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<eudamedExport entity="devices">
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    <tradeName>FR166-Yellow Fever Virus -(Realtime PCR-Kit)</tradeName>
    <deviceName>FR166-Yellow Fever Virus -(Realtime PCR-Kit)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:56:14.435Z</lastUpdated>
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  <row>
    <udiDi>04050598009318</udiDi>
    <basicUdiDi>B-04050598009318</basicUdiDi>
    <tradeName>MutaPLEX BV-1 quant. (LAC/AV/GV)</tradeName>
    <deviceName>MutaPLEX BV-1 quant. (LAC/AV/GV)</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG197596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:14.889Z</lastUpdated>
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  <row>
    <udiDi>04050598009301</udiDi>
    <basicUdiDi>B-04050598009301</basicUdiDi>
    <tradeName>MutaPLEX STI-2 (TV/MH/UPU)</tradeName>
    <deviceName>MutaPLEX STI-2 (TV/MH/UPU)</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG197296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:14.095Z</lastUpdated>
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    <udiDi>04050598002791</udiDi>
    <basicUdiDi>B-04050598002791</basicUdiDi>
    <tradeName>MutaPLEX® Enterovirus, PCR</tradeName>
    <deviceName>MutaPLEX® Enterovirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:07.205Z</lastUpdated>
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  <row>
    <udiDi>04050598002784</udiDi>
    <basicUdiDi>B-04050598002784</basicUdiDi>
    <tradeName>MutaPLEX® Norovirus, PCR</tradeName>
    <deviceName>MutaPLEX® Norovirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040516</emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190132</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:05.577Z</lastUpdated>
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  <row>
    <udiDi>04050598002500</udiDi>
    <basicUdiDi>B-04050598002500</basicUdiDi>
    <tradeName>MutaPLEX® Norovirus, PCR</tradeName>
    <deviceName>MutaPLEX® Norovirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040516</emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:31.119Z</lastUpdated>
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  <row>
    <udiDi>04050598002418</udiDi>
    <basicUdiDi>B-04050598002418</basicUdiDi>
    <tradeName>MutaPLEX® Enterovirus, PCR</tradeName>
    <deviceName>MutaPLEX® Enterovirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:20.710Z</lastUpdated>
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  <row>
    <udiDi>04049095160448</udiDi>
    <basicUdiDi>B-04049095160448</basicUdiDi>
    <tradeName>04049095160448</tradeName>
    <deviceName>RIDA®GENE Enterovirus</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG4705</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:25.131Z</lastUpdated>
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  <row>
    <udiDi>03760367185037</udiDi>
    <basicUdiDi>B-03760367185037</basicUdiDi>
    <tradeName>IDTM SARS-CoV-2/Influenza Triplex</tradeName>
    <deviceName>IDRESPI-P1-100 (FR) - Boîtes</deviceName>
    <manufacturerName>ID SOLUTIONS</manufacturerName>
    <manufacturerSrn>FR-MF-000024876</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDRESPI-P1-100 (FR) - Boîtes</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:23.802Z</lastUpdated>
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  <row>
    <udiDi>00850027856094</udiDi>
    <basicUdiDi>B-00850027856094</basicUdiDi>
    <tradeName>Fluxergy Reaction Mix COVID-19</tradeName>
    <deviceName>Fluxergy Reaction Mix COVID-19</deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>4155-CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:42.333Z</lastUpdated>
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  <row>
    <udiDi>00840733101656</udiDi>
    <basicUdiDi>B-00840733101656</basicUdiDi>
    <tradeName>00840733101656</tradeName>
    <deviceName>Immunocard STAT Flu A&amp;B</deviceName>
    <manufacturerName>Princeton BioMeditech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000048310</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>782030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:41:16.757Z</lastUpdated>
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  <row>
    <udiDi>00840733101649</udiDi>
    <basicUdiDi>B-00840733101649</basicUdiDi>
    <tradeName>00840733101649</tradeName>
    <deviceName>Immunocard STAT Flu A&amp;B Nasopharyngeal Wash/Aspirate accessory kit</deviceName>
    <manufacturerName>Princeton BioMeditech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000048310</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>781130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:41:15.973Z</lastUpdated>
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  <row>
    <udiDi>D-00001280719907AT2</udiDi>
    <basicUdiDi>B-00001280719907AT2</basicUdiDi>
    <tradeName>Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:10.924Z</lastUpdated>
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  <row>
    <udiDi>D-0000128072010E1NV</udiDi>
    <basicUdiDi>B-0000128072010E1NV</basicUdiDi>
    <tradeName>Monkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Monkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:09.411Z</lastUpdated>
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    <udiDi>D-00001280716908AS4</udiDi>
    <basicUdiDi>B-00001280716908AS4</basicUdiDi>
    <tradeName>Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-EV026</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:13.235Z</lastUpdated>
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    <udiDi>+ENTIADVA00100I</udiDi>
    <basicUdiDi>B-+ENTIADVA00100I</basicUdiDi>
    <tradeName>+ENTIADVA00100I</tradeName>
    <deviceName>NovaLisa® Adenovirus IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADVA0010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:07:32.758Z</lastUpdated>
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    <udiDi>08809537078740</udiDi>
    <basicUdiDi>880953707RVP3116ZP</basicUdiDi>
    <tradeName>AccuPower® RV Kit (ExiStation™ FA 96)</tradeName>
    <deviceName>AccuPower® RV Kit (ExiStation™ FA 96)</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVP-3116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:13.865Z</lastUpdated>
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    <udiDi>08809537077866</udiDi>
    <basicUdiDi>880953707NCVM21111JH</basicUdiDi>
    <tradeName>AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit</tradeName>
    <deviceName>AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCVM2-1111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:51.407Z</lastUpdated>
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    <udiDi>08809537072533</udiDi>
    <basicUdiDi>880953707QRV1113YY</basicUdiDi>
    <tradeName>IRON-qPCR™ RV Kit</tradeName>
    <deviceName>IRON-qPCR™ RV Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QRV-1113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:50.614Z</lastUpdated>
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    <udiDi>08800174502933</udiDi>
    <basicUdiDi>88001745-DUO-R-6Z</basicUdiDi>
    <tradeName>08800174502933</tradeName>
    <deviceName>NX-Duo Genomic DNA Kit A</deviceName>
    <manufacturerName>Genolution Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000010391</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCF242</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:41.968Z</lastUpdated>
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