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    <deviceName>TECO® Human Intact Proinsulin ELISA</deviceName>
    <manufacturerName>TECOmedical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000030341</manufacturerSrn>
    <authorisedRepresentativeName>EUROBIO SCIENTIFIC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000023178</authorisedRepresentativeSrn>
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    <emdnDescription>PROINSULIN</emdnDescription>
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    <lastUpdated>2026-07-07T02:58:09.355Z</lastUpdated>
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    <udiDi>07350108630153</udiDi>
    <basicUdiDi>B-07350108630153</basicUdiDi>
    <tradeName>Mercodia Proinsulin ELISA</tradeName>
    <deviceName>Mercodia Proinsulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
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    <udiDi>07350108630122</udiDi>
    <basicUdiDi>B-07350108630122</basicUdiDi>
    <tradeName>Mercodia Glucagon ELISA</tradeName>
    <deviceName>Mercodia Glucagon ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>GLUCAGON</emdnDescription>
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    <udiDi>07350108630092</udiDi>
    <basicUdiDi>B-07350108630092</basicUdiDi>
    <tradeName>Mercodia Ultrasensitive C-peptide ELISA</tradeName>
    <deviceName>Mercodia Ultrasensitive C-peptide ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1141-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:08.636Z</lastUpdated>
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    <udiDi>07350108630085</udiDi>
    <basicUdiDi>B-07350108630085</basicUdiDi>
    <tradeName>Mercodia C-peptide ELISA</tradeName>
    <deviceName>Mercodia C-peptide ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1136-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:07.830Z</lastUpdated>
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    <udiDi>07350108630061</udiDi>
    <basicUdiDi>B-07350108630061</basicUdiDi>
    <tradeName>Mercodia Ultrasensitive Insulin ELISA</tradeName>
    <deviceName>Mercodia Ultrasensitive Insulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1132-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:07.143Z</lastUpdated>
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    <udiDi>07350108630054</udiDi>
    <basicUdiDi>B-07350108630054</basicUdiDi>
    <tradeName>Mercodia Iso-Insulin ELISA</tradeName>
    <deviceName>Mercodia Iso-Insulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1128-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:05.434Z</lastUpdated>
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    <udiDi>07350108630030</udiDi>
    <basicUdiDi>B-07350108630030</basicUdiDi>
    <tradeName>Mercodia Insulin ELISA – 10 pack</tradeName>
    <deviceName>Mercodia Insulin ELISA – 10 pack</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1113-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:01.433Z</lastUpdated>
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    <udiDi>07350108630023</udiDi>
    <basicUdiDi>B-07350108630023</basicUdiDi>
    <tradeName>Mercodia Insulin ELISA</tradeName>
    <deviceName>Mercodia Insulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1113-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:00.638Z</lastUpdated>
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    <udiDi>06979469760661</udiDi>
    <basicUdiDi>B-06979469760661</basicUdiDi>
    <tradeName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7403CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:41:21.298Z</lastUpdated>
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    <udiDi>06979469760654</udiDi>
    <basicUdiDi>B-06979469760654</basicUdiDi>
    <tradeName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7404CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:41:20.494Z</lastUpdated>
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    <udiDi>06979469760647</udiDi>
    <basicUdiDi>B-06979469760647</basicUdiDi>
    <tradeName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7402CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:41:16.493Z</lastUpdated>
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    <udiDi>06979469760630</udiDi>
    <basicUdiDi>B-06979469760630</basicUdiDi>
    <tradeName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7402CL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:41:15.682Z</lastUpdated>
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    <udiDi>06978945081290</udiDi>
    <basicUdiDi>B-06978945081290</basicUdiDi>
    <tradeName>Anti-Tyrosine Phosphatase Antibody Kit(CLIA)</tradeName>
    <deviceName>Anti-Tyrosine Phosphatase Antibody Kit(CLIA)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1600B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:26.414Z</lastUpdated>
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    <udiDi>06978945081283</udiDi>
    <basicUdiDi>B-06978945081283</basicUdiDi>
    <tradeName>Anti-Tyrosine Phosphatase Antibody Kit(CLIA)</tradeName>
    <deviceName>Anti-Tyrosine Phosphatase Antibody Kit(CLIA)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1600A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:21.725Z</lastUpdated>
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    <basicUdiDi>B-06978896415670</basicUdiDi>
    <tradeName>06978896415670</tradeName>
    <deviceName>Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-HbA1c-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:51.792Z</lastUpdated>
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    <basicUdiDi>B-06978896415663</basicUdiDi>
    <tradeName>06978896415663</tradeName>
    <deviceName>Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:51.000Z</lastUpdated>
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    <udiDi>06978198482011</udiDi>
    <basicUdiDi>B-06978198482011</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:11.691Z</lastUpdated>
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    <basicUdiDi>B-06978139071373</basicUdiDi>
    <tradeName>C-Peptide Test (FIA)</tradeName>
    <deviceName>C-Peptide Test (FIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320307802</reference>
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    <basicUdiDi>B-06978139071366</basicUdiDi>
    <tradeName>Insulin Test (FIA)</tradeName>
    <deviceName>Insulin Test (FIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320307702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:09.015Z</lastUpdated>
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