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    <deviceName>ELSA-PTH</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-05T19:31:38.424Z</lastUpdated>
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    <basicUdiDi>B-00850082432226</basicUdiDi>
    <tradeName>25 OH Quantitative Rapid Vitamin D Test</tradeName>
    <deviceName>25 OH Quantitative Rapid Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
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    <tradeName>VHC Vitamin D Test</tradeName>
    <deviceName>VHC Vitamin D Test</deviceName>
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    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
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    <udiDi>00850082432059</udiDi>
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    <tradeName>BIOSYNEX Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>BIOSYNEX Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
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    <udiDi>00850082432042</udiDi>
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    <tradeName>botissCARE Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>botissCARE Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
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    <udiDi>00850082432035</udiDi>
    <basicUdiDi>B-00850082432035</basicUdiDi>
    <tradeName>CrinoCheck® Vitamin D</tradeName>
    <deviceName>CrinoCheck® Vitamin D</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
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    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
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    <udiDi>00850082432028</udiDi>
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    <tradeName>OnSight™- Vitamin D Quantitative Test</tradeName>
    <deviceName>OnSight™- Vitamin D Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
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    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>711-25-DB</reference>
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    <lastUpdated>2026-07-05T08:05:12.325Z</lastUpdated>
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    <tradeName>Calcitonin ELISA</tradeName>
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    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-04T06:06:11.048Z</lastUpdated>
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    <tradeName>Intact PTH (Parathyroid Hormone) ELISA</tradeName>
    <deviceName>Intact PTH (Parathyroid Hormone) ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:07.037Z</lastUpdated>
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    <udiDi>D-000012807162081PM</udiDi>
    <basicUdiDi>B-000012807162081PM</basicUdiDi>
    <tradeName>25-OH VD Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>25-OH VD Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:47.567Z</lastUpdated>
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    <udiDi>08033891329709</udiDi>
    <basicUdiDi>803389132VITAMIND00GP</basicUdiDi>
    <tradeName>CHORUS 25OH VITAMIN D TOTAL</tradeName>
    <deviceName>CHORUS 25OH VITAMIN D TOTAL</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86900</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:59.766Z</lastUpdated>
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    <udiDi>08033891328467</udiDi>
    <basicUdiDi>803389132CVitD-C0039</basicUdiDi>
    <tradeName>CHORUS CLIA 25OH VITAMIN D TOTAL</tradeName>
    <deviceName>CHORUS CLIA 25OH VITAMIN D TOTAL</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T05:19:48.552Z</lastUpdated>
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    <udiDi>07613336199756</udiDi>
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    <tradeName>Elecsys PTH</tradeName>
    <deviceName>PTH Elecsys E2G 300 V2</deviceName>
    <manufacturerName>Roche Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006260</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08928428214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:50.344Z</lastUpdated>
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    <tradeName>Calcitonin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Calcitonin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <emdnDescription>CALCITONIN</emdnDescription>
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    <lastUpdated>2026-07-02T20:34:23.298Z</lastUpdated>
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    <tradeName>Parathyroid Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Parathyroid Hormone Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <deviceName>iStar-25-OH Vitamin D</deviceName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
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    <lastUpdated>2026-07-02T11:25:23.399Z</lastUpdated>
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    <tradeName>HOKAPI™ TOTAL 25OH VITAMIN D</tradeName>
    <deviceName>HOKAPI™ TOTAL 25OH VITAMIN D</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>HOKAPI™ PTH</tradeName>
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    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
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    <lastUpdated>2026-07-02T07:23:32.535Z</lastUpdated>
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    <emdnDescription>1.25-DIHYDROXYVITAMIN D</emdnDescription>
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