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<eudamedExport entity="devices">
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    <udiDi>06970522642788</udiDi>
    <basicUdiDi>B-06970522642788</basicUdiDi>
    <tradeName>Carbohydrate Antigen 125 (CA125) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Carbohydrate Antigen 125 (CA125) 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>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:12.052Z</lastUpdated>
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  <row>
    <udiDi>06970522642689</udiDi>
    <basicUdiDi>B-06970522642689</basicUdiDi>
    <tradeName>Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Neuron-Specific Enolase (NSE) 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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:10.849Z</lastUpdated>
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    <udiDi>06970522642597</udiDi>
    <basicUdiDi>B-06970522642597</basicUdiDi>
    <tradeName>Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Myoglobin (MYO) 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA2101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:08.449Z</lastUpdated>
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  <row>
    <udiDi>06970522642580</udiDi>
    <basicUdiDi>B-06970522642580</basicUdiDi>
    <tradeName>Carbohydrate Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Carbohydrate Antigen 72-4 (CA72-4) 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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:04.849Z</lastUpdated>
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  <row>
    <udiDi>06970522642382</udiDi>
    <basicUdiDi>B-06970522642382</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma Antigen (SCC) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Squamous Cell Carcinoma Antigen (SCC) 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>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:02.440Z</lastUpdated>
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  <row>
    <udiDi>06970522642290</udiDi>
    <basicUdiDi>B-06970522642290</basicUdiDi>
    <tradeName>Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Alpha Tumor Necrosis Factor (TNFα) 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>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC0601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:01.236Z</lastUpdated>
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  <row>
    <udiDi>06970522642283</udiDi>
    <basicUdiDi>B-06970522642283</basicUdiDi>
    <tradeName>β2-Microglobulin (β2-MG) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:58.836Z</lastUpdated>
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  <row>
    <udiDi>06970522641941</udiDi>
    <basicUdiDi>B-06970522641941</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragment (CYFRA21-1) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Cytokeratin 19 Fragment (CYFRA21-1) 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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1603</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:55.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641743</udiDi>
    <basicUdiDi>B-06970522641743</basicUdiDi>
    <tradeName>Carbohydrate Antigen 50 (CA50) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Carbohydrate Antigen 50 (CA50) 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>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD1801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:52.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641699</udiDi>
    <basicUdiDi>B-06970522641699</basicUdiDi>
    <tradeName>Interleukin -10 (IL-10) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Interleukin -10 (IL-10) 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>W01030606</emdnCode>
    <emdnDescription>OTHER INTERLEUKINS (EXCEPT FOR IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC0701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:51.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641651</udiDi>
    <basicUdiDi>B-06970522641651</basicUdiDi>
    <tradeName>2×50 test/box Calibrator:0.5mL×2</tradeName>
    <deviceName>Total β-Human Chorionic Gonadotropin (Total β-HCG) 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>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL1703</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:49.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641392</udiDi>
    <basicUdiDi>B-06970522641392</basicUdiDi>
    <tradeName>Interleukin -8 (IL-8) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Interleukin -8 (IL-8) 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>W01030606</emdnCode>
    <emdnDescription>OTHER INTERLEUKINS (EXCEPT FOR IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:45.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641101</udiDi>
    <basicUdiDi>B-06970522641101</basicUdiDi>
    <tradeName>Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) 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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:43.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641095</udiDi>
    <basicUdiDi>B-06970522641095</basicUdiDi>
    <tradeName>Interleukin-2 Receptor (IL-2R) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Interleukin-2 Receptor (IL-2R) 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>W01030607</emdnCode>
    <emdnDescription>INTERLEUKINS RECEPTORS (IL-2R,IL6R ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC0901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:42.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522641057</udiDi>
    <basicUdiDi>B-06970522641057</basicUdiDi>
    <tradeName>Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Alpha Fetoprotein (AFP) 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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:39.630Z</lastUpdated>
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  <row>
    <udiDi>06970522640975</udiDi>
    <basicUdiDi>B-06970522640975</basicUdiDi>
    <tradeName>Anti-ovarian antibody IgG (AOA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-ovarian antibody IgG (AOA-IgG) Dectection 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:36.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640913</udiDi>
    <basicUdiDi>B-06970522640913</basicUdiDi>
    <tradeName>Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-sperm antibody IgM (ASA-IgM) Dectection 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>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:33.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640791</udiDi>
    <basicUdiDi>B-06970522640791</basicUdiDi>
    <tradeName>Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-sperm antibody IgG (ASA-IgG) Dectection 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>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:32.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640692</udiDi>
    <basicUdiDi>B-06970522640692</basicUdiDi>
    <tradeName>Anti-ovarian antibody IgM (AOA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-ovarian antibody IgM (AOA-IgM) Dectection 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:30.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640562</udiDi>
    <basicUdiDi>B-06970522640562</basicUdiDi>
    <tradeName>Lactoferrin (LF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Lactoferrin (LF) 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>BB0602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:26.414Z</lastUpdated>
  </row>
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