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    <udiDi>08436566763219</udiDi>
    <basicUdiDi>B-08436566763219</basicUdiDi>
    <tradeName>Genesystems© Genebytes</tradeName>
    <deviceName>Genesystems© Genebytes</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4827</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:29.547Z</lastUpdated>
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  <row>
    <udiDi>08436566763202</udiDi>
    <basicUdiDi>B-08436566763202</basicUdiDi>
    <tradeName>Genesystems© – G-PRECON</tradeName>
    <deviceName>Genesystems© – G-PRECON</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4826</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:27.907Z</lastUpdated>
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    <udiDi>08436566763196</udiDi>
    <basicUdiDi>B-08436566763196</basicUdiDi>
    <tradeName>Genesystems G-NIPT</tradeName>
    <deviceName>Genesystems© G-NIPT</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:27.107Z</lastUpdated>
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    <udiDi>08436566763189</udiDi>
    <basicUdiDi>B-08436566763189</basicUdiDi>
    <tradeName>HubExome Focus Panel-GeneSGKit 48 reacciones</tradeName>
    <deviceName>HubExome Focus Panel-GeneSGKit 48 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4617</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:25.511Z</lastUpdated>
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  <row>
    <udiDi>08436566763172</udiDi>
    <basicUdiDi>B-08436566763172</basicUdiDi>
    <tradeName>HubExome Focus Panel-GeneSGKit 16 reacciones</tradeName>
    <deviceName>HubExome Focus Panel-GeneSGKit 16 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4616</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:22.303Z</lastUpdated>
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  <row>
    <udiDi>08436566763165</udiDi>
    <basicUdiDi>B-08436566763165</basicUdiDi>
    <tradeName>Agile-NIPT for MGI CE-IVD 48 Reacciones.</tradeName>
    <deviceName>Agile-NIPT for MGI CE-IVD 48 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4615</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:20.705Z</lastUpdated>
  </row>
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    <udiDi>08436566763158</udiDi>
    <basicUdiDi>B-08436566763158</basicUdiDi>
    <tradeName>hvNIPT-GeneSGKit CE-IVD 48 Reacciones</tradeName>
    <deviceName>hvNIPT-GeneSGKit CE-IVD 48 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4614</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:19.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566763141</udiDi>
    <basicUdiDi>B-08436566763141</basicUdiDi>
    <tradeName>HubExome Plus Panel-GeneSGKit 48 reacciones</tradeName>
    <deviceName>HubExome Plus Panel-GeneSGKit 48 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4613</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:18.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566763134</udiDi>
    <basicUdiDi>B-08436566763134</basicUdiDi>
    <tradeName>HubExome Plus Panel-GeneSGKit 16 reacciones</tradeName>
    <deviceName>HubExome Plus Panel-GeneSGKit 16 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4612</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:15.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566763127</udiDi>
    <basicUdiDi>B-08436566763127</basicUdiDi>
    <tradeName>MainTumorSolution-GeneSGKit 12 reacciones</tradeName>
    <deviceName>MainTumorSolution-GeneSGKit 12 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4582</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:14.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566763097</udiDi>
    <basicUdiDi>B-08436566763097</basicUdiDi>
    <tradeName>OncoClever-GeneSGKit 36 reacciones</tradeName>
    <deviceName>OncoClever-GeneSGKit 36 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4563</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:13.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566763004</udiDi>
    <basicUdiDi>B-08436566763004</basicUdiDi>
    <tradeName>MLD-GeneSGKit 12 reacciones</tradeName>
    <deviceName>MLD-GeneSGKit 12 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4485</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:11.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762823</udiDi>
    <basicUdiDi>B-08436566762823</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Fast CE-IVD Tubo 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Fast CE-IVD Tubo 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4454</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:09.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762816</udiDi>
    <basicUdiDi>B-08436566762816</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Fast-H CE-IVD Placa 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Fast-H CE-IVD Placa 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4453</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:08.242Z</lastUpdated>
  </row>
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    <udiDi>08436566762809</udiDi>
    <basicUdiDi>B-08436566762809</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4452</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:06.294Z</lastUpdated>
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    <udiDi>08436566762779</udiDi>
    <basicUdiDi>B-08436566762779</basicUdiDi>
    <tradeName>OncoFFPE-GeneSGKit Mamma 12 reacciones</tradeName>
    <deviceName>OncoFFPE-GeneSGKit Mamma 12 reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4440</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:04.691Z</lastUpdated>
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    <udiDi>08436566762762</udiDi>
    <basicUdiDi>B-08436566762762</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Lyo-L CE-IVD. Placa 96 Reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Lyo-L CE-IVD. Placa 96 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4429</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:02.309Z</lastUpdated>
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    <udiDi>08436566762755</udiDi>
    <basicUdiDi>B-08436566762755</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4427</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:00.691Z</lastUpdated>
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    <udiDi>08436566762748</udiDi>
    <basicUdiDi>B-08436566762748</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Lyo-H CE-IVD. Placa 96 Reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Lyo-H CE-IVD. Placa 96 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4428</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:59.885Z</lastUpdated>
  </row>
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    <udiDi>08436566762731</udiDi>
    <basicUdiDi>B-08436566762731</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR-L CE-IVD. Placa 96 Reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR-L CE-IVD. Placa 96 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4426</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:58.280Z</lastUpdated>
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