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    <basicUdiDi>B-84295779333Y7HJ</basicUdiDi>
    <tradeName>Simple Rotavirus / Stick Rotavirus</tradeName>
    <deviceName>Simple Rotavirus / Stick Rotavirus</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.333.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:18.833Z</lastUpdated>
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  <row>
    <udiDi>D-84295779242Y3GZ</udiDi>
    <basicUdiDi>B-84295779242Y3GZ</basicUdiDi>
    <tradeName>Simple Ag SARS-CoV-2 / Flu A+B</tradeName>
    <deviceName>Simple Ag SARS-CoV-2 / Flu A+B</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.242.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:17.686Z</lastUpdated>
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    <udiDi>D-84295779230XUJF</udiDi>
    <basicUdiDi>B-84295779230XUJF</basicUdiDi>
    <tradeName>Simple/Stick Campylobacter</tradeName>
    <deviceName>Simple/Stick Campylobacter</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.230.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:16.210Z</lastUpdated>
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    <udiDi>D-8429577923012CR23</udiDi>
    <basicUdiDi>B-8429577923012CR23</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.230.XXX.12.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:14.609Z</lastUpdated>
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  <row>
    <udiDi>D-84295779143XYK2</udiDi>
    <basicUdiDi>B-84295779143XYK2</basicUdiDi>
    <tradeName>SIMPLE ENTAMOEBA / STICK ENTAMOEBA</tradeName>
    <deviceName>SIMPLE ENTAMOEBA / STICK ENTAMOEBA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.143.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:12.201Z</lastUpdated>
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  <row>
    <udiDi>D-84295779108XWJT</udiDi>
    <basicUdiDi>B-84295779108XWJT</basicUdiDi>
    <tradeName>SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio</tradeName>
    <deviceName>SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.108.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:10.602Z</lastUpdated>
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  <row>
    <udiDi>D-8429577910837DH3R</udiDi>
    <basicUdiDi>B-8429577910837DH3R</basicUdiDi>
    <tradeName>CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.108.XXX.37.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:09.799Z</lastUpdated>
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  <row>
    <udiDi>D-84295779107XUJJ</udiDi>
    <basicUdiDi>B-84295779107XUJJ</basicUdiDi>
    <tradeName>SIMPLE Strep pneumo / STICK Strep pneumo</tradeName>
    <deviceName>SIMPLE Strep pneumo / STICK Strep pneumo</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.107.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:08.203Z</lastUpdated>
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  <row>
    <udiDi>D-84295779106XSJ9</udiDi>
    <basicUdiDi>B-84295779106XSJ9</basicUdiDi>
    <tradeName>SIMPLE Legio pneumo / STICK Legio pneumo</tradeName>
    <deviceName>SIMPLE Legio pneumo / STICK Legio pneumo</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.106.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:06.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779076YAJE</udiDi>
    <basicUdiDi>B-84295779076YAJE</basicUdiDi>
    <tradeName>Simple H.pyl / Stick H.pyl</tradeName>
    <deviceName>Simple H.pyl / Stick H.pyl</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.076.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:04.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779049Y7HN</udiDi>
    <basicUdiDi>B-84295779049Y7HN</basicUdiDi>
    <tradeName>Simple Calprotectina</tradeName>
    <deviceName>Simple Calprotectina</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.049.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:03.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8429577904912DP4G</udiDi>
    <basicUdiDi>B-8429577904912DP4G</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO CALPROTECTINA  || DRY CALPROTECTIN POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO CALPROTECTINA  - DRY CALPROTECTIN POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.049.XXX.12.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:01.794Z</lastUpdated>
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  <row>
    <udiDi>D-84295779038Y2GY</udiDi>
    <basicUdiDi>B-84295779038Y2GY</basicUdiDi>
    <tradeName>SIMPLE 2A-Bdiff / STICK 2A-Bdiff</tradeName>
    <deviceName>SIMPLE 2A-Bdiff / STICK 2A-Bdiff</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.038.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:59.397Z</lastUpdated>
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  <row>
    <udiDi>D-84295779028XXJY</udiDi>
    <basicUdiDi>B-84295779028XXJY</basicUdiDi>
    <tradeName>SIMPLE CD1WB</tradeName>
    <deviceName>SIMPLE CD1WB</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.028.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:57.791Z</lastUpdated>
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  <row>
    <udiDi>D-84295779041XPHT</udiDi>
    <basicUdiDi>B-84295779041XPHT</basicUdiDi>
    <tradeName>Simple Norovirus / Stick Norovirus</tradeName>
    <deviceName>Simple Norovirus / Stick Norovirus</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.041.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:56.995Z</lastUpdated>
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  <row>
    <udiDi>D-84295779029XZK9</udiDi>
    <basicUdiDi>B-84295779029XZK9</basicUdiDi>
    <tradeName>SIMPLE CD2WB</tradeName>
    <deviceName>SIMPLE CD2WB</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.029.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:55.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779023XMHH</udiDi>
    <basicUdiDi>B-84295779023XMHH</basicUdiDi>
    <tradeName>SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA</tradeName>
    <deviceName>SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.023.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:39.748Z</lastUpdated>
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  <row>
    <udiDi>D-84295779022XKH8</udiDi>
    <basicUdiDi>B-84295779022XKH8</basicUdiDi>
    <tradeName>SIMPLE CRYPTO / STICK CRYPTO</tradeName>
    <deviceName>SIMPLE CRYPTO / STICK CRYPTO</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.022.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:38.959Z</lastUpdated>
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  <row>
    <udiDi>D-84295779019XWJU</udiDi>
    <basicUdiDi>B-84295779019XWJU</basicUdiDi>
    <tradeName>SIMPLE GIARDIA / STICK GIARDIA</tradeName>
    <deviceName>SIMPLE GIARDIA / STICK GIARDIA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.019.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:38.861Z</lastUpdated>
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    <udiDi>D-84295779005XKH9</udiDi>
    <basicUdiDi>B-84295779005XKH9</basicUdiDi>
    <tradeName>Simple hCG s&amp;o / Stick hCG s&amp;o</tradeName>
    <deviceName>Simple hCG s&amp;o / Stick hCG s&amp;o</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.005.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:35.759Z</lastUpdated>
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