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    <udiDi>06970895477109</udiDi>
    <basicUdiDi>B-06970895477109</basicUdiDi>
    <tradeName>06970895477109</tradeName>
    <deviceName>EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E011T048B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:07.835Z</lastUpdated>
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    <udiDi>06970895477093</udiDi>
    <basicUdiDi>B-06970895477093</basicUdiDi>
    <tradeName>06970895477093</tradeName>
    <deviceName>EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E011T024B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:06.628Z</lastUpdated>
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    <udiDi>06970895477086</udiDi>
    <basicUdiDi>B-06970895477086</basicUdiDi>
    <tradeName>06970895477086</tradeName>
    <deviceName>EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E011T016B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:05.448Z</lastUpdated>
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    <udiDi>06970895476096</udiDi>
    <basicUdiDi>B-06970895476096</basicUdiDi>
    <tradeName>06970895476096</tradeName>
    <deviceName>Influenza A and B virus nucleic acid test kit  (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R083T010B0C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:57:02.986Z</lastUpdated>
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    <udiDi>06970895476089</udiDi>
    <basicUdiDi>B-06970895476089</basicUdiDi>
    <tradeName>06970895476089</tradeName>
    <deviceName>Influenza A and B virus nucleic acid test kit  (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R083T050B0C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:56.992Z</lastUpdated>
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    <udiDi>06970895475709</udiDi>
    <basicUdiDi>B-06970895475709</basicUdiDi>
    <tradeName>06970895475709</tradeName>
    <deviceName>Zika virus, Dengue virus and Chikungunya virus Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040531</emdnCode>
    <emdnDescription>ZIKA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M10201T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:49.729Z</lastUpdated>
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    <udiDi>06970895475693</udiDi>
    <basicUdiDi>B-06970895475693</basicUdiDi>
    <tradeName>06970895475693</tradeName>
    <deviceName>Dengue Virus Genotyping Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M09601T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:48.523Z</lastUpdated>
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    <udiDi>06970895475532</udiDi>
    <basicUdiDi>B-06970895475532</basicUdiDi>
    <tradeName>06970895475532</tradeName>
    <deviceName>Dengue virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M09202T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:17.300Z</lastUpdated>
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  <row>
    <udiDi>06970877684037</udiDi>
    <basicUdiDi>B-06970877684037</basicUdiDi>
    <tradeName>Nucleic Acid Diagnostic Kit for SARS-CoV-2(Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0403</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:39.554Z</lastUpdated>
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    <udiDi>06970877684020</udiDi>
    <basicUdiDi>B-06970877684020</basicUdiDi>
    <tradeName>Nucleic Acid Diagnostic Kit for SARS-CoV-2(Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:38.348Z</lastUpdated>
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    <udiDi>06970877684013</udiDi>
    <basicUdiDi>B-06970877684013</basicUdiDi>
    <tradeName>Nucleic Acid Diagnostic Kit for SARS-CoV-2(Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:32.349Z</lastUpdated>
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  <row>
    <udiDi>06970514080949</udiDi>
    <basicUdiDi>B-06970514080949</basicUdiDi>
    <tradeName>06970514080949</tradeName>
    <deviceName>Monkeypox Virus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXVPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:24.075Z</lastUpdated>
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  <row>
    <udiDi>06970514080932</udiDi>
    <basicUdiDi>B-06970514080932</basicUdiDi>
    <tradeName>06970514080932</tradeName>
    <deviceName>Monkeypox Virus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXVPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:21.675Z</lastUpdated>
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    <udiDi>15420045509313</udiDi>
    <basicUdiDi>54200455DIAGPFFLUABRSVWG</basicUdiDi>
    <tradeName>Panther Fusion Flu A/B/RSV Assay Controls Kit</tradeName>
    <deviceName></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>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04336</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.335Z</lastUpdated>
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    <udiDi>06955792731844</udiDi>
    <basicUdiDi>B-06955792731844</basicUdiDi>
    <tradeName>06955792731844</tradeName>
    <deviceName>Respiratory Syncytial Virus RNA 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>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3048E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:17.805Z</lastUpdated>
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    <udiDi>06955792731837</udiDi>
    <basicUdiDi>B-06955792731837</basicUdiDi>
    <tradeName>06955792731837</tradeName>
    <deviceName>Respiratory Syncytial Virus RNA 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>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3048E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:16.615Z</lastUpdated>
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    <udiDi>06955792731721</udiDi>
    <basicUdiDi>B-06955792731721</basicUdiDi>
    <tradeName>Human Herpers Virus 6 DNA Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Human Herpers Virus 6 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3071E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:47.808Z</lastUpdated>
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    <udiDi>06955792731585</udiDi>
    <basicUdiDi>B-06955792731585</basicUdiDi>
    <tradeName>Dengue Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Dengue Virus RNA 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S3188E-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:24.979Z</lastUpdated>
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    <udiDi>06955792731516</udiDi>
    <basicUdiDi>B-06955792731516</basicUdiDi>
    <tradeName>06955792731516</tradeName>
    <deviceName>Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (Sequencing By Reversible Termination)</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>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C090-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:18.985Z</lastUpdated>
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    <udiDi>06955792731509</udiDi>
    <basicUdiDi>B-06955792731509</basicUdiDi>
    <tradeName>06955792731509</tradeName>
    <deviceName>Monkeypox virus 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3352E-24-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:17.781Z</lastUpdated>
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