu Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:15.378Z</lastUpdated>
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    <udiDi>06976055490131</udiDi>
    <basicUdiDi>B-06976055490131</basicUdiDi>
    <tradeName>06976055490131</tradeName>
    <deviceName>Human Parainfluenza Virus and Adenovirus Nucleic Acid Detection Kit (Real-time Fluorescence PCR Method)</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:42.486Z</lastUpdated>
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    <udiDi>06976055490124</udiDi>
    <basicUdiDi>B-06976055490124</basicUdiDi>
    <tradeName>06976055490124</tradeName>
    <deviceName>Human Parainfluenza Virus and Adenovirus Nucleic Acid Detection Kit (Real-time Fluorescence PCR Method)</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:41.677Z</lastUpdated>
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  <row>
    <udiDi>06976055490094</udiDi>
    <basicUdiDi>B-06976055490094</basicUdiDi>
    <tradeName>06976055490094</tradeName>
    <deviceName>Influenza A/B Virus, SARS-CoV-2 and Respiratory Syncytial Virus Nucleic Acid Detection Kit (Real-time Fluorescence PCR Method)</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:36.080Z</lastUpdated>
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    <udiDi>06976055490087</udiDi>
    <basicUdiDi>B-06976055490087</basicUdiDi>
    <tradeName>06976055490087</tradeName>
    <deviceName>Influenza A/B Virus, SARS-CoV-2 and Respiratory Syncytial Virus Nucleic Acid Detection Kit (Real-time Fluorescence PCR Method)</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:35.286Z</lastUpdated>
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  <row>
    <udiDi>06975578360297</udiDi>
    <basicUdiDi>B-06975578360297</basicUdiDi>
    <tradeName>06975578360297</tradeName>
    <deviceName>PilotTM Multiple Respiratory Pathogens Digital PCR Kit</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000260</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:16.990Z</lastUpdated>
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  <row>
    <udiDi>06975578360211</udiDi>
    <basicUdiDi>B-06975578360211</basicUdiDi>
    <tradeName>06975578360211</tradeName>
    <deviceName>MTB/NTM Digital PCR Detection Kit</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000247</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:16.200Z</lastUpdated>
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  <row>
    <udiDi>06975447582225</udiDi>
    <basicUdiDi>B-06975447582225</basicUdiDi>
    <tradeName>06975447582225</tradeName>
    <deviceName>Encephalitis and Meningitis Syndrome 11-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve  Method)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0149-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:24.170Z</lastUpdated>
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  <row>
    <udiDi>06975447582218</udiDi>
    <basicUdiDi>B-06975447582218</basicUdiDi>
    <tradeName>06975447582218</tradeName>
    <deviceName>Respiratory Pathogens Detection Kit</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0100-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:23.347Z</lastUpdated>
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  <row>
    <udiDi>06975447582171</udiDi>
    <basicUdiDi>B-06975447582171</basicUdiDi>
    <tradeName>06975447582171</tradeName>
    <deviceName>Mycoplasma Pneumoniae / Adenovirus / Rhinovirus / Human Metapneumovirus Diagnostic Kit (PCR-Fluorescence)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0069-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:17.748Z</lastUpdated>
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    <udiDi>06975447582102</udiDi>
    <basicUdiDi>B-06975447582102</basicUdiDi>
    <tradeName>06975447582102</tradeName>
    <deviceName>Streptococcus Pneumoniae/ Klebsiella Pneumoniae/ Legionella Pneumophila/ Haemophilus influenzae/ Bordetella Pertussis Diagnostic Kit</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0055-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:08.939Z</lastUpdated>
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    <udiDi>06975447582072</udiDi>
    <basicUdiDi>B-06975447582072</basicUdiDi>
    <tradeName>06975447582072</tradeName>
    <deviceName>Influenza A Virus / Influenza B Virus/Respiratory Syncytial Virus Diagnostic Kit (PCR-Fluorescence)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0052-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:02.540Z</lastUpdated>
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    <udiDi>06975400320109</udiDi>
    <basicUdiDi>B-06975400320109</basicUdiDi>
    <tradeName>VIUICK</tradeName>
    <deviceName>Diagnostic Kit for Influenza virus/Respiratory syncytial virus/2019-nCoV RNA (Real-Time PCR Method)</deviceName>
    <manufacturerName>Guangzhou Viuick Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000017369</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:59.538Z</lastUpdated>
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    <udiDi>06975178390069</udiDi>
    <basicUdiDi>B-06975178390069</basicUdiDi>
    <tradeName>Multiply Respiratory Pathogen Virus Nucleic Acid Detection Kit</tradeName>
    <deviceName>Multiply Respiratory Pathogen Virus Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Nanjing RainGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023111</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>M006901</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:07:51.593Z</lastUpdated>
  </row>
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    <udiDi>06975178390021</udiDi>
    <basicUdiDi>B-06975178390021</basicUdiDi>
    <tradeName>FluA/FluB/RSV Virus Nucleic Acid Detection Kit</tradeName>
    <deviceName>FluA/FluB/RSV Virus Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Nanjing RainGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023111</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>F002101</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:07:50.800Z</lastUpdated>
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