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    <basicUdiDi>B-84295775237XEGW</basicUdiDi>
    <tradeName>Real SARS-CoV-2/Flu/RSV</tradeName>
    <deviceName>Real SARS-CoV-2/Flu/RSV</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.237.XXX.88.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:33.339Z</lastUpdated>
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    <udiDi>D-84295773165WYH9</udiDi>
    <basicUdiDi>B-84295773165WYH9</basicUdiDi>
    <tradeName>S. PneumoStrip</tradeName>
    <deviceName>S. PneumoStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.165.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:31.732Z</lastUpdated>
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    <udiDi>D-84295773154WTGK</udiDi>
    <basicUdiDi>B-84295773154WTGK</basicUdiDi>
    <tradeName>HLA B27 Strip</tradeName>
    <deviceName>HLA B27 Strip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.154.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:30.941Z</lastUpdated>
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    <udiDi>D-84295773152WPFZ</udiDi>
    <basicUdiDi>B-84295773152WPFZ</basicUdiDi>
    <tradeName>CeliacStrip</tradeName>
    <deviceName>CeliacStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.152.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:29.337Z</lastUpdated>
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    <udiDi>D-84295773151WMFN</udiDi>
    <basicUdiDi>B-84295773151WMFN</basicUdiDi>
    <tradeName>YChromStrip</tradeName>
    <deviceName>YChromStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.151.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:26.935Z</lastUpdated>
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    <udiDi>D-84295773150WKFD</udiDi>
    <basicUdiDi>B-84295773150WKFD</basicUdiDi>
    <tradeName>STD Panel Strip</tradeName>
    <deviceName>STD Panel Strip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.150.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:25.333Z</lastUpdated>
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    <udiDi>D-84295773148WYHA</udiDi>
    <basicUdiDi>B-84295773148WYHA</basicUdiDi>
    <tradeName>High + Low PapillomaStrip</tradeName>
    <deviceName>High + Low PapillomaStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.148.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:24.531Z</lastUpdated>
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    <udiDi>D-84295773146WUGQ</udiDi>
    <basicUdiDi>B-84295773146WUGQ</basicUdiDi>
    <tradeName>High PapillomaStrip</tradeName>
    <deviceName>High PapillomaStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.146.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:22.930Z</lastUpdated>
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    <udiDi>D-84295773135WPG2</udiDi>
    <basicUdiDi>B-84295773135WPG2</basicUdiDi>
    <tradeName>LactoStrip</tradeName>
    <deviceName>LactoStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010402</emdnCode>
    <emdnDescription>LACTOSE INTOLERANCE (POLYMORPHISMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.135.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:20.530Z</lastUpdated>
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  <row>
    <udiDi>D-84295773130WDEH</udiDi>
    <basicUdiDi>B-84295773130WDEH</basicUdiDi>
    <tradeName>HemochromaStrip</tradeName>
    <deviceName>HemochromaStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.130.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:18.926Z</lastUpdated>
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  <row>
    <udiDi>D-84295773117WMFQ</udiDi>
    <basicUdiDi>B-84295773117WMFQ</basicUdiDi>
    <tradeName>ThromboSrip</tradeName>
    <deviceName>ThromboStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.117.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:18.126Z</lastUpdated>
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  <row>
    <udiDi>D-84295773095X4FE</udiDi>
    <basicUdiDi>B-84295773095X4FE</basicUdiDi>
    <tradeName>Respiratory Bacterial Panel Strip</tradeName>
    <deviceName>Respiratory Bacterial Panel Strip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.095.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:16.529Z</lastUpdated>
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  <row>
    <udiDi>08429577001616</udiDi>
    <basicUdiDi>B-08429577001616</basicUdiDi>
    <tradeName>Simple PSA / Stick PSA</tradeName>
    <deviceName>Simple PSA / Stick PSA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.444.030.00.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:27:56.773Z</lastUpdated>
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  <row>
    <udiDi>08429577004808</udiDi>
    <basicUdiDi>8429577906512DH</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO GDH-TOXINS / DRY POSITIVE CONTROL GDH-TOXINS</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.065.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:18:02.428Z</lastUpdated>
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    <udiDi>08429577004679</udiDi>
    <basicUdiDi>84295779231XW</basicUdiDi>
    <tradeName>Simple H.pyl-Tf</tradeName>
    <deviceName>SIMPLE H.pyl-Tf</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.231.020.21.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:18:01.623Z</lastUpdated>
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  <row>
    <udiDi>08429577004143</udiDi>
    <basicUdiDi>84295779134XX</basicUdiDi>
    <tradeName>Simple / Stick Strep A</tradeName>
    <deviceName>Simple Strep A / Stick Strep A</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.134.040.00.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:57.620Z</lastUpdated>
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    <udiDi>08429577004112</udiDi>
    <basicUdiDi>8429577914420D8</basicUdiDi>
    <tradeName>Simple Crypto-Giardia-Entamoeba 4R</tradeName>
    <deviceName>Simple Crypto-Giardia-Entamoeba 4R</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.144.020.20.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:56.820Z</lastUpdated>
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    <udiDi>08429577004051</udiDi>
    <basicUdiDi>8429577923112CW</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO H.PYL-TF  ||  H.PYL-TF DRY POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO H.PYL-TF / H.PYL-TF DRY POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.231.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:56.252Z</lastUpdated>
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    <udiDi>08429577003948</udiDi>
    <basicUdiDi>8429577914412D9</basicUdiDi>
    <tradeName>Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control</tradeName>
    <deviceName>Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.144.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:55.232Z</lastUpdated>
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    <udiDi>08429577003481</udiDi>
    <basicUdiDi>8429577905012CH</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO ROTA-ADENO-NORO  || DRY POSITIVE CONTROL  ROTA-ADENO-NORO</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO ROTA-ADENO-NORO/DRY POSITIVE CONTROL ROTA-ADENO-NORO</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.050.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:51.231Z</lastUpdated>
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