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<eudamedExport entity="devices">
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    <basicUdiDi>69703416803205102J4</basicUdiDi>
    <tradeName>N-MID Osteocalcin (eCLIA)</tradeName>
    <deviceName>N-MID Osteocalcin (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:09.828Z</lastUpdated>
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  <row>
    <udiDi>06942359542265</udiDi>
    <basicUdiDi>697015090000045H6</basicUdiDi>
    <tradeName>Osteocalcin CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:12.856Z</lastUpdated>
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    <udiDi>06925912720461</udiDi>
    <basicUdiDi>692591270277HW</basicUdiDi>
    <tradeName>iFlash-Osteocalcin</tradeName>
    <deviceName>iFlash-Osteocalcin</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86289</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:17.566Z</lastUpdated>
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    <udiDi>05060169690516</udiDi>
    <basicUdiDi>5060169690516X3</basicUdiDi>
    <tradeName>N-MID® Osteocalcin ELISA</tradeName>
    <deviceName>N-MID Osteocalcin ELISA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-11F12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:37.068Z</lastUpdated>
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  <row>
    <udiDi>00630414961781</udiDi>
    <basicUdiDi>0405686900227UZ</basicUdiDi>
    <tradeName>IMMULITE 2000 Osteocalcin</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Osteocalcin</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381477</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:34.046Z</lastUpdated>
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  <row>
    <udiDi>D-SEK015DK</udiDi>
    <basicUdiDi>B-SEK015DK</basicUdiDi>
    <tradeName>Osteocalcin Assay Kit (ECLIA)</tradeName>
    <deviceName>Osteocalcin Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:49.973Z</lastUpdated>
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  <row>
    <udiDi>D-GKPD195Y3</udiDi>
    <basicUdiDi>B-GKPD195Y3</basicUdiDi>
    <tradeName>Osteocalcin Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Osteocalcin Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD195</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:11.512Z</lastUpdated>
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  <row>
    <udiDi>20850076346427</udiDi>
    <basicUdiDi>B-20850076346427</basicUdiDi>
    <tradeName>N-MID Osteocalcin Test Kit (CLIA)</tradeName>
    <deviceName>N-MID Osteocalcin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIMID(N)-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:03:31.863Z</lastUpdated>
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  <row>
    <udiDi>06925912720478</udiDi>
    <basicUdiDi>692591270277HW</basicUdiDi>
    <tradeName>iFlash-Osteocalcin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86289-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:11.656Z</lastUpdated>
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  <row>
    <udiDi>14560189215679</udiDi>
    <basicUdiDi>B-14560189215679</basicUdiDi>
    <tradeName>14560189215679</tradeName>
    <deviceName>CL AIA-PACK Osteocalcin ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029254</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:03:03.644Z</lastUpdated>
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  <row>
    <udiDi>14560189215594</udiDi>
    <basicUdiDi>B-14560189215594</basicUdiDi>
    <tradeName>14560189215594</tradeName>
    <deviceName>CL AIA-PACK Osteocalcin TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029154</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:57.223Z</lastUpdated>
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  <row>
    <udiDi>14560189213217</udiDi>
    <basicUdiDi>B-14560189213217</basicUdiDi>
    <tradeName>14560189213217</tradeName>
    <deviceName>ST AIA-PACK Osteocalcin</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025236</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:25.148Z</lastUpdated>
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  <row>
    <udiDi>10850076346420</udiDi>
    <basicUdiDi>B-10850076346420</basicUdiDi>
    <tradeName>N-MID Osteocalcin Test Kit (CLIA)</tradeName>
    <deviceName>N-MID Osteocalcin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIMID(N)-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:40:04.188Z</lastUpdated>
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  <row>
    <udiDi>06975984063959</udiDi>
    <basicUdiDi>69703416803205102J4</basicUdiDi>
    <tradeName>N-MID Osteocalcin (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:10.875Z</lastUpdated>
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    <udiDi>06942359542289</udiDi>
    <basicUdiDi>697015090000045H6</basicUdiDi>
    <tradeName>Osteocalcin CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:20.509Z</lastUpdated>
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    <udiDi>06979878281191</udiDi>
    <basicUdiDi>B-06979878281191</basicUdiDi>
    <tradeName>06979878281191</tradeName>
    <deviceName>N-MID Osteocalcin Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001017</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:29.314Z</lastUpdated>
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    <udiDi>06976753477342</udiDi>
    <basicUdiDi>B-06976753477342</basicUdiDi>
    <tradeName>Osteocalcin Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KA003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:01:11.604Z</lastUpdated>
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    <udiDi>06975984063966</udiDi>
    <basicUdiDi>B-06975984063966</basicUdiDi>
    <tradeName>N-MID Osteocalcin (eCLIA)</tradeName>
    <deviceName>N-MID Osteocalcin (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:20:29.017Z</lastUpdated>
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    <udiDi>06975984063942</udiDi>
    <basicUdiDi>B-06975984063942</basicUdiDi>
    <tradeName>N-MID Osteocalcin (eCLIA)</tradeName>
    <deviceName>N-MID Osteocalcin (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:20:23.437Z</lastUpdated>
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    <udiDi>06974969982407</udiDi>
    <basicUdiDi>B-06974969982407</basicUdiDi>
    <tradeName>Bone Gamma-carboxyglutamic-acid-containing Proteins (BGP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Bone Gamma-carboxyglutamic-acid-containing Proteins (BGP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1086-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:14:15.151Z</lastUpdated>
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