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<eudamedExport entity="devices">
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    <udiDi>06942028502484</udiDi>
    <basicUdiDi>B-06942028502484</basicUdiDi>
    <tradeName>Bone Alkaline Phosphatase (BAP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Bone Alkaline Phosphatase (BAP) 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>W0102060318</emdnCode>
    <emdnDescription>BONE ALKALINE PHOSPHATASE (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH0401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:48.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028502446</udiDi>
    <basicUdiDi>B-06942028502446</basicUdiDi>
    <tradeName>Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) 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>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH0301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:45.690Z</lastUpdated>
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  <row>
    <udiDi>06942028502408</udiDi>
    <basicUdiDi>B-06942028502408</basicUdiDi>
    <tradeName>Bone Gla Protein (BGP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Bone Gla Protein (BGP) 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>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH0201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:37.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028502361</udiDi>
    <basicUdiDi>B-06942028502361</basicUdiDi>
    <tradeName>β-Crosslaps(β-CTx) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>β-Crosslaps(β-CTx) 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>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH0101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:36.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967225041</udiDi>
    <basicUdiDi>B-06941967225041</basicUdiDi>
    <tradeName>06941967225041</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.4F. 01.01.02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:48:54.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377306453</udiDi>
    <basicUdiDi>B-06941377306453</basicUdiDi>
    <tradeName>25-Hydroxyvitamin D Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PO-0009-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:18:58.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716405349</udiDi>
    <basicUdiDi>69713904311067S</basicUdiDi>
    <tradeName>HOKAPI™ TOTAL 25OH VITAMIN D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011106601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:45.109Z</lastUpdated>
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  <row>
    <udiDi>06939716405325</udiDi>
    <basicUdiDi>693971641102L7</basicUdiDi>
    <tradeName>HOKAPI™ PTH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011102601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:42.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716405318</udiDi>
    <basicUdiDi>693971641102L7</basicUdiDi>
    <tradeName>HOKAPI™ PTH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011102001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:41.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300650</udiDi>
    <basicUdiDi>B-06937287300650</basicUdiDi>
    <tradeName>06937287300650</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:44.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751673</udiDi>
    <basicUdiDi>B-06936595751673</basicUdiDi>
    <tradeName>Total Procollagen I N-Terminal Propeptide Kit (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060317</emdnCode>
    <emdnDescription>PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1454Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:27.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751642</udiDi>
    <basicUdiDi>B-06936595751642</basicUdiDi>
    <tradeName>25-Hydroxy Vitamin D Total Kit (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1451Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:22.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751635</udiDi>
    <basicUdiDi>B-06936595751635</basicUdiDi>
    <tradeName>Intact Parathyroid Hormone Kit (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1450Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:21.125Z</lastUpdated>
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  <row>
    <udiDi>06936595750775</udiDi>
    <basicUdiDi>B-06936595750775</basicUdiDi>
    <tradeName>25-Hydroxy Vitamin D Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ454Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:55:16.230Z</lastUpdated>
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    <udiDi>06925912718543</udiDi>
    <basicUdiDi>692591270020GP</basicUdiDi>
    <tradeName>iFlash-25-OH Vitamin D</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:12:58.298Z</lastUpdated>
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  <row>
    <udiDi>06933289836562</udiDi>
    <basicUdiDi>B-06933289836562</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W241P0008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:07:11.523Z</lastUpdated>
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    <udiDi>00816776020384</udiDi>
    <basicUdiDi>081677602VTDKIT0608D9</basicUdiDi>
    <tradeName>MassTrak™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Waters Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025801</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>186008442IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:15.466Z</lastUpdated>
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    <udiDi>00816776020391</udiDi>
    <basicUdiDi>081677602VTDKIT0608D9</basicUdiDi>
    <tradeName>MassTrak™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Waters Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025801</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>186008097IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:15.448Z</lastUpdated>
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    <udiDi>00816776020407</udiDi>
    <basicUdiDi>081677602VTDKIT0608D9</basicUdiDi>
    <tradeName>MassTrak™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Waters Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025801</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>186008647IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:15.427Z</lastUpdated>
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    <udiDi>00816776020414</udiDi>
    <basicUdiDi>081677602VTDKIT0608D9</basicUdiDi>
    <tradeName>MassTrak™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Waters Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025801</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>186008441IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:15.406Z</lastUpdated>
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