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<eudamedExport entity="devices">
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    <udiDi>D-084360385665660HK</udiDi>
    <basicUdiDi>B-084360385665660HK</basicUdiDi>
    <tradeName>Waaler Rose, 100 tests</tradeName>
    <deviceName>Waaler Rose, 100 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0219</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:27.840Z</lastUpdated>
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  <row>
    <udiDi>D-084360385655653HB</udiDi>
    <basicUdiDi>B-084360385655653HB</basicUdiDi>
    <tradeName>Rheumatoid factor (RF), 5 mL Latex, 1 mL Positive control, 1 mL Negative Control</tradeName>
    <deviceName>Rheumatoid factor (RF), 5 mL Latex, 1 mL Positive control, 1 mL Negative Control</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0218</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:26.242Z</lastUpdated>
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  <row>
    <udiDi>D-084360385645646H3</udiDi>
    <basicUdiDi>B-084360385645646H3</basicUdiDi>
    <tradeName>C-reactive protein (CRP), 5 mL Latex, 1 mL positive Control, 1 mL negative control</tradeName>
    <deviceName>C-reactive protein (CRP), 5 mL Latex, 1 mL positive Control, 1 mL negative control</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0217</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:25.441Z</lastUpdated>
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    <udiDi>D-084360385635639GT</udiDi>
    <basicUdiDi>B-084360385635639GT</basicUdiDi>
    <tradeName>Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative control</tradeName>
    <deviceName>Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative control</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0216</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:23.840Z</lastUpdated>
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  <row>
    <udiDi>D-084360385585588JD</udiDi>
    <basicUdiDi>B-084360385585588JD</basicUdiDi>
    <tradeName>CK-NAC, 4 x 50 mL</tradeName>
    <deviceName>CK-NAC, 4 x 50 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0209</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:21.443Z</lastUpdated>
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  <row>
    <udiDi>D-084360385535533FV</udiDi>
    <basicUdiDi>B-084360385535533FV</basicUdiDi>
    <tradeName>RF Latex, 1 x 5 mL</tradeName>
    <deviceName>RF Latex, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0191</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:19.851Z</lastUpdated>
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  <row>
    <udiDi>D-084360385525526FM</udiDi>
    <basicUdiDi>B-084360385525526FM</basicUdiDi>
    <tradeName>ASO Latex, 1 x 5 mL</tradeName>
    <deviceName>ASO Latex, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0190</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:19.036Z</lastUpdated>
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  <row>
    <udiDi>D-084360385515519FD</udiDi>
    <basicUdiDi>B-084360385515519FD</basicUdiDi>
    <tradeName>CRP Latex, 100 tests</tradeName>
    <deviceName>CRP Latex, 100 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0189</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:17.436Z</lastUpdated>
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  <row>
    <udiDi>D-084360385505502EH</udiDi>
    <basicUdiDi>B-084360385505502EH</basicUdiDi>
    <tradeName>TPHA, 200 tests</tradeName>
    <deviceName>TPHA, 200 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0177</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:15.050Z</lastUpdated>
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  <row>
    <udiDi>D-084360385495499JB</udiDi>
    <basicUdiDi>B-084360385495499JB</basicUdiDi>
    <tradeName>LDH, 20 x 3 mL</tradeName>
    <deviceName>LDH, 20 x 3 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010120</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE P ( LDH - P --&gt; L )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0166</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:13.434Z</lastUpdated>
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  <row>
    <udiDi>D-084360385485482HF</udiDi>
    <basicUdiDi>B-084360385485482HF</basicUdiDi>
    <tradeName>Gamma-GT, 20 x 2 mL</tradeName>
    <deviceName>GAMMA-GT, 20 x 2 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0160</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:12.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385415413EF</udiDi>
    <basicUdiDi>B-084360385415413EF</basicUdiDi>
    <tradeName>Polyvalent negative control, 1 x 1 mL</tradeName>
    <deviceName>Polyvalent negative control, 1 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0107</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:11.032Z</lastUpdated>
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  <row>
    <udiDi>D-084360385405406E7</udiDi>
    <basicUdiDi>B-084360385405406E7</basicUdiDi>
    <tradeName>Polyvalent positive control, 1 x 1 mL</tradeName>
    <deviceName>Polyvalent positive control, 1 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:08.634Z</lastUpdated>
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  <row>
    <udiDi>D-084360385395393HD</udiDi>
    <basicUdiDi>B-084360385395393HD</basicUdiDi>
    <tradeName>Albumin, 4 x 250 mL</tradeName>
    <deviceName>Albumin, 4 x 250 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0093</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:07.037Z</lastUpdated>
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  <row>
    <udiDi>D-084360385385386H5</udiDi>
    <basicUdiDi>B-084360385385386H5</basicUdiDi>
    <tradeName>Contro-P, 20 x 5 mL</tradeName>
    <deviceName>Contro-P, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0084</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:06.229Z</lastUpdated>
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  <row>
    <udiDi>D-084360385375379GV</udiDi>
    <basicUdiDi>B-084360385375379GV</basicUdiDi>
    <tradeName>Contro-N, 20 x 5 mL</tradeName>
    <deviceName>Contro-N, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0083</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:04.625Z</lastUpdated>
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  <row>
    <udiDi>D-084360385345348FH</udiDi>
    <basicUdiDi>B-084360385345348FH</basicUdiDi>
    <tradeName>Proteus OXK, 20 x 5 mL</tradeName>
    <deviceName>Proteus OXK, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0072</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:02.240Z</lastUpdated>
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  <row>
    <udiDi>D-084360385335331EM</udiDi>
    <basicUdiDi>B-084360385335331EM</basicUdiDi>
    <tradeName>Proteus OX2, 20 x 5 mL</tradeName>
    <deviceName>Proteus OX2, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0071</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:00.632Z</lastUpdated>
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  <row>
    <udiDi>D-084360385325324ED</udiDi>
    <basicUdiDi>B-084360385325324ED</basicUdiDi>
    <tradeName>Proteus OX19, 20 x 5 mL</tradeName>
    <deviceName>Proteus OX19, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:28:59.835Z</lastUpdated>
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  <row>
    <udiDi>D-084360385315317E5</udiDi>
    <basicUdiDi>B-084360385315317E5</basicUdiDi>
    <tradeName>Salmonella Paratyphi CO, 20 x 5 mL</tradeName>
    <deviceName>Salmonella Paratyphi CO, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011002</emdnCode>
    <emdnDescription>SALMONELLA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0069</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:28:58.225Z</lastUpdated>
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