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<eudamedExport entity="devices">
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    <tradeName>Z-GEM 5 Lyse 1A</tradeName>
    <deviceName>Z-GEM 5 Lyse 1A</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RL15P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:21.696Z</lastUpdated>
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    <udiDi>42625753904816</udiDi>
    <basicUdiDi>B-42625753904816</basicUdiDi>
    <tradeName>SHEATH</tradeName>
    <deviceName>SHEATH</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RS5RP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:20.906Z</lastUpdated>
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    <udiDi>42625753904670</udiDi>
    <basicUdiDi>B-42625753904670</basicUdiDi>
    <tradeName>LYSE SOLUTION</tradeName>
    <deviceName>LYSE SOLUTION</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RLG3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:16.100Z</lastUpdated>
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  <row>
    <udiDi>42625753904502</udiDi>
    <basicUdiDi>B-42625753904502</basicUdiDi>
    <tradeName>LYSE</tradeName>
    <deviceName>LYSE</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RL5RP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:15.295Z</lastUpdated>
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    <udiDi>42625753904434</udiDi>
    <basicUdiDi>B-42625753904434</basicUdiDi>
    <tradeName>Z-GEM 5 Lyse 3A</tradeName>
    <deviceName>Z-GEM 5 Lyse 3A</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RL35P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:14.494Z</lastUpdated>
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  <row>
    <udiDi>42625753904366</udiDi>
    <basicUdiDi>B-42625753904366</basicUdiDi>
    <tradeName>Z-GEM 5 Lyse 2</tradeName>
    <deviceName>Z-GEM 5 Lyse 2</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RL25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:10.494Z</lastUpdated>
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  <row>
    <udiDi>42625753904298</udiDi>
    <basicUdiDi>B-42625753904298</basicUdiDi>
    <tradeName>Z-GEM 5 Lyse 1</tradeName>
    <deviceName>Z-GEM 5 Lyse 1</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RL15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:09.691Z</lastUpdated>
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  <row>
    <udiDi>42625753904120</udiDi>
    <basicUdiDi>B-42625753904120</basicUdiDi>
    <tradeName>DILUENT</tradeName>
    <deviceName>DILUENT</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RDG3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:08.889Z</lastUpdated>
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  <row>
    <udiDi>42625753904052</udiDi>
    <basicUdiDi>B-42625753904052</basicUdiDi>
    <tradeName>DETERGENT</tradeName>
    <deviceName>DETERGENT</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RDE5RP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:08.088Z</lastUpdated>
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  <row>
    <udiDi>42625753903994</udiDi>
    <basicUdiDi>B-42625753903994</basicUdiDi>
    <tradeName>DILUENT</tradeName>
    <deviceName>DILUENT</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RD5RP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:04.084Z</lastUpdated>
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  <row>
    <udiDi>42625753903826</udiDi>
    <basicUdiDi>B-42625753903826</basicUdiDi>
    <tradeName>Z-GEM 5+ Diluent</tradeName>
    <deviceName>Z-GEM 5+ Diluent</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RD5P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:03.280Z</lastUpdated>
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  <row>
    <udiDi>42625753903758</udiDi>
    <basicUdiDi>B-42625753903758</basicUdiDi>
    <tradeName>Z-GEM 5 DILUENT</tradeName>
    <deviceName>Z-GEM 5 DILUENT</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RD5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:02.476Z</lastUpdated>
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  <row>
    <udiDi>42625753903512</udiDi>
    <basicUdiDi>B-42625753903512</basicUdiDi>
    <tradeName>PROBE CLEANER</tradeName>
    <deviceName>PROBE CLEANER</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RC5RP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:01.684Z</lastUpdated>
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  <row>
    <udiDi>42625753903444</udiDi>
    <basicUdiDi>B-42625753903444</basicUdiDi>
    <tradeName>Z-GEM CLEANSER</tradeName>
    <deviceName>Z-GEM CLEANSER</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:57.680Z</lastUpdated>
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  <row>
    <udiDi>15065026245233</udiDi>
    <basicUdiDi>B-15065026245233</basicUdiDi>
    <tradeName>TruCell</tradeName>
    <deviceName>CBC Kit</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC60002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:34.849Z</lastUpdated>
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  <row>
    <udiDi>00630414223032</udiDi>
    <basicUdiDi>0405686900798WH</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i® Sheath/Rinse</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10316869</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:51:00.439Z</lastUpdated>
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    <udiDi>05907514688791</udiDi>
    <basicUdiDi>590751468-866_8-886CR</basicUdiDi>
    <tradeName>DILUENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-879</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:27:39.466Z</lastUpdated>
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    <udiDi>05907514688821</udiDi>
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    <tradeName>DILUENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-882</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:27:39.443Z</lastUpdated>
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    <tradeName>DILUENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-886</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:27:39.400Z</lastUpdated>
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    <tradeName>LYSING REAGENT CN FREE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-890</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:27:39.376Z</lastUpdated>
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