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<eudamedExport entity="devices">
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    <udiDi>06942253006245</udiDi>
    <basicUdiDi>B-06942253006245</basicUdiDi>
    <tradeName>AutoChem H-FABP</tradeName>
    <deviceName>AutoChem H-FABP</deviceName>
    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>360105HFP000S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:10:37.374Z</lastUpdated>
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  <row>
    <udiDi>00842768029912</udiDi>
    <basicUdiDi>0405686901272VD</basicUdiDi>
    <tradeName>Dimension EXL N-terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_LNTP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10464526</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:52:29.520Z</lastUpdated>
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    <udiDi>00630414599670</udiDi>
    <basicUdiDi>0405686900807VR</basicUdiDi>
    <tradeName>Atellica IM Myoglobin (MYO)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_MYO</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995649</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:49:00.350Z</lastUpdated>
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    <udiDi>00630414197180</udiDi>
    <basicUdiDi>0405686900829W3</basicUdiDi>
    <tradeName>ADVIA Centaur Myoglobin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310277</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:45:14.139Z</lastUpdated>
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  <row>
    <udiDi>00630414611112</udiDi>
    <basicUdiDi>0405686902330V9</basicUdiDi>
    <tradeName>Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_hCRP2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537224</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:24.021Z</lastUpdated>
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  <row>
    <udiDi>00630414599298</udiDi>
    <basicUdiDi>0405686901615VM</basicUdiDi>
    <tradeName>Atellica IM Homocysteine (HCY)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_KIT_HCY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:53.080Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455-BF-S175S3</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S175S3</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S175S3</tradeName>
    <deviceName>HCY Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S175</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:03.115Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455-BF-S174RZ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S174RZ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S174RZ</tradeName>
    <deviceName>HCY Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S174</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:00.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S173RX</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S173RX</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S173RX</tradeName>
    <deviceName>HCY Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S173</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:59.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S172RV</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S172RV</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S172RV</tradeName>
    <deviceName>HCY Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S172</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:56.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S171RT</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S171RT</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S171RT</tradeName>
    <deviceName>HCY Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S171</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:50.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A074DC</udiDi>
    <basicUdiDi>B-A074DC</basicUdiDi>
    <tradeName>D-A074DC</tradeName>
    <deviceName>INDICAID® HCY Rapid Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID® HCY Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:36.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6L32-439E</udiDi>
    <basicUdiDi>B-6L32-439E</basicUdiDi>
    <tradeName>Quantia Myoglobin</tradeName>
    <deviceName>Quantia Myoglobin</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6L32-43</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:28:19.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840308754</udiDi>
    <basicUdiDi>B-69743840308754</basicUdiDi>
    <tradeName>Troponin I Rapid Test</tradeName>
    <deviceName>Troponin I Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3050301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:32.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-95AX</udiDi>
    <basicUdiDi>B-6-95AX</basicUdiDi>
    <tradeName>D-6-95AX</tradeName>
    <deviceName>High sensitive C-Reactive Protein (hs-CRP) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000073M, USIA00000074M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:58.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-89B4</udiDi>
    <basicUdiDi>B-6-89B4</basicUdiDi>
    <tradeName>D-6-89B4</tradeName>
    <deviceName>High-sensitive Cardiac Troponin T (hs-cTnT) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000081M, USIA00000082M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:51.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-88B2</udiDi>
    <basicUdiDi>B-6-88B2</basicUdiDi>
    <tradeName>D-6-88B2</tradeName>
    <deviceName>N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000083M, USIA00000084M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:49.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-87AY</udiDi>
    <basicUdiDi>B-6-87AY</basicUdiDi>
    <tradeName>D-6-87AY</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000079M, USIA00000080M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:42.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-86AW</udiDi>
    <basicUdiDi>B-6-86AW</basicUdiDi>
    <tradeName>D-6-86AW</tradeName>
    <deviceName>Myoglobin (MYO) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000077M, USIA00000078M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:27.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-85AU</udiDi>
    <basicUdiDi>B-6-85AU</basicUdiDi>
    <tradeName>D-6-85AU</tradeName>
    <deviceName>Brain Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000085M, USIA00000086M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:27.593Z</lastUpdated>
  </row>
</eudamedExport>