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<eudamedExport entity="devices">
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    <udiDi>06974785750327</udiDi>
    <basicUdiDi>B-06974785750327</basicUdiDi>
    <tradeName>FOB (Human Occult Blood) Rapid Test (Feces)</tradeName>
    <deviceName>FOB (Human Occult Blood) Rapid Test (Feces)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFO-3013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:53.744Z</lastUpdated>
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    <udiDi>06971980730161</udiDi>
    <basicUdiDi>B-06971980730161</basicUdiDi>
    <tradeName>ColoClear</tradeName>
    <deviceName>Coloclear® Multi-parameter Detection Kit for Human KRAS Gene Mutation, BMP3/NDRG4 Gene Methylation, and FIT (Real time PCR -Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou New Horizon Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027517</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:33:30.843Z</lastUpdated>
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    <udiDi>06952804837082</udiDi>
    <basicUdiDi>B-06952804837082</basicUdiDi>
    <tradeName>06952804837082</tradeName>
    <deviceName>β2-microglobulin Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G217A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:48.706Z</lastUpdated>
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    <udiDi>06952804825997</udiDi>
    <basicUdiDi>B-06952804825997</basicUdiDi>
    <tradeName>06952804825997</tradeName>
    <deviceName>Carcinoembryonic Antigen Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G207A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:39.898Z</lastUpdated>
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    <udiDi>06952804825980</udiDi>
    <basicUdiDi>B-06952804825980</basicUdiDi>
    <tradeName>06952804825980</tradeName>
    <deviceName>Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G200A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:36.358Z</lastUpdated>
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  <row>
    <udiDi>03800502152088</udiDi>
    <basicUdiDi>B-03800502152088</basicUdiDi>
    <tradeName>Lepzi BTA Test</tradeName>
    <deviceName>Lepzi BTA Test</deviceName>
    <manufacturerName>Lepzi Diagnostika Ltd.</manufacturerName>
    <manufacturerSrn>BG-MF-000051504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160201</emdnCode>
    <emdnDescription>BTA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD_BG006</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:36:46.647Z</lastUpdated>
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    <udiDi>03700531700154</udiDi>
    <basicUdiDi>B-03700531700154</basicUdiDi>
    <tradeName>HEMOTRUST</tradeName>
    <deviceName>HEMOTRUST</deviceName>
    <manufacturerName>BIOSYNEX Swiss SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024717</manufacturerSrn>
    <authorisedRepresentativeName>BIOSYNEX</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000014076</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1110002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:24:18.415Z</lastUpdated>
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    <udiDi>00860000930949</udiDi>
    <basicUdiDi>B-00860000930949</basicUdiDi>
    <tradeName>Ora-3D</tradeName>
    <deviceName>Ora-3D</deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:53.225Z</lastUpdated>
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  <row>
    <udiDi>00628347564094</udiDi>
    <basicUdiDi>B-00628347564094</basicUdiDi>
    <tradeName>Artron Fecal Occult Blood (FOB)Test</tradeName>
    <deviceName>Fecal Occult Blood (FOB)Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A05-02-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:59.856Z</lastUpdated>
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    <udiDi>00083059108156</udiDi>
    <basicUdiDi>B-00083059108156</basicUdiDi>
    <tradeName>EZ-PSA Professional PSA Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1081-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:24.648Z</lastUpdated>
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  <row>
    <udiDi>00083059108118</udiDi>
    <basicUdiDi>B-00083059108118</basicUdiDi>
    <tradeName>Fortel® Prostate (PSA) Screening Test</tradeName>
    <deviceName>Fortel Prostate (PSA) Screening Test</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1081-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:23.857Z</lastUpdated>
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  <row>
    <udiDi>06970725810472</udiDi>
    <basicUdiDi>B-06970725810472</basicUdiDi>
    <tradeName>NOVAtest® Fecal Occult Blood Test</tradeName>
    <deviceName>Fecal Occult Blood Test</deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:47:40.741Z</lastUpdated>
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  <row>
    <udiDi>06970221769106</udiDi>
    <basicUdiDi>B-06970221769106</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName>FOB 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>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:36:02.820Z</lastUpdated>
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  <row>
    <udiDi>06956013941929</udiDi>
    <basicUdiDi>B-06956013941929</basicUdiDi>
    <tradeName>06956013941929</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031214</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>--</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:37.447Z</lastUpdated>
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    <udiDi>06956013940342</udiDi>
    <basicUdiDi>B-06956013940342</basicUdiDi>
    <tradeName>06956013940342</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031214</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>--</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:31.441Z</lastUpdated>
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    <udiDi>06956013940243</udiDi>
    <basicUdiDi>B-06956013940243</basicUdiDi>
    <tradeName>06956013940243</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031214</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:30.256Z</lastUpdated>
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    <udiDi>06952999408944</udiDi>
    <basicUdiDi>B-06952999408944</basicUdiDi>
    <tradeName>06952999408944</tradeName>
    <deviceName>FOB One Step Fecal Occult Blood Test Device (Feces)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFO-602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:14.339Z</lastUpdated>
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    <udiDi>06952999408937</udiDi>
    <basicUdiDi>B-06952999408937</basicUdiDi>
    <tradeName>06952999408937</tradeName>
    <deviceName>FOB One Step Fecal Occult Blood Test Device (Feces)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFO-602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:12.828Z</lastUpdated>
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    <udiDi>06952804827113</udiDi>
    <basicUdiDi>B-06952804827113</basicUdiDi>
    <tradeName>Faecal Occult Blood Rapid Test</tradeName>
    <deviceName>Faecal Occult Blood Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-F23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:42.856Z</lastUpdated>
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    <udiDi>06952804803278</udiDi>
    <basicUdiDi>B-06952804803278</basicUdiDi>
    <tradeName>FOB FIA</tradeName>
    <deviceName>FOB FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-F23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:40.669Z</lastUpdated>
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