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    <tradeName>Alinity c Myoglobin Reagent Kit</tradeName>
    <deviceName>Alinity c Myoglobin Reagent Kit</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
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    <reference>01R1523</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:43:43.477Z</lastUpdated>
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    <tradeName>Quantia Myoglobin</tradeName>
    <deviceName>Quantia Myoglobin</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
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    <tradeName>High Sensitive Troponin T test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>High Sensitive Troponin T test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL67</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:00.096Z</lastUpdated>
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    <tradeName>N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)</tradeName>
    <deviceName>N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCG01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:19.215Z</lastUpdated>
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    <tradeName>Cardiac Troponin-I test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Cardiac Troponin-I test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:13.531Z</lastUpdated>
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    <tradeName>N-terminal Pro-B-type Natriuretic Peptide test (Up-converting Phosphor Technology)</tradeName>
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    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>N-terminal Pro-B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>N-terminal Pro-B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:07:49.071Z</lastUpdated>
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    <tradeName>Myoglobin test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Triiodothyronine test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:07:45.095Z</lastUpdated>
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    <tradeName>Creatine kinase mb test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Creatine kinase mb test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:07:44.275Z</lastUpdated>
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    <tradeName>High sensitive Cardiac Troponin-I test  (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
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    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:07:43.537Z</lastUpdated>
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    <tradeName>HS-cTnT CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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