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<eudamedExport entity="devices">
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    <basicUdiDi>B-00854361008089</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:32.181Z</lastUpdated>
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    <udiDi>00854361008034</udiDi>
    <basicUdiDi>B-00854361008034</basicUdiDi>
    <tradeName>SureStep</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:31.360Z</lastUpdated>
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    <udiDi>00815845026036</udiDi>
    <basicUdiDi>B-00815845026036</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:01.586Z</lastUpdated>
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    <udiDi>00815845025732</udiDi>
    <basicUdiDi>B-00815845025732</basicUdiDi>
    <tradeName>SureStep</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:56.786Z</lastUpdated>
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    <udiDi>00815845026012</udiDi>
    <basicUdiDi>B-00815845026012</basicUdiDi>
    <tradeName>Innovacon</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:55.985Z</lastUpdated>
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  <row>
    <udiDi>00815845025985</udiDi>
    <basicUdiDi>B-00815845025985</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Ultra Pregnancy Test (Urine/Serum)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:55.197Z</lastUpdated>
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  <row>
    <udiDi>00815845025763</udiDi>
    <basicUdiDi>B-00815845025763</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine/Serum)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:54.509Z</lastUpdated>
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  <row>
    <udiDi>00815845025725</udiDi>
    <basicUdiDi>B-00815845025725</basicUdiDi>
    <tradeName>Innovacon</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:37.528Z</lastUpdated>
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  <row>
    <udiDi>00815845025718</udiDi>
    <basicUdiDi>B-00815845025718</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:36.731Z</lastUpdated>
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  <row>
    <udiDi>00815845025701</udiDi>
    <basicUdiDi>B-00815845025701</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:35.925Z</lastUpdated>
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  <row>
    <udiDi>00815845025695</udiDi>
    <basicUdiDi>B-00815845025695</basicUdiDi>
    <tradeName>InstAlert</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:35.128Z</lastUpdated>
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  <row>
    <udiDi>00815845025688</udiDi>
    <basicUdiDi>B-00815845025688</basicUdiDi>
    <tradeName>Innovacon</tradeName>
    <deviceName>hCG One Step Pregnancy Test (Urine)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:31.125Z</lastUpdated>
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  <row>
    <udiDi>00815845025664</udiDi>
    <basicUdiDi>B-00815845025664</basicUdiDi>
    <tradeName>Innovacon</tradeName>
    <deviceName>hCG One Step Ultra Pregnancy Test Urine/Serum)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:30.320Z</lastUpdated>
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  <row>
    <udiDi>00810124272807</udiDi>
    <basicUdiDi>B-00810124272807</basicUdiDi>
    <tradeName>00810124272807</tradeName>
    <deviceName>Strep A Rapid Test (Throat Swab)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:28.723Z</lastUpdated>
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  <row>
    <udiDi>00810124272784</udiDi>
    <basicUdiDi>B-00810124272784</basicUdiDi>
    <tradeName>00810124272784</tradeName>
    <deviceName>Strep A Rapid Test (Throat Swab)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:27.929Z</lastUpdated>
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    <udiDi>00810124272777</udiDi>
    <basicUdiDi>B-00810124272777</basicUdiDi>
    <tradeName>00810124272777</tradeName>
    <deviceName>Strep A Rapid Test (Throat Swab)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:23.919Z</lastUpdated>
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    <udiDi>00810124272760</udiDi>
    <basicUdiDi>B-00810124272760</basicUdiDi>
    <tradeName>00810124272760</tradeName>
    <deviceName>Strep A Rapid Test (Throat Swab)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:23.126Z</lastUpdated>
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    <udiDi>00810124272753</udiDi>
    <basicUdiDi>B-00810124272753</basicUdiDi>
    <tradeName>00810124272753</tradeName>
    <deviceName>Strep A Rapid Test (Throat Swab)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:22.322Z</lastUpdated>
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    <udiDi>00810124272746</udiDi>
    <basicUdiDi>B-00810124272746</basicUdiDi>
    <tradeName>00810124272746</tradeName>
    <deviceName>MONO Mononucleosis Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</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>IMO-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:21.525Z</lastUpdated>
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    <udiDi>00810124272739</udiDi>
    <basicUdiDi>B-00810124272739</basicUdiDi>
    <tradeName>00810124272739</tradeName>
    <deviceName>MONO Mononucleosis Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</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>IMO-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:14:17.517Z</lastUpdated>
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