<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646ABP002D2MF</udiDi>
    <basicUdiDi>B-697424646ABP002D2MF</basicUdiDi>
    <tradeName>Amyloid β-protein(Aβ) Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Amyloid β-protein(Aβ) Rapid Test (Serum/Plasma)</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>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP-3011/ABP-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:59.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ABP001CYPK</udiDi>
    <basicUdiDi>B-697424646ABP001CYPK</basicUdiDi>
    <tradeName>Amyloid β-protein(Aβ) Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Amyloid β-protein(Aβ) Rapid Test (Whole Blood/Serum/Plasma)</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>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP-4011/ABP-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:59.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ABP000CWPA</udiDi>
    <basicUdiDi>B-697424646ABP000CWPA</basicUdiDi>
    <tradeName>Amyloid β-protein (Aβ) Rapid Test</tradeName>
    <deviceName>Amyloid β-protein (Aβ) Rapid Test</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP-4011/ABP-3011/ABP-4012/ABP-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:54.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69384449UALBZN</udiDi>
    <basicUdiDi>B-69384449UALBZN</basicUdiDi>
    <tradeName>D-69384449UALBZN</tradeName>
    <deviceName>Urine Microalbumin (MAU) Test</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-UALB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:51:43.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990721U4</udiDi>
    <basicUdiDi>B-6430030990721U4</basicUdiDi>
    <tradeName>Actim® Calprotectin</tradeName>
    <deviceName>Actim® Calprotectin</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35034BU</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:12.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990653UC</udiDi>
    <basicUdiDi>B-6430030990653UC</basicUdiDi>
    <tradeName>Actim® Calprotectin</tradeName>
    <deviceName>Actim® Calprotectin</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35032ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:06.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M15C2Z6</udiDi>
    <basicUdiDi>B-5M15C2Z6</basicUdiDi>
    <tradeName>Cystatin C Test (FIA)</tradeName>
    <deviceName>Cystatin C 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>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5M15C2-25-EU, 5M15C2-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:04.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-431006N-10VG</udiDi>
    <basicUdiDi>B-nvm-431006N-10VG</basicUdiDi>
    <tradeName>NADAL®PROM Amniotic fluid Test</tradeName>
    <deviceName>PROM Amniotic fluid 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>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431006N-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:24.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRF-F233Z</udiDi>
    <basicUdiDi>B-TRF-F233Z</basicUdiDi>
    <tradeName>D-TRF-F233Z</tradeName>
    <deviceName>Transferrin Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:00:02.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0240DB</udiDi>
    <basicUdiDi>B-ST0240DB</basicUdiDi>
    <tradeName>Cystatin C (GFR) test kit  (32 tests)</tradeName>
    <deviceName>Cystatin C (GFR) test kit  (32 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0240</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:34:35.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0141D8</udiDi>
    <basicUdiDi>B-ST0141D8</basicUdiDi>
    <tradeName>Lipoprotein (a) test kit (16 tests)</tradeName>
    <deviceName>Lipoprotein (a) test kit (16 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0141</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:52.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NormalFerritinVP</udiDi>
    <basicUdiDi>B-NormalFerritinVP</basicUdiDi>
    <tradeName>D-NormalFerritinVP</tradeName>
    <deviceName>Normal Ferritin</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:08:27.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MT-F42001UK</udiDi>
    <basicUdiDi>B-MT-F42001UK</basicUdiDi>
    <tradeName>D-MT-F42001UK</tradeName>
    <deviceName>Transferrin and Fecal Occult Blood Combo Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:53.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HighFerritinWW</udiDi>
    <basicUdiDi>B-HighFerritinWW</basicUdiDi>
    <tradeName>D-HighFerritinWW</tradeName>
    <deviceName>High Level Ferritin</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:00:20.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD130X7</udiDi>
    <basicUdiDi>B-GKPD130X7</basicUdiDi>
    <tradeName>Calprotectin / Lactoferrin Rapid Test Kit (Intestinal Inflammation)</tradeName>
    <deviceName>Calprotectin / Lactoferrin Rapid Test Kit (Intestinal Inflammation)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:51.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180729001NM</udiDi>
    <basicUdiDi>B-CNM0000180729001NM</basicUdiDi>
    <tradeName>D-CNM0000180729001NM</tradeName>
    <deviceName>Fecal Occult Blood Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001C 9001S</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:30.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610559</udiDi>
    <basicUdiDi>B-86979834610559</basicUdiDi>
    <tradeName>CRP Test Kit (Serum/plasma/whole blood)</tradeName>
    <deviceName>CRP Test Kit (Serum/plasma/whole blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRP0026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:23:04.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779049Y7HN</udiDi>
    <basicUdiDi>B-84295779049Y7HN</basicUdiDi>
    <tradeName>Simple Calprotectina</tradeName>
    <deviceName>Simple Calprotectina</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.049.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:03.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8429577904912DP4G</udiDi>
    <basicUdiDi>B-8429577904912DP4G</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO CALPROTECTINA  || DRY CALPROTECTIN POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO CALPROTECTINA  - DRY CALPROTECTIN POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.049.XXX.12.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:01.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942144178</udiDi>
    <basicUdiDi>B-84365942144178</basicUdiDi>
    <tradeName>biotical Calprotectin + Lactoferrin Card (+PC +NC)</tradeName>
    <deviceName>biotical Calprotectin + Lactoferrin Card (+PC +NC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25CLCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:30.228Z</lastUpdated>
  </row>
</eudamedExport>