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    <deviceName>IgG FITC/EVANS (M)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:40.335Z</lastUpdated>
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    <basicUdiDi>B-08012992560440</basicUdiDi>
    <tradeName>08012992560440</tradeName>
    <deviceName>ASA-bm POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
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    <lastUpdated>2026-07-07T08:46:39.525Z</lastUpdated>
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    <udiDi>08012992560433</udiDi>
    <basicUdiDi>B-08012992560433</basicUdiDi>
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    <deviceName>ASA-is POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-07T08:46:38.721Z</lastUpdated>
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    <deviceName>GLYCIN</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:34.726Z</lastUpdated>
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    <udiDi>08012992560419</udiDi>
    <basicUdiDi>B-08012992560419</basicUdiDi>
    <tradeName>08012992560419</tradeName>
    <deviceName>GBMA POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>56041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:33.918Z</lastUpdated>
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    <udiDi>08012992560402</udiDi>
    <basicUdiDi>B-08012992560402</basicUdiDi>
    <tradeName>08012992560402</tradeName>
    <deviceName>AICA POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:33.129Z</lastUpdated>
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    <udiDi>08012992559246</udiDi>
    <basicUdiDi>B-08012992559246</basicUdiDi>
    <tradeName>08012992559246</tradeName>
    <deviceName>IgG FITC/EVANS</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:32.417Z</lastUpdated>
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    <udiDi>08012992555699</udiDi>
    <basicUdiDi>B-08012992555699</basicUdiDi>
    <tradeName>08012992555699</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55569</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:27.531Z</lastUpdated>
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    <udiDi>08012992555682</udiDi>
    <basicUdiDi>B-08012992555682</basicUdiDi>
    <tradeName>08012992555682</tradeName>
    <deviceName>ANTI-ISLET CELL ANTIBODIES (AICA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55568</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:26.715Z</lastUpdated>
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    <udiDi>08012992555675</udiDi>
    <basicUdiDi>B-08012992555675</basicUdiDi>
    <tradeName>08012992555675</tradeName>
    <deviceName>GLOMERULAR BASEMENT MEMBRANE ANTIBODIES (GBMA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55567</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:25.915Z</lastUpdated>
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    <udiDi>08012992555668</udiDi>
    <basicUdiDi>B-08012992555668</basicUdiDi>
    <tradeName>08012992555668</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55566</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:25.111Z</lastUpdated>
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    <udiDi>08012992555651</udiDi>
    <basicUdiDi>B-08012992555651</basicUdiDi>
    <tradeName>08012992555651</tradeName>
    <deviceName>ANTI-SKIN ANTIBODIES (ASA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55565</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:21.125Z</lastUpdated>
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    <udiDi>08012992518663</udiDi>
    <basicUdiDi>B-08012992518663</basicUdiDi>
    <tradeName>08012992518663</tradeName>
    <deviceName>C-ANCA POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51866</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:20.322Z</lastUpdated>
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    <udiDi>08012992504529</udiDi>
    <basicUdiDi>B-08012992504529</basicUdiDi>
    <tradeName>08012992504529</tradeName>
    <deviceName>APCA POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50452</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:18.810Z</lastUpdated>
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    <udiDi>08012992503867</udiDi>
    <basicUdiDi>B-08012992503867</basicUdiDi>
    <tradeName>08012992503867</tradeName>
    <deviceName>LKM POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50386</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:13.935Z</lastUpdated>
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    <udiDi>08012992503850</udiDi>
    <basicUdiDi>B-08012992503850</basicUdiDi>
    <tradeName>08012992503850</tradeName>
    <deviceName>ANA-Ce POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:13.116Z</lastUpdated>
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    <udiDi>08012992503843</udiDi>
    <basicUdiDi>B-08012992503843</basicUdiDi>
    <tradeName>08012992503843</tradeName>
    <deviceName>ANA-Nu POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:12.318Z</lastUpdated>
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    <udiDi>08012992503836</udiDi>
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    <tradeName>08012992503836</tradeName>
    <deviceName>ANA-Sp POSITIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:11.520Z</lastUpdated>
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    <deviceName>IgG FITC/EVANS (M)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:18.643Z</lastUpdated>
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    <deviceName>IgG FITC/EVANS</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
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    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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