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    <basicUdiDi>697052264SJPOZ0006VK</basicUdiDi>
    <tradeName>Hemoglobin &amp; Transferrin (FOB&amp;TF) non-quantitative  quality control</tradeName>
    <deviceName>Hemoglobin &amp; Transferrin (FOB&amp;TF) non-quantitative  quality control</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0333C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:47:00.084Z</lastUpdated>
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    <udiDi>06970522646960</udiDi>
    <basicUdiDi>697052264YQ09KX</basicUdiDi>
    <tradeName>Automatic Chemistry Analyzer</tradeName>
    <deviceName>Automatic Chemistry Analyzer</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD0401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:58.897Z</lastUpdated>
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    <udiDi>06970522646458</udiDi>
    <basicUdiDi>B-06970522646458</basicUdiDi>
    <tradeName>Group A Rotavirus &amp; Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Group A Rotavirus &amp; Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:56.485Z</lastUpdated>
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    <udiDi>06970522646380</udiDi>
    <basicUdiDi>B-06970522646380</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen (CEA) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:52.880Z</lastUpdated>
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    <udiDi>06970522646205</udiDi>
    <basicUdiDi>B-06970522646205</basicUdiDi>
    <tradeName>Human Epididymal Protein 4 (HE4) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Human Epididymal Protein 4 (HE4) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:50.472Z</lastUpdated>
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    <udiDi>06970522646199</udiDi>
    <basicUdiDi>B-06970522646199</basicUdiDi>
    <tradeName>Thyroglobuline (TG) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Thyroglobuline (TG) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA2301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:49.272Z</lastUpdated>
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    <udiDi>06970522646151</udiDi>
    <basicUdiDi>B-06970522646151</basicUdiDi>
    <tradeName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:46.877Z</lastUpdated>
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    <udiDi>06970522645994</udiDi>
    <basicUdiDi>B-06970522645994</basicUdiDi>
    <tradeName>The MB Isoenzyme of Creatine Kinase (CK-MB) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>The MB Isoenzyme of Creatine Kinase (CK-MB) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA2201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:43.268Z</lastUpdated>
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    <udiDi>06970522645680</udiDi>
    <basicUdiDi>B-06970522645680</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:40.865Z</lastUpdated>
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    <udiDi>06970522645505</udiDi>
    <basicUdiDi>B-06970522645505</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:39.704Z</lastUpdated>
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    <udiDi>06970522645444</udiDi>
    <basicUdiDi>B-06970522645444</basicUdiDi>
    <tradeName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:37.274Z</lastUpdated>
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    <udiDi>06970522645284</udiDi>
    <basicUdiDi>B-06970522645284</basicUdiDi>
    <tradeName>Ferritin Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Ferritin Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:33.661Z</lastUpdated>
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    <udiDi>06970522645109</udiDi>
    <basicUdiDi>B-06970522645109</basicUdiDi>
    <tradeName>Pepsinogen Ⅰ (PGⅠ) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pepsinogen Ⅰ (PGⅠ) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:31.265Z</lastUpdated>
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    <udiDi>06970522644805</udiDi>
    <basicUdiDi>B-06970522644805</basicUdiDi>
    <tradeName>Progastrin-Releasing Peptide (ProGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Progastrin-Releasing Peptide (ProGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:30.061Z</lastUpdated>
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    <udiDi>06970522644652</udiDi>
    <basicUdiDi>B-06970522644652</basicUdiDi>
    <tradeName>Procalcitonin(PCT) Assay Kit(Chemiluminescence)</tradeName>
    <deviceName>Procalcitonin(PCT) Assay Kit(Chemiluminescence)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC0209</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:27.665Z</lastUpdated>
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    <udiDi>06970522644041</udiDi>
    <basicUdiDi>B-06970522644041</basicUdiDi>
    <tradeName>Gastrin-17 (G-17) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Gastrin-17 (G-17) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD2004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:24.054Z</lastUpdated>
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    <basicUdiDi>B-06970522643846</basicUdiDi>
    <tradeName>N-Terminal Pro-B-Type Natriuretic Peptede (NT-proBNP)Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>N-Terminal Pro-B-Type Natriuretic Peptede (NT-proBNP)Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1904</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:21.656Z</lastUpdated>
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    <basicUdiDi>B-06970522643549</basicUdiDi>
    <tradeName>Thyroid Stimulating Hormone Receptor Antibody (Anti-TSHR)  Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Thyroid Stimulating Hormone Receptor Antibody (Anti-TSHR)  Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100304</emdnCode>
    <emdnDescription>THYROID STIMULATING IMMUNOGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL1803</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:20.454Z</lastUpdated>
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    <basicUdiDi>B-06970522642948</basicUdiDi>
    <tradeName>Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:18.047Z</lastUpdated>
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    <basicUdiDi>B-06970522642887</basicUdiDi>
    <tradeName>胃蛋白酶原II测定试剂盒（化学发光法）</tradeName>
    <deviceName>Pepsinogen Ⅱ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:14.459Z</lastUpdated>
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