<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06914329008811</udiDi>
    <basicUdiDi>B-06914329008811</basicUdiDi>
    <tradeName>06914329008811</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Model  mALB-1：125000007、Model  mALB-2：125000009、Model  mALB-3：125000008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935784460808</udiDi>
    <basicUdiDi>B-06935784460808</basicUdiDi>
    <tradeName>06935784460808</tradeName>
    <deviceName>Microalbumin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:55.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S105RE</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S105RE</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S105RE</tradeName>
    <deviceName>Microalbumin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:30.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S104RC</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S104RC</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S104RC</tradeName>
    <deviceName>Microalbumin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:25.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S103RA</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S103RA</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S103RA</tradeName>
    <deviceName>Microalbumin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:24.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S102R8</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S102R8</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S102R8</tradeName>
    <deviceName>Microalbumin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:20.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ALB001DCMW</udiDi>
    <basicUdiDi>B-697424646ALB001DCMW</basicUdiDi>
    <tradeName>Micro-Albumin Rapid Test(Urine)</tradeName>
    <deviceName>Micro-Albumin Rapid Test(Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALB-1011/ALB-1012/ALB-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:39.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M23C3Z5</udiDi>
    <basicUdiDi>B-5M23C3Z5</basicUdiDi>
    <tradeName>Microalbumin Test (FIA)</tradeName>
    <deviceName>Microalbumin Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5M23C3-25-EU, 5M23C3-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:13.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-331901N-50XZ</udiDi>
    <basicUdiDi>B-nvm-331901N-50XZ</basicUdiDi>
    <tradeName>NADAL® Microalbumin Test</tradeName>
    <deviceName>Microalbumin Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>331901N-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:14.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VNMB-101PN</udiDi>
    <basicUdiDi>B-VNMB-101PN</basicUdiDi>
    <tradeName>Micro-Albumin Qualitative Rapid Test</tradeName>
    <deviceName>Micro-Albumin Qualitative Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VNMB-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:41.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAU-A06aEY</udiDi>
    <basicUdiDi>B-MAU-A06aEY</basicUdiDi>
    <tradeName>MAU Test Kit FIA</tradeName>
    <deviceName>MAU Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAU-A06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:20.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAU-A02aEL</udiDi>
    <basicUdiDi>B-MAU-A02aEL</basicUdiDi>
    <tradeName>MAU Rapid Test</tradeName>
    <deviceName>MAU Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAU-A02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:19.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GIHSA-103aHG3T</udiDi>
    <basicUdiDi>B-GIHSA-103aHG3T</basicUdiDi>
    <tradeName>One Step Microalbumin Test Midstream (Urine)</tradeName>
    <deviceName>One Step Microalbumin Test Midstream (Urine)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHSA-103a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:39.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GIHSA-103a4D</udiDi>
    <basicUdiDi>B-GIHSA-103a4D</basicUdiDi>
    <tradeName>One Step Microalbumin Test Cassette (Urine)</tradeName>
    <deviceName>One Step Microalbumin Test Midstream (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHSA-103a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:38.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GIHSA-102aHG3L</udiDi>
    <basicUdiDi>B-GIHSA-102aHG3L</basicUdiDi>
    <tradeName>One Step Microalbumin Test Cassette (Urine)</tradeName>
    <deviceName>One Step Microalbumin Test Cassette (Urine)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHSA-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:35.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GIHSA-102a4A</udiDi>
    <basicUdiDi>B-GIHSA-102a4A</basicUdiDi>
    <tradeName>One Step Microalbumin Test Cassette (Urine)</tradeName>
    <deviceName>One Step Microalbumin Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHSA-102a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:34.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GIHSA-101aHG3D</udiDi>
    <basicUdiDi>B-GIHSA-101aHG3D</basicUdiDi>
    <tradeName>One Step Microalbumin Test Strip (Urine)</tradeName>
    <deviceName>One Step Microalbumin Test Strip (Urine)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHSA-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:33.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GIHSA-101a47</udiDi>
    <basicUdiDi>B-GIHSA-101a47</basicUdiDi>
    <tradeName>One Step Microalbumin Test Strip (Urine)</tradeName>
    <deviceName>One Step Microalbumin Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHSA-101a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:31.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4101303E5</udiDi>
    <basicUdiDi>B-EIM4101303E5</basicUdiDi>
    <tradeName>D-EIM4101303E5</tradeName>
    <deviceName>Urinary Microalbumin (mAlb) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4101303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:28.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4101302E3</udiDi>
    <basicUdiDi>B-EIM4101302E3</basicUdiDi>
    <tradeName>D-EIM4101302E3</tradeName>
    <deviceName>Urinary Microalbumin (mAlb) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4101302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:28.004Z</lastUpdated>
  </row>
</eudamedExport>