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<eudamedExport entity="devices">
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    <basicUdiDi>B-04050598005570</basicUdiDi>
    <tradeName>MutaPLEX® Babesia, PCR</tradeName>
    <deviceName>MutaPLEX® Babesia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192496</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:08.972Z</lastUpdated>
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    <udiDi>04050598005563</udiDi>
    <basicUdiDi>B-04050598005563</basicUdiDi>
    <tradeName>MutaPLEX® Babesia, PCR</tradeName>
    <deviceName>MutaPLEX® Babesia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192432</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:07.393Z</lastUpdated>
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    <udiDi>04050598005556</udiDi>
    <basicUdiDi>B-04050598005556</basicUdiDi>
    <tradeName>MutaPLEX® Rickettsia, PCR</tradeName>
    <deviceName>MutaPLEX® Rickettsia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>RICKETTSIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:04.990Z</lastUpdated>
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    <udiDi>04050598005549</udiDi>
    <basicUdiDi>B-04050598005549</basicUdiDi>
    <tradeName>MutaPLEX® Rickettsia, PCR</tradeName>
    <deviceName>MutaPLEX® Rickettsia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011605</emdnCode>
    <emdnDescription>RICKETTSIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192396</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:03.384Z</lastUpdated>
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    <udiDi>04050598005532</udiDi>
    <basicUdiDi>B-04050598005532</basicUdiDi>
    <tradeName>MutaPLEX® Blastocystis, PCR</tradeName>
    <deviceName>MutaPLEX® Blastocystis, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG191896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:02.576Z</lastUpdated>
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    <udiDi>04050598003484</udiDi>
    <basicUdiDi>B-04050598003484</basicUdiDi>
    <tradeName>MutaPLEX® Bordetella pertussis/parapertussis, PCR</tradeName>
    <deviceName>MutaPLEX® Bordetella pertussis/parapertussis, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG190932</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:03.272Z</lastUpdated>
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    <udiDi>04049095160325</udiDi>
    <basicUdiDi>B-04049095160325</basicUdiDi>
    <tradeName>04049095160325</tradeName>
    <deviceName>RIDA®GENE Bordetella</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG2505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:19.523Z</lastUpdated>
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    <udiDi>04049055002917</udiDi>
    <basicUdiDi>B-04049055002917</basicUdiDi>
    <tradeName>micro-IDent®plus11 VER 1.0</tradeName>
    <deviceName>micro-IDent®plus11 VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23396</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:04:07.424Z</lastUpdated>
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    <udiDi>04049055000531</udiDi>
    <basicUdiDi>B-04049055000531</basicUdiDi>
    <tradeName>micro-IDent® VER 2.0</tradeName>
    <deviceName>micro-IDent® VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:47.507Z</lastUpdated>
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    <udiDi>D-000012807170093PR</udiDi>
    <basicUdiDi>B-000012807170093PR</basicUdiDi>
    <tradeName>Bacillus Anthracis Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Bacillus Anthracis 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT018</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:11.638Z</lastUpdated>
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    <udiDi>08906213930658</udiDi>
    <basicUdiDi>89080153043B249NR</basicUdiDi>
    <tradeName>TRUPCR® Leptospira Detection Kit</tradeName>
    <deviceName>TRUPCR® Leptospira Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B249/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:21.839Z</lastUpdated>
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    <udiDi>08429577003122</udiDi>
    <basicUdiDi>84295775182XE</basicUdiDi>
    <tradeName>Real Respiratory Bacterial Panel 2  (B. pertussis, B. parapertussis, B. holmesii)</tradeName>
    <deviceName>Real Respiratory Bacterial Panel 2  (B. pertussis, B. parapertussis, B. holmesii)</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.182.096.88.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:44.816Z</lastUpdated>
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    <udiDi>08429577003139</udiDi>
    <basicUdiDi>84295775182XE</basicUdiDi>
    <tradeName>Real Respiratory Bacterial Panel 2  (B. pertussis, B. parapertussis, B. holmesii)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.182.048.88.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:38:55.871Z</lastUpdated>
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    <udiDi>15420045512023</udiDi>
    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
    <deviceName>Aptima BV Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05186</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:23.772Z</lastUpdated>
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    <udiDi>03573026584078</udiDi>
    <basicUdiDi>357302BUDI000489U8</basicUdiDi>
    <tradeName>Lyophilized rabbit plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>540603</reference>
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    <lastUpdated>2026-07-02T00:35:37.089Z</lastUpdated>
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    <udiDi>04049095210174</udiDi>
    <basicUdiDi>4049095UN25050000R6</basicUdiDi>
    <tradeName>04049095210174</tradeName>
    <deviceName>RIDA®UNITY Bordetella</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN2505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:50.525Z</lastUpdated>
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    <udiDi>03532678593685</udiDi>
    <basicUdiDi>353267F00133P7Y</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Bordetella</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150068_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:23.465Z</lastUpdated>
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    <basicUdiDi>353267F00057P8F</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Leptospira</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150064</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:21.048Z</lastUpdated>
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    <udiDi>08435440258704</udiDi>
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    <tradeName>VIASURE</tradeName>
    <deviceName>VIASURE Mycoplasma genitalium with Macrolide Resistance 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>444224</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:31:29.070Z</lastUpdated>
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    <udiDi>06973492240176</udiDi>
    <basicUdiDi>697349224U2020092C000GU</basicUdiDi>
    <tradeName>EasyNAT BP Assay</tradeName>
    <deviceName>EasyNAT BP Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20209</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:29.226Z</lastUpdated>
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