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    <deviceName>Bacillus Pertussis Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>P088H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:59:09.703Z</lastUpdated>
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    <tradeName>06974323012061</tradeName>
    <deviceName>Duplex Real-time PCR Detection Kit for Bordetella Pertussis</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2472-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:49:22.366Z</lastUpdated>
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    <udiDi>06974323012054</udiDi>
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    <tradeName>06974323012054</tradeName>
    <deviceName>Duplex Real-time PCR Detection Kit for Bordetella Pertussis</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2472-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:49:20.755Z</lastUpdated>
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    <udiDi>06971042227769</udiDi>
    <basicUdiDi>B-06971042227769</basicUdiDi>
    <tradeName>Bordetella Pertussis &amp; Bordetella Parapertussis Real Time PCR Kit</tradeName>
    <deviceName>Bordetella Pertussis &amp; Bordetella Parapertussis Real Time PCR Kit</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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-0266-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:59:59.503Z</lastUpdated>
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    <udiDi>06971042227653</udiDi>
    <basicUdiDi>B-06971042227653</basicUdiDi>
    <tradeName>Bordetella Pertussis Real Time PCR Kit</tradeName>
    <deviceName>Bordetella Pertussis Real Time PCR Kit</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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-0061-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:59:28.080Z</lastUpdated>
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    <udiDi>04050598008533</udiDi>
    <basicUdiDi>B-04050598008533</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>KG190996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:18.792Z</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>
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    <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>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>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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011607</emdnCode>
    <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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    <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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    <udiDi>06955792731929</udiDi>
    <basicUdiDi>B-06955792731929</basicUdiDi>
    <tradeName>Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3136E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:40.629Z</lastUpdated>
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    <udiDi>06955792731912</udiDi>
    <basicUdiDi>B-06955792731912</basicUdiDi>
    <tradeName>Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3136E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:39.429Z</lastUpdated>
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    <udiDi>06955792731622</udiDi>
    <basicUdiDi>B-06955792731622</basicUdiDi>
    <tradeName>06955792731622</tradeName>
    <deviceName>Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3055E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:28.589Z</lastUpdated>
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    <basicUdiDi>B-06955792731615</basicUdiDi>
    <tradeName>Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3055E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:27.375Z</lastUpdated>
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    <udiDi>03532678593692</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_SEC02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:40:32.930Z</lastUpdated>
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