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    <tradeName>06973642381278</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:29.426Z</lastUpdated>
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    <udiDi>06973642381261</udiDi>
    <basicUdiDi>B-06973642381261</basicUdiDi>
    <tradeName>06973642381261</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:25.437Z</lastUpdated>
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    <udiDi>06973642381254</udiDi>
    <basicUdiDi>B-06973642381254</basicUdiDi>
    <tradeName>06973642381254</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:24.624Z</lastUpdated>
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    <udiDi>06973642381247</udiDi>
    <basicUdiDi>B-06973642381247</basicUdiDi>
    <tradeName>06973642381247</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:23.825Z</lastUpdated>
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    <udiDi>06973642381230</udiDi>
    <basicUdiDi>B-06973642381230</basicUdiDi>
    <tradeName>06973642381230</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:23.024Z</lastUpdated>
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    <udiDi>06973642381223</udiDi>
    <basicUdiDi>B-06973642381223</basicUdiDi>
    <tradeName>06973642381223</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:19.021Z</lastUpdated>
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    <udiDi>06973642381216</udiDi>
    <basicUdiDi>B-06973642381216</basicUdiDi>
    <tradeName>06973642381216</tradeName>
    <deviceName>Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:23:18.235Z</lastUpdated>
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    <udiDi>06973316742732</udiDi>
    <basicUdiDi>B-06973316742732</basicUdiDi>
    <tradeName>06973316742732</tradeName>
    <deviceName>Freeze-Dried Multiplex Real Time PCR Kit for SARS-CoV-2/Influenza A/Influenza B</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R111053</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:07:01.401Z</lastUpdated>
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    <udiDi>06973316742725</udiDi>
    <basicUdiDi>B-06973316742725</basicUdiDi>
    <tradeName>06973316742725</tradeName>
    <deviceName>Freeze-Dried Multiplex Real Time PCR Kit for SARS-CoV-2/Influenza A/Influenza B</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R111052</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:07:00.584Z</lastUpdated>
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    <udiDi>06973316742718</udiDi>
    <basicUdiDi>B-06973316742718</basicUdiDi>
    <tradeName>06973316742718</tradeName>
    <deviceName>Freeze-Dried Multiplex Real Time PCR Kit for SARS-CoV-2/Influenza A/Influenza B</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R111051</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:56.582Z</lastUpdated>
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    <udiDi>06973315739238</udiDi>
    <basicUdiDi>B-06973315739238</basicUdiDi>
    <tradeName>Logilet Respiratory/Sore Throat (R/ST) Test Panel</tradeName>
    <deviceName>Logilet Respiratory/Sore Throat (R/ST) Test Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</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>DUR01M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:02:55.033Z</lastUpdated>
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    <udiDi>06971042225048</udiDi>
    <basicUdiDi>B-06971042225048</basicUdiDi>
    <tradeName>20 RP Panel I</tradeName>
    <deviceName>20 RP Panel I</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-0027-02P-12A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:38.908Z</lastUpdated>
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    <udiDi>06971042225031</udiDi>
    <basicUdiDi>B-06971042225031</basicUdiDi>
    <tradeName>14 RP Panel I</tradeName>
    <deviceName>14 RP Panel I</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0536-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:38.539Z</lastUpdated>
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    <udiDi>04050598010154</udiDi>
    <basicUdiDi>B-04050598010154</basicUdiDi>
    <tradeName>MutaPLEX® RespiraScreen 4 DIFF seqc., PCR</tradeName>
    <deviceName>MutaPLEX® RespiraScreen 4 DIFF seqc., PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1937-768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:54.199Z</lastUpdated>
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    <udiDi>04050598010147</udiDi>
    <basicUdiDi>B-04050598010147</basicUdiDi>
    <tradeName>MutaPLEX® RespiraScreen 4 DIFF seqc., PCR</tradeName>
    <deviceName>MutaPLEX® RespiraScreen 4 DIFF seqc., PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1937-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:50.200Z</lastUpdated>
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    <udiDi>04050598009325</udiDi>
    <basicUdiDi>B-04050598009325</basicUdiDi>
    <tradeName>MutaPLEX® RespiraScreen 4 DIFF seqc., PCR</tradeName>
    <deviceName>MutaPLEX® RespiraScreen 4 DIFF seqc., PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG193796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:18.894Z</lastUpdated>
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    <udiDi>04050598008014</udiDi>
    <basicUdiDi>B-04050598008014</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 2 DIFF, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 2 DIFF, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1928-768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:51.575Z</lastUpdated>
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    <udiDi>04050598008007</udiDi>
    <basicUdiDi>B-04050598008007</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 2 DIFF, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 2 DIFF, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1928-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:47.573Z</lastUpdated>
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    <udiDi>04050598007994</udiDi>
    <basicUdiDi>B-04050598007994</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 2 DIFF, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 2 DIFF, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</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>KG192896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:46.769Z</lastUpdated>
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    <udiDi>04050598006249</udiDi>
    <basicUdiDi>B-04050598006249</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 1, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</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>KG1927-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:24.363Z</lastUpdated>
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