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    <basicUdiDi>B-08012992503782</basicUdiDi>
    <tradeName>08012992503782</tradeName>
    <deviceName>IgA FITC/EVANS</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50378</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:17.049Z</lastUpdated>
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    <udiDi>08012992503737</udiDi>
    <basicUdiDi>B-08012992503737</basicUdiDi>
    <tradeName>08012992503737</tradeName>
    <deviceName>ASMA 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>50373</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:16.255Z</lastUpdated>
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    <udiDi>08012992503720</udiDi>
    <basicUdiDi>B-08012992503720</basicUdiDi>
    <tradeName>08012992503720</tradeName>
    <deviceName>AEA 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>44894</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:12.246Z</lastUpdated>
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    <udiDi>08012992503713</udiDi>
    <basicUdiDi>B-08012992503713</basicUdiDi>
    <tradeName>08012992503713</tradeName>
    <deviceName>AMA 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>50371</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:11.466Z</lastUpdated>
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    <udiDi>08012992503706</udiDi>
    <basicUdiDi>B-08012992503706</basicUdiDi>
    <tradeName>08012992503706</tradeName>
    <deviceName>NEGATIVE CONTROL</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50370</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:10.640Z</lastUpdated>
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    <udiDi>08012992503690</udiDi>
    <basicUdiDi>B-08012992503690</basicUdiDi>
    <tradeName>08012992503690</tradeName>
    <deviceName>ANA-Ho 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>50369</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:09.838Z</lastUpdated>
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    <udiDi>08012992503683</udiDi>
    <basicUdiDi>B-08012992503683</basicUdiDi>
    <tradeName>08012992503683</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>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50368</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:05.837Z</lastUpdated>
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    <udiDi>08012992503676</udiDi>
    <basicUdiDi>B-08012992503676</basicUdiDi>
    <tradeName>08012992503676</tradeName>
    <deviceName>nDNA 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50367</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:05.045Z</lastUpdated>
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    <udiDi>08012992503669</udiDi>
    <basicUdiDi>B-08012992503669</basicUdiDi>
    <tradeName>08012992503669</tradeName>
    <deviceName>P-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>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50366</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:04.242Z</lastUpdated>
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    <udiDi>08012992500651</udiDi>
    <basicUdiDi>B-08012992500651</basicUdiDi>
    <tradeName>08012992500651</tradeName>
    <deviceName>AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100799</emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50065</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:03.432Z</lastUpdated>
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    <udiDi>08012992500620</udiDi>
    <basicUdiDi>B-08012992500620</basicUdiDi>
    <tradeName>08012992500620</tradeName>
    <deviceName>AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100799</emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50062</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:59.434Z</lastUpdated>
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    <udiDi>08012992500613</udiDi>
    <basicUdiDi>B-08012992500613</basicUdiDi>
    <tradeName>08012992500613</tradeName>
    <deviceName>AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100799</emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50061</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:58.629Z</lastUpdated>
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    <udiDi>08012992500644</udiDi>
    <basicUdiDi>B-08012992500644</basicUdiDi>
    <tradeName>08012992500644</tradeName>
    <deviceName>ANTI-nDNA ANTIBODIES (nDNA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50064</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:57.832Z</lastUpdated>
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    <udiDi>08012992500637</udiDi>
    <basicUdiDi>B-08012992500637</basicUdiDi>
    <tradeName>08012992500637</tradeName>
    <deviceName>ANTI-nDNA ANTIBODIES (nDNA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:57.158Z</lastUpdated>
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    <udiDi>08012992500606</udiDi>
    <basicUdiDi>B-08012992500606</basicUdiDi>
    <tradeName>08012992500606</tradeName>
    <deviceName>ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50060</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:40.179Z</lastUpdated>
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    <udiDi>08012992500590</udiDi>
    <basicUdiDi>B-08012992500590</basicUdiDi>
    <tradeName>08012992500590</tradeName>
    <deviceName>ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50059</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:39.365Z</lastUpdated>
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    <udiDi>08012992500583</udiDi>
    <basicUdiDi>B-08012992500583</basicUdiDi>
    <tradeName>08012992500583</tradeName>
    <deviceName>ANTI-ENDOMYSIUM ANTIBODIES (AEA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50058</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:38.560Z</lastUpdated>
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    <udiDi>08012992500576</udiDi>
    <basicUdiDi>B-08012992500576</basicUdiDi>
    <tradeName>08012992500576</tradeName>
    <deviceName>ANTI-ENDOMYSIUM ANTIBODIES (AEA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50057</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:37.762Z</lastUpdated>
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    <udiDi>08012992500569</udiDi>
    <basicUdiDi>B-08012992500569</basicUdiDi>
    <tradeName>08012992500569</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>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50056</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:33.772Z</lastUpdated>
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    <udiDi>08012992500552</udiDi>
    <basicUdiDi>B-08012992500552</basicUdiDi>
    <tradeName>08012992500552</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>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100499</emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50055</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:32.961Z</lastUpdated>
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