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<eudamedExport entity="devices">
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    <basicUdiDi>B-06970664751355</basicUdiDi>
    <tradeName>06970664751355</tradeName>
    <deviceName>COVID-19 IgM Antibody ELISA Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:39.726Z</lastUpdated>
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    <udiDi>06970664751348</udiDi>
    <basicUdiDi>B-06970664751348</basicUdiDi>
    <tradeName>06970664751348</tradeName>
    <deviceName>COVID-19 IgG Antibody ELISA Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:38.526Z</lastUpdated>
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    <udiDi>06970664751331</udiDi>
    <basicUdiDi>B-06970664751331</basicUdiDi>
    <tradeName>06970664751331</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:37.325Z</lastUpdated>
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    <udiDi>06970664751324</udiDi>
    <basicUdiDi>B-06970664751324</basicUdiDi>
    <tradeName>06970664751324</tradeName>
    <deviceName>COVID-19 IgG/IgM Antibody Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:36.135Z</lastUpdated>
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    <udiDi>06970664750921</udiDi>
    <basicUdiDi>B-06970664750921</basicUdiDi>
    <tradeName>06970664750921</tradeName>
    <deviceName>COVID-19 IgG/IgM Ab Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:30.123Z</lastUpdated>
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    <udiDi>06970664750396</udiDi>
    <basicUdiDi>B-06970664750396</basicUdiDi>
    <tradeName>06970664750396</tradeName>
    <deviceName>Multiple Real-Time PCR kit for Detection of SARS-CoV-2</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:28.949Z</lastUpdated>
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    <udiDi>06970581432375</udiDi>
    <basicUdiDi>B-06970581432375</basicUdiDi>
    <tradeName>Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)</tradeName>
    <deviceName>Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:57.174Z</lastUpdated>
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    <udiDi>06970581432368</udiDi>
    <basicUdiDi>B-06970581432368</basicUdiDi>
    <tradeName>Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B399</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:55.975Z</lastUpdated>
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  <row>
    <udiDi>06970581432337</udiDi>
    <basicUdiDi>B-06970581432337</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B374</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:46.361Z</lastUpdated>
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  <row>
    <udiDi>06970581432320</udiDi>
    <basicUdiDi>B-06970581432320</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Saliva)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B372</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:45.159Z</lastUpdated>
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  <row>
    <udiDi>06970581432313</udiDi>
    <basicUdiDi>B-06970581432313</basicUdiDi>
    <tradeName>Accu-Tell® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® SARS-CoV-2 Neutralizing Antibody Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:43.977Z</lastUpdated>
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    <udiDi>06970581432306</udiDi>
    <basicUdiDi>B-06970581432306</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® SARS-CoV-2 Neutralizing Antibody Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:42.772Z</lastUpdated>
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  <row>
    <udiDi>06970581432146</udiDi>
    <basicUdiDi>B-06970581432146</basicUdiDi>
    <tradeName>Accu-Tell® SARS-CoV-2+Flu A&amp;B Antigen Combo Cassette (Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® SARS-CoV-2+Flu A&amp;B Antigen Combo Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B370</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:00.736Z</lastUpdated>
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    <udiDi>06970581430494</udiDi>
    <basicUdiDi>B-06970581430494</basicUdiDi>
    <tradeName>Accu-Tell® Rotavirus Cassette (Feces)</tradeName>
    <deviceName>Accu-Tell® Rotavirus Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B63</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:23.256Z</lastUpdated>
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    <udiDi>06970581430203</udiDi>
    <basicUdiDi>B-06970581430203</basicUdiDi>
    <tradeName>Accu-Tell® Rotavirus/Adenovirus Combo Cassette(Feces)</tradeName>
    <deviceName>Accu-Tell® Rotavirus/Adenovirus Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B64</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:01.641Z</lastUpdated>
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    <udiDi>06970581430043</udiDi>
    <basicUdiDi>B-06970581430043</basicUdiDi>
    <tradeName>Accu-Tell® SARS-CoV-2 (Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® SARS-CoV-2 Ag Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B367</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:41:53.245Z</lastUpdated>
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    <udiDi>06970581430036</udiDi>
    <basicUdiDi>B-06970581430036</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 IgG/IgM Cassette (Whole Blood/ Serum/ Plasma)</tradeName>
    <deviceName>Accu-Tell® COVID-19 IgG/IgM Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B352</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:41:52.059Z</lastUpdated>
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    <udiDi>06970277518277</udiDi>
    <basicUdiDi>B-06970277518277</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICOV-802H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:39:17.997Z</lastUpdated>
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    <udiDi>06970277515719</udiDi>
    <basicUdiDi>B-06970277515719</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICOV-502</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:39:06.085Z</lastUpdated>
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    <udiDi>06970277513340</udiDi>
    <basicUdiDi>B-06970277513340</basicUdiDi>
    <tradeName>06970277513340</tradeName>
    <deviceName>Norovirus/Rotavirus/Adenovirus Combo 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INRA-635</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:38:21.562Z</lastUpdated>
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</eudamedExport>