<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6-51AB</udiDi>
    <basicUdiDi>B-6-51AB</basicUdiDi>
    <tradeName>D-6-51AB</tradeName>
    <deviceName>Calcium (Ca) Assay Kit (Arsenazo Ⅲ Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000692, USCA00000693, USCA00000694, USCA00000695"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:13:11.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-46Z</udiDi>
    <basicUdiDi>B-6-46Z</basicUdiDi>
    <tradeName>D-6-46Z</tradeName>
    <deviceName>Calcium Reagent Kit (OCPC Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U85282050M, U85288060M, U85289020M, U85285020M, U85220020M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:13:03.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700802211</udiDi>
    <basicUdiDi>37017008CALA012H</basicUdiDi>
    <tradeName>CALCIUM ARSENAZO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALA-5M30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:58.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700817611</udiDi>
    <basicUdiDi>37017008CALA002F</basicUdiDi>
    <tradeName>CALCIUM ARSENAZO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALA-5220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:54.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700817703</udiDi>
    <basicUdiDi>37017008CALA002F</basicUdiDi>
    <tradeName>CALCIUM ARSENAZO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALA-0600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:54.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700817710</udiDi>
    <basicUdiDi>37017008CALA002F</basicUdiDi>
    <tradeName>CALCIUM ARSENAZO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALA-5600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:54.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034063843092</udiDi>
    <basicUdiDi>B-08034063843092</basicUdiDi>
    <tradeName>CALCIUM</tradeName>
    <deviceName>CALCUM</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL14-400S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:27:05.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034063843085</udiDi>
    <basicUdiDi>B-08034063843085</basicUdiDi>
    <tradeName>CALCIUM</tradeName>
    <deviceName>CALCIUM (ARSENAZO III</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL14-200S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:27:04.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595672</udiDi>
    <basicUdiDi>0405686901672VZ</basicUdiDi>
    <tradeName>Atellica CH Calcium (Ca)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CA_c</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097595</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:40.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414220697</udiDi>
    <basicUdiDi>0405686900772VX</basicUdiDi>
    <tradeName>Atellica CH Calcium_2 (CA_2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CA_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097644</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:00.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01032515C</udiDi>
    <basicUdiDi>B-ECH01032515C</basicUdiDi>
    <tradeName>D-ECH01032515C</tradeName>
    <deviceName>Calcium (Ca)</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>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0103251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:31.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01012514W</udiDi>
    <basicUdiDi>B-ECH01012514W</basicUdiDi>
    <tradeName>D-ECH01012514W</tradeName>
    <deviceName>Calcium (Ca)</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>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:27.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Calcium2M</udiDi>
    <basicUdiDi>B-Calcium2M</basicUdiDi>
    <tradeName>Calcium</tradeName>
    <deviceName>Calcium</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Cal-Mc-02100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:13:46.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Ca-CPC6016Q</udiDi>
    <basicUdiDi>B-Ca-CPC6016Q</basicUdiDi>
    <tradeName>Calcium Reagent Kit</tradeName>
    <deviceName>Calcium Reagent Kit</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>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ca-CPC6011Y, Ca-CPC6012Y,Ca-CPC6013Y,Ca-CPC6014Y,Ca-CPC6015Y,Ca-CPC6011N,Ca-CPC6012N,Ca-CPC6013N,Ca-CPC6014N,Ca-CPC6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:13:45.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Ca-ARS601A4</udiDi>
    <basicUdiDi>B-Ca-ARS601A4</basicUdiDi>
    <tradeName>Calcium Reagent Kit</tradeName>
    <deviceName>Calcium Reagent Kit</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>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ca-ARS6011Y,Ca-ARS6012Y,Ca-ARS6013Y,Ca-ARS6014Y,Ca-ARS6015Y,Ca-ARS6011N,Ca-ARS6012N,Ca-ARS6013N,Ca-ARS6014N,Ca-ARS6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:13:40.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CALCIO-ARSENAZO-LRRN</udiDi>
    <basicUdiDi>B-CALCIO-ARSENAZO-LRRN</basicUdiDi>
    <tradeName>CALCIO ARSENAZO LR Reattivo liquido</tradeName>
    <deviceName>CALCIO ARSENAZO LR reattivo liquido</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC247-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:28.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0167LR</udiDi>
    <basicUdiDi>B-C0167LR</basicUdiDi>
    <tradeName>Calcium OCP</tradeName>
    <deviceName>Calcium OCP</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0167</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:26.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77939KL</udiDi>
    <basicUdiDi>B-77939KL</basicUdiDi>
    <tradeName>SPOTCHEM D Ca</tradeName>
    <deviceName>SPOTCHEM D Ca</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77939</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:24:34.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77487K6</udiDi>
    <basicUdiDi>B-77487K6</basicUdiDi>
    <tradeName>SPOTCHEM II Calcium</tradeName>
    <deviceName>SPOTCHEM II Calcium</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77487</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:56.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77166JF</udiDi>
    <basicUdiDi>B-77166JF</basicUdiDi>
    <tradeName>SPOTCHEM II Calcium</tradeName>
    <deviceName>SPOTCHEM II Calcium</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77166</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:33.699Z</lastUpdated>
  </row>
</eudamedExport>