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    <basicUdiDi>69449040004L-VD-T******JC</basicUdiDi>
    <tradeName>25-OH-Vitamin D Total (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-008686-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.266Z</lastUpdated>
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  <row>
    <udiDi>06944904091396</udiDi>
    <basicUdiDi>69449040004L-VB12******ZN</basicUdiDi>
    <tradeName>Vitamin B12(CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152206</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-008687-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.245Z</lastUpdated>
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    <udiDi>06944904091419</udiDi>
    <basicUdiDi>69449040004L-PTH*******J3</basicUdiDi>
    <tradeName>Parathyroid hormone(CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-008689-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.195Z</lastUpdated>
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    <udiDi>03610230006795</udiDi>
    <basicUdiDi>B-03610230006795</basicUdiDi>
    <tradeName>ABX Pentra ASO 2 Cal</tradeName>
    <deviceName>ABX Pentra ASO 2 Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152210</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300022600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:21.181Z</lastUpdated>
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  <row>
    <udiDi>03610230005828</udiDi>
    <basicUdiDi>B-03610230005828</basicUdiDi>
    <tradeName>ABX Pentra CRP HS Cal</tradeName>
    <deviceName>ABX Pentra CRP HS Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01983</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:09.163Z</lastUpdated>
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  <row>
    <udiDi>00884883008977</udiDi>
    <basicUdiDi>B-00884883008977</basicUdiDi>
    <tradeName>00884883008977</tradeName>
    <deviceName>Alinity c Tox SemiQuant Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P6801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:21.402Z</lastUpdated>
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  <row>
    <udiDi>00884883008960</udiDi>
    <basicUdiDi>B-00884883008960</basicUdiDi>
    <tradeName>00884883008960</tradeName>
    <deviceName>Alinity c Tox Qual Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P6802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:20.617Z</lastUpdated>
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    <udiDi>00884883008953</udiDi>
    <basicUdiDi>B-00884883008953</basicUdiDi>
    <tradeName>00884883008953</tradeName>
    <deviceName>Alinity c Tox Controls</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P6810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:19.799Z</lastUpdated>
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  <row>
    <udiDi>00858724003346</udiDi>
    <basicUdiDi>B-00858724003346</basicUdiDi>
    <tradeName>ARK Lacosamide Calibrator</tradeName>
    <deviceName>ARK Lacosamide Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5033-0002-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:05.492Z</lastUpdated>
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  <row>
    <udiDi>00858724003230</udiDi>
    <basicUdiDi>B-00858724003230</basicUdiDi>
    <tradeName>ARK Voriconazole II Calibrator</tradeName>
    <deviceName>ARK Voriconazole II Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5030-0002-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:59.884Z</lastUpdated>
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  <row>
    <udiDi>00858724003063</udiDi>
    <basicUdiDi>B-00858724003063</basicUdiDi>
    <tradeName>ARK Topiramate Calibrator</tradeName>
    <deviceName>ARK Topiramate Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5015-0002-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:53.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020580</udiDi>
    <basicUdiDi>B-00816426020580</basicUdiDi>
    <tradeName>K-ASSAY Apo AII/CII/CIII Calibrator</tradeName>
    <deviceName>Apo AII/CII/CIII Calibrator</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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-041C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:45.290Z</lastUpdated>
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  <row>
    <udiDi>00816426020566</udiDi>
    <basicUdiDi>B-00816426020566</basicUdiDi>
    <tradeName>K-ASSAY Multi-Analyte Calibrator</tradeName>
    <deviceName>Multi-Analyte Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-016C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:40.486Z</lastUpdated>
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  <row>
    <udiDi>00812101030165</udiDi>
    <basicUdiDi>B-00812101030165</basicUdiDi>
    <tradeName>ARK Meperidine Calibrator</tradeName>
    <deviceName>ARK Meperidine Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0002-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:21:10.201Z</lastUpdated>
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    <udiDi>00812101030158</udiDi>
    <basicUdiDi>B-00812101030158</basicUdiDi>
    <tradeName>ARK Meperidine Calibrator</tradeName>
    <deviceName>ARK Meperidine Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0002-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:21:09.410Z</lastUpdated>
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    <udiDi>00812101030141</udiDi>
    <basicUdiDi>B-00812101030141</basicUdiDi>
    <tradeName>ARK Meperidine Calibrator</tradeName>
    <deviceName>ARK Meperidine Calibrator</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0002-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:21:08.599Z</lastUpdated>
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    <udiDi>00195126000093</udiDi>
    <basicUdiDi>B-00195126000093</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Circulating Calprotectin Calibrators</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701366</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:26.350Z</lastUpdated>
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    <udiDi>08806133050071</udiDi>
    <basicUdiDi>880613307078DR</basicUdiDi>
    <tradeName>Boditech sphingotest® penKid® Calibrator</tradeName>
    <deviceName>Boditech sphingotest® penKid® Calibrator</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-403</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:33.622Z</lastUpdated>
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    <udiDi>08806133048528</udiDi>
    <basicUdiDi>880613307141D7</basicUdiDi>
    <tradeName>Boditech Free PSA Calibrator</tradeName>
    <deviceName>Boditech Free PSA Calibrator</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-409</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:28.516Z</lastUpdated>
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    <udiDi>08806133048504</udiDi>
    <basicUdiDi>880613307011CR</basicUdiDi>
    <tradeName>Boditech PSA Calibrator</tradeName>
    <deviceName>Boditech PSA Calibrator</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-277</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:23.209Z</lastUpdated>
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