<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-BL2516001BW</udiDi>
    <basicUdiDi>B-BL2516001BW</basicUdiDi>
    <tradeName>D-BL2516001BW</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2516001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:29.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2515001BP</udiDi>
    <basicUdiDi>B-BL2515001BP</basicUdiDi>
    <tradeName>D-BL2515001BP</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2515001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:28.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2514001BG</udiDi>
    <basicUdiDi>B-BL2514001BG</basicUdiDi>
    <tradeName>D-BL2514001BG</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2514001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:24.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2513001B9</udiDi>
    <basicUdiDi>B-BL2513001B9</basicUdiDi>
    <tradeName>D-BL2513001B9</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2513001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:23.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2512001B2</udiDi>
    <basicUdiDi>B-BL2512001B2</basicUdiDi>
    <tradeName>D-BL2512001B2</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2512001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:22.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2511001AT</udiDi>
    <basicUdiDi>B-BL2511001AT</basicUdiDi>
    <tradeName>D-BL2511001AT</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2511001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:21.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2510001AL</udiDi>
    <basicUdiDi>B-BL2510001AL</basicUdiDi>
    <tradeName>D-BL2510001AL</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2510001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:17.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2509001C8</udiDi>
    <basicUdiDi>B-BL2509001C8</basicUdiDi>
    <tradeName>D-BL2509001C8</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2509001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:17.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2508001BZ</udiDi>
    <basicUdiDi>B-BL2508001BZ</basicUdiDi>
    <tradeName>D-BL2508001BZ</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC) Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2508001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:15.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2507001BS</udiDi>
    <basicUdiDi>B-BL2507001BS</basicUdiDi>
    <tradeName>D-BL2507001BS</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2507001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:14.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2506001BK</udiDi>
    <basicUdiDi>B-BL2506001BK</basicUdiDi>
    <tradeName>D-BL2506001BK</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2506001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:10.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2505001BC</udiDi>
    <basicUdiDi>B-BL2505001BC</basicUdiDi>
    <tradeName>D-BL2505001BC</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2505001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:09.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2504001B5</udiDi>
    <basicUdiDi>B-BL2504001B5</basicUdiDi>
    <tradeName>D-BL2504001B5</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2504001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:09.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2503001AW</udiDi>
    <basicUdiDi>B-BL2503001AW</basicUdiDi>
    <tradeName>D-BL2503001AW</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2503001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:08.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2502001AP</udiDi>
    <basicUdiDi>B-BL2502001AP</basicUdiDi>
    <tradeName>D-BL2502001AP</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2581001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:04.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL2501001AG</udiDi>
    <basicUdiDi>B-BL2501001AG</basicUdiDi>
    <tradeName>D-BL2501001AG</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HPLC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2501001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:03.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B36415UY</udiDi>
    <basicUdiDi>B-B36415UY</basicUdiDi>
    <tradeName>Hemoglobin A1c Reagent (HbA1c3 250)</tradeName>
    <deviceName>Hemoglobin A1c Reagent (HbA1c3 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B36415</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:50:45.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A87905X7</udiDi>
    <basicUdiDi>B-A87905X7</basicUdiDi>
    <tradeName>Hemoglobin A1c- Reagent (HbA1c-400)</tradeName>
    <deviceName>Hemoglobin A1c- Reagent (HbA1c-400)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A87905</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:44.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-780610008PT</udiDi>
    <basicUdiDi>B-780610008PT</basicUdiDi>
    <tradeName>BM Test HbA1c Diluent</tradeName>
    <deviceName>BM Test HbA1c Diluent</deviceName>
    <manufacturerName>JEOL Ltd. MF</manufacturerName>
    <manufacturerSrn>JP-MF-000026608</manufacturerSrn>
    <authorisedRepresentativeName>JEOL(Europe)BV AR</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023086</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>780610008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:36.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-780609999TR</udiDi>
    <basicUdiDi>B-780609999TR</basicUdiDi>
    <tradeName>BM Test HbA1c Control</tradeName>
    <deviceName>BM Test HbA1c Control</deviceName>
    <manufacturerName>JEOL Ltd. MF</manufacturerName>
    <manufacturerSrn>JP-MF-000026608</manufacturerSrn>
    <authorisedRepresentativeName>JEOL(Europe)BV AR</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023086</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>780609999</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:35.593Z</lastUpdated>
  </row>
</eudamedExport>