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<eudamedExport entity="devices">
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    <udiDi>06936983104951</udiDi>
    <basicUdiDi>6970277510000KXX</basicUdiDi>
    <tradeName>MONO Rapid Test</tradeName>
    <deviceName>MONO Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMO-N402-25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:57:12.120Z</lastUpdated>
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  <row>
    <udiDi>D-IMO-402U8</udiDi>
    <basicUdiDi>B-IMO-402U8</basicUdiDi>
    <tradeName>D-IMO-402U8</tradeName>
    <deviceName>MONO Rapid Test Cassette (WB/S/P)</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMO-402</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:32.520Z</lastUpdated>
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  <row>
    <udiDi>D-IMO-R402HR</udiDi>
    <basicUdiDi>B-IMO-R402HR</basicUdiDi>
    <tradeName>MONO Rapid Test Cassette</tradeName>
    <deviceName>MONO Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMO-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:45.215Z</lastUpdated>
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    <udiDi>D-697994388Ir04038BX</udiDi>
    <basicUdiDi>B-697994388Ir04038BX</basicUdiDi>
    <tradeName>D-697994388Ir04038BX</tradeName>
    <deviceName>Norovirus GI/GII Antigen Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:24.277Z</lastUpdated>
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  <row>
    <udiDi>D-nvm-252003N-20UR</udiDi>
    <basicUdiDi>B-nvm-252003N-20UR</basicUdiDi>
    <tradeName>NADAL® Mononucleosis Test</tradeName>
    <deviceName>Mononucleosis Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>252003N-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:00.546Z</lastUpdated>
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  <row>
    <udiDi>D-VIMO-401RX</udiDi>
    <basicUdiDi>B-VIMO-401RX</basicUdiDi>
    <tradeName>Mononucleosis Rapid Test</tradeName>
    <deviceName>Mononucleosis Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIMO-401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:51.350Z</lastUpdated>
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  <row>
    <udiDi>D-GCMON-425aHG9Q</udiDi>
    <basicUdiDi>B-GCMON-425aHG9Q</basicUdiDi>
    <tradeName>Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-425a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:44.864Z</lastUpdated>
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  <row>
    <udiDi>D-GCMON-425a7C</udiDi>
    <basicUdiDi>B-GCMON-425a7C</basicUdiDi>
    <tradeName>Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-425a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:40.476Z</lastUpdated>
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  <row>
    <udiDi>D-GCMON-402aHG8D</udiDi>
    <basicUdiDi>B-GCMON-402aHG8D</basicUdiDi>
    <tradeName>Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:39.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMON-402a6R</udiDi>
    <basicUdiDi>B-GCMON-402a6R</basicUdiDi>
    <tradeName>Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-402a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:39.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMON-325aHG9B</udiDi>
    <basicUdiDi>B-GCMON-325aHG9B</basicUdiDi>
    <tradeName>Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma)</tradeName>
    <deviceName>Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-325a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:38.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMON-325a75</udiDi>
    <basicUdiDi>B-GCMON-325a75</basicUdiDi>
    <tradeName>Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-325a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:34.061Z</lastUpdated>
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  <row>
    <udiDi>16972698601320</udiDi>
    <basicUdiDi>B-16972698601320</basicUdiDi>
    <tradeName>EBNA IgG Rapid Test</tradeName>
    <deviceName>EBNA IgG Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231117</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:13.134Z</lastUpdated>
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  <row>
    <udiDi>16972698601313</udiDi>
    <basicUdiDi>B-16972698601313</basicUdiDi>
    <tradeName>EBV-VCA IgG Rapid Test</tradeName>
    <deviceName>EBV-VCA IgG Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231116</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:12.361Z</lastUpdated>
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    <udiDi>08053172971533</udiDi>
    <basicUdiDi>B-08053172971533</basicUdiDi>
    <tradeName>Mononucleosi Infettiva</tradeName>
    <deviceName>Mononucleosi Infettiva/ Infectious Mononucleosis</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7746</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:46:38.153Z</lastUpdated>
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    <udiDi>06976202763217</udiDi>
    <basicUdiDi>B-06976202763217</basicUdiDi>
    <tradeName>MONO Rapid Test</tradeName>
    <deviceName>MONO Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMONO-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:22.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762524</udiDi>
    <basicUdiDi>B-06976202762524</basicUdiDi>
    <tradeName>Mononucleosis Test</tradeName>
    <deviceName>Mononucleosis Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIMONO-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:19.964Z</lastUpdated>
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    <udiDi>06936983126212</udiDi>
    <basicUdiDi>B-06936983126212</basicUdiDi>
    <tradeName>Prueba Rápida de Mononucleosis en Casete</tradeName>
    <deviceName>Prueba Rápida de Mononucleosis en Casete</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMO-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:20:03.622Z</lastUpdated>
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    <udiDi>08426950001676</udiDi>
    <basicUdiDi>84269500016764Y</basicUdiDi>
    <tradeName>monogen kit 50 tests</tradeName>
    <deviceName>Monogen</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:40.142Z</lastUpdated>
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    <udiDi>05902643958579</udiDi>
    <basicUdiDi>59026439BRT345JS</basicUdiDi>
    <tradeName>05902643958579</tradeName>
    <deviceName>Mononucleosis 25 tests</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-345-K025</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:27:32.054Z</lastUpdated>
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