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<eudamedExport entity="devices">
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    <udiDi>08431673074937</udiDi>
    <basicUdiDi>B-08431673074937</basicUdiDi>
    <tradeName>FOB-TURBI</tradeName>
    <deviceName>Fecal ocult blood</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI1107185</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:33:22.534Z</lastUpdated>
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  <row>
    <udiDi>00630414961040</udiDi>
    <basicUdiDi>0405686901440VA</basicUdiDi>
    <tradeName>IMMULITE 2000 AFP</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_AFP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381184</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:49:35.628Z</lastUpdated>
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  <row>
    <udiDi>06935784461102</udiDi>
    <basicUdiDi>B-06935784461102</basicUdiDi>
    <tradeName>06935784461102</tradeName>
    <deviceName>Matrix Metalloproteinase -9 Test Kit (Latex Lateral Flow  Assay)</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>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-S011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:57.868Z</lastUpdated>
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  <row>
    <udiDi>00630414961033</udiDi>
    <basicUdiDi>0405686901440VA</basicUdiDi>
    <tradeName>IMMULITE 2000 AFP</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_AFP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:37.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S235RU</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S235RU</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S235RU</tradeName>
    <deviceName>β2-MG 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S235</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:13.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S234RS</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S234RS</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S234RS</tradeName>
    <deviceName>β2-MG 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S234</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:12.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S233RQ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S233RQ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S233RQ</tradeName>
    <deviceName>β2-MG 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S233</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:10.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S232RN</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S232RN</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S232RN</tradeName>
    <deviceName>β2-MG 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S232</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:05.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S231RL</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S231RL</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S231RL</tradeName>
    <deviceName>β2-MG 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:05.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840304176</udiDi>
    <basicUdiDi>B-69743840304176</basicUdiDi>
    <tradeName>AFP Rapid Test Device</tradeName>
    <deviceName>AFP Rapid Test Device</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3040401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:58.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840303186</udiDi>
    <basicUdiDi>B-69743840303186</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName>FOB 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>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3040101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:35.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FOB001GESV</udiDi>
    <basicUdiDi>B-697424646FOB001GESV</basicUdiDi>
    <tradeName>Fecal Occult Blood(FOB) Rapid Test (Feces)</tradeName>
    <deviceName>Fecal Occult Blood(FOB) Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-5011/FOB-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:07.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-63H50TSCTE</udiDi>
    <basicUdiDi>B-63H50TSCTE</basicUdiDi>
    <tradeName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</tradeName>
    <deviceName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:41:05.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-63H240TSC95</udiDi>
    <basicUdiDi>B-63H240TSC95</basicUdiDi>
    <tradeName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</tradeName>
    <deviceName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63H240TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:41:05.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6000A9</udiDi>
    <basicUdiDi>B-6000A9</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Serotonin in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039011</emdnCode>
    <emdnDescription>SEROTONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:15:19.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-78AX</udiDi>
    <basicUdiDi>B-6-78AX</basicUdiDi>
    <tradeName>D-6-78AX</tradeName>
    <deviceName>Neuron-specific Enolase (NSE) 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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000143M, USIA00000144M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:14.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-66AQ</udiDi>
    <basicUdiDi>B-6-66AQ</basicUdiDi>
    <tradeName>D-6-66AQ</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000147M, USIA00000148M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:13:54.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-25AA</udiDi>
    <basicUdiDi>B-6-25AA</basicUdiDi>
    <tradeName>D-6-25AA</tradeName>
    <deviceName>α-L-Fucosidase (AFU) Assay Kit (CNPF substrate Method)</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>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U87481030M, U87489050M, U87485020M, U87421050M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:08.967Z</lastUpdated>
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  <row>
    <udiDi>06937339210876</udiDi>
    <basicUdiDi>B-06937339210876</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName>FOB Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:42.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021334</udiDi>
    <basicUdiDi>B-00816426021334</basicUdiDi>
    <tradeName>K-ASSAY Microglobulin Urine Control</tradeName>
    <deviceName>Beta-2 Microglobulin Urine Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K284C-2M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:33:03.375Z</lastUpdated>
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</eudamedExport>