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<eudamedExport entity="devices">
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    <basicUdiDi>692591270078HN</basicUdiDi>
    <tradeName>iFlash-Unconjugated Estriol</tradeName>
    <deviceName>iFlash-Unconjugated Estriol</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:03.486Z</lastUpdated>
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    <udiDi>04260157631847</udiDi>
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    <tradeName>B·R·A·H·M·S uE3 KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S uE3 KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:48.854Z</lastUpdated>
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    <udiDi>15099590219765</udiDi>
    <basicUdiDi>150995905IM35946Q</basicUdiDi>
    <tradeName>RIA Unconjugated Estriol</tradeName>
    <deviceName>RIA Unconjugated Estriol</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3594</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:33.695Z</lastUpdated>
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    <udiDi>15099590231187</udiDi>
    <basicUdiDi>150995901AccuE3SE</basicUdiDi>
    <tradeName>Access Unconjugated Estriol (Reagent Pack)</tradeName>
    <deviceName>Access Unconjugated Estriol (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33570</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:34:39.693Z</lastUpdated>
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    <udiDi>D-6-100EY</udiDi>
    <basicUdiDi>B-6-100EY</basicUdiDi>
    <tradeName>D-6-100EY</tradeName>
    <deviceName>Unconjugated Estriol (uE3) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000101M, USIA00000102M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:26.739Z</lastUpdated>
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    <udiDi>06970150908997</udiDi>
    <basicUdiDi>B-06970150908997</basicUdiDi>
    <tradeName>uE3 CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMN0402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:58:11.653Z</lastUpdated>
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    <udiDi>06942359505871</udiDi>
    <basicUdiDi>B-06942359505871</basicUdiDi>
    <tradeName>uE3 CLIA Microparticals</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMN0401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:52:55.974Z</lastUpdated>
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    <udiDi>00630414971698</udiDi>
    <basicUdiDi>0405686901473VR</basicUdiDi>
    <tradeName>IMMULITE 2000 Unconjugated Estriol</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:57.584Z</lastUpdated>
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    <udiDi>D-IM4407099KE</udiDi>
    <basicUdiDi>B-IM4407099KE</basicUdiDi>
    <tradeName>D-IM4407099KE</tradeName>
    <deviceName>Unconjugated Estriol Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407099</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:11.876Z</lastUpdated>
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    <udiDi>D-IM4406099K7</udiDi>
    <basicUdiDi>B-IM4406099K7</basicUdiDi>
    <tradeName>D-IM4406099K7</tradeName>
    <deviceName>Unconjugated Estriol Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406099</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:08.283Z</lastUpdated>
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    <udiDi>D-IM4403099JJ</udiDi>
    <basicUdiDi>B-IM4403099JJ</basicUdiDi>
    <tradeName>D-IM4403099JJ</tradeName>
    <deviceName>Unconjugated Estriol Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403099</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:45.294Z</lastUpdated>
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    <udiDi>D-IM4402099JB</udiDi>
    <basicUdiDi>B-IM4402099JB</basicUdiDi>
    <tradeName>D-IM4402099JB</tradeName>
    <deviceName>Unconjugated Estriol Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402099</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:31.649Z</lastUpdated>
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  <row>
    <udiDi>D-AL-1382U</udiDi>
    <basicUdiDi>B-AL-1382U</basicUdiDi>
    <tradeName>AL-138-I - Estriol EIA (CE)</tradeName>
    <deviceName>AL-138-I - Estriol EIA (CE)</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-138</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:25.813Z</lastUpdated>
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    <udiDi>06925912723684</udiDi>
    <basicUdiDi>692591270078HN</basicUdiDi>
    <tradeName>iFlash-Unconjugated Estriol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86043-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.762Z</lastUpdated>
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    <udiDi>00630414997162</udiDi>
    <basicUdiDi>0405686901473VR</basicUdiDi>
    <tradeName>IMMULITE 2000 Unconjugated Estriol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381192</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:44:59.265Z</lastUpdated>
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    <udiDi>06975070762964</udiDi>
    <basicUdiDi>B-06975070762964</basicUdiDi>
    <tradeName>Sharay uE3 (CLIA)</tradeName>
    <deviceName>Sharay uE3 (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18715001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:03.645Z</lastUpdated>
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    <udiDi>06974969982629</udiDi>
    <basicUdiDi>B-06974969982629</basicUdiDi>
    <tradeName>Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1122-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:16:33.576Z</lastUpdated>
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    <udiDi>06974969982056</udiDi>
    <basicUdiDi>B-06974969982056</basicUdiDi>
    <tradeName>Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1122-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:13:06.248Z</lastUpdated>
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    <udiDi>06974969981486</udiDi>
    <basicUdiDi>B-06974969981486</basicUdiDi>
    <tradeName>Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1122-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:11:10.181Z</lastUpdated>
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    <udiDi>06974674892886</udiDi>
    <basicUdiDi>B-06974674892886</basicUdiDi>
    <tradeName>Free estriol(FE3) Detection Kit(CLIA)</tradeName>
    <deviceName>Free estriol(FE3) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0160</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:17:25.478Z</lastUpdated>
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