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    <udiDi>08435440221708</udiDi>
    <basicUdiDi>84354402_MDXRESPB_RHE6D</basicUdiDi>
    <tradeName>VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-RHE113HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:54:04.131Z</lastUpdated>
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  <row>
    <udiDi>08435440221661</udiDi>
    <basicUdiDi>84354402_MDXRESPB_RHE6D</basicUdiDi>
    <tradeName>VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-RHE196TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:54:03.638Z</lastUpdated>
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    <udiDi>08435440223313</udiDi>
    <basicUdiDi>84354402_MDXRESPB_RHE6D</basicUdiDi>
    <tradeName>VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-RHE101E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:53:55.938Z</lastUpdated>
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    <udiDi>08435440221678</udiDi>
    <basicUdiDi>84354402_MDXRESPB_RHE6D</basicUdiDi>
    <tradeName>VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-RHE136E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:53:54.956Z</lastUpdated>
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    <udiDi>08435440221685</udiDi>
    <basicUdiDi>84354402_MDXRESPB_RHE6D</basicUdiDi>
    <tradeName>VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-RHE172E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:53:53.931Z</lastUpdated>
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  <row>
    <udiDi>D-IRAC-R62578</udiDi>
    <basicUdiDi>B-IRAC-R62578</basicUdiDi>
    <tradeName>Rotavirus and Adenovirus Combo Rapid Test Cassette</tradeName>
    <deviceName>Rotavirus and Adenovirus Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRAC-R625</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:12.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRAC-627EV</udiDi>
    <basicUdiDi>B-IRAC-627EV</basicUdiDi>
    <tradeName>Rotavirus and Adenovirus Combo Rapid Test</tradeName>
    <deviceName>Rotavirus and Adenovirus Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRAC-627</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:10.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMVD-647MA</udiDi>
    <basicUdiDi>B-IMVD-647MA</basicUdiDi>
    <tradeName>Norovirus,Rotavirus,Adenovirus,Astrovirus Combo Rapid Test</tradeName>
    <deviceName>Norovirus,Rotavirus,Adenovirus,Astrovirus Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMVD-647</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:08.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INRA-R635D6</udiDi>
    <basicUdiDi>B-INRA-R635D6</basicUdiDi>
    <tradeName>Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette</tradeName>
    <deviceName>Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INRA-R635</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:06.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBS-P1-10Y4</udiDi>
    <basicUdiDi>B-GBS-P1-10Y4</basicUdiDi>
    <tradeName>GBS Test</tradeName>
    <deviceName>GBS Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBS-P1-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:29:21.426Z</lastUpdated>
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  <row>
    <udiDi>08435440258759</udiDi>
    <basicUdiDi>84354402MDXSEXUALC_BHHTGT</basicUdiDi>
    <tradeName>VIASURE HSV-1, HSV-2 &amp; Treponema pallidum Assay for BD MAX™ System</tradeName>
    <deviceName>VIASURE HSV-1, HSV-2 &amp; Treponema pallidum Assay for BD MAX™ System</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>444222</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:15:01.475Z</lastUpdated>
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    <udiDi>08435440242475</udiDi>
    <basicUdiDi>84354402MDXRESPD_BBR1GR</basicUdiDi>
    <tradeName>VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System</tradeName>
    <deviceName>VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>444221</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:14:43.014Z</lastUpdated>
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  <row>
    <udiDi>08684190150459</udiDi>
    <basicUdiDi>B-08684190150459</basicUdiDi>
    <tradeName>Tropical Fever Detection and Monitoring Kit (24)</tradeName>
    <deviceName>Tropical Fever 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4150241</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T00:57:39.531Z</lastUpdated>
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    <udiDi>D-GEFTH-T625aOGT8</udiDi>
    <basicUdiDi>B-GEFTH-T625aOGT8</basicUdiDi>
    <tradeName>FOB/Transferrin/H. pylori Combo Rapid Test Device (Feces)</tradeName>
    <deviceName>FOB/Transferrin/H. pylori Combo Rapid Test Device (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFTH-T625a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:41:02.482Z</lastUpdated>
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    <udiDi>D-GEFTH-T625aHGSK</udiDi>
    <basicUdiDi>B-GEFTH-T625aHGSK</basicUdiDi>
    <tradeName>FOB/Transferrin/H.pylori Combo Rapid Test Device (Feces)</tradeName>
    <deviceName>FOB/Transferrin/H.pylori Combo Rapid Test Device (Feces)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFTH-T625a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:41:01.794Z</lastUpdated>
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    <udiDi>06970725815347</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>Respiratory Antigen Multiple Test Kit</tradeName>
    <deviceName>Respiratory Antigen Multiple Test Kit</deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2134-CRF-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:38:33.830Z</lastUpdated>
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    <udiDi>06970725815354</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815354</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2134-CRF-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:15.061Z</lastUpdated>
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    <udiDi>06970725815361</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815361</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2134-CRF-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:15.030Z</lastUpdated>
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    <udiDi>06970725815378</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815378</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2134-CRF-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.992Z</lastUpdated>
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    <udiDi>06970725815385</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815385</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2134-CR-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.964Z</lastUpdated>
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