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<eudamedExport entity="devices">
  <row>
    <udiDi>00842768014093</udiDi>
    <basicUdiDi>0405686901058V9</basicUdiDi>
    <tradeName>Dimension® ALDL Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_ALDL CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:34.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005206</udiDi>
    <basicUdiDi>0405686901123UT</basicUdiDi>
    <tradeName>Dimension Total Iron Binding Capacity (IBCT) Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_IBCT CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:49.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597218</udiDi>
    <basicUdiDi>0405686900762VU</basicUdiDi>
    <tradeName>Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ALP_2_Cal</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099316</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:39.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597201</udiDi>
    <basicUdiDi>0405686900761VS</basicUdiDi>
    <tradeName>Atellica CH Albumin BCP Calibrator (AlbP CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ALBP_Cal</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:14:37.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005183</udiDi>
    <basicUdiDi>0405686900206UR</basicUdiDi>
    <tradeName>Dimension Prealbumin Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PALB_cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:49.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02469A</udiDi>
    <basicUdiDi>B-IS02469A</basicUdiDi>
    <tradeName>Immunoglobulin E Standard</tradeName>
    <deviceName>Immunoglobulin E Standard</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0246</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:20.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02418Y</udiDi>
    <basicUdiDi>B-IS02418Y</basicUdiDi>
    <tradeName>Antistreptolisin O</tradeName>
    <deviceName>Antistreptolisin O</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0241</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:09.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02295N6</udiDi>
    <basicUdiDi>B-IS02295N6</basicUdiDi>
    <tradeName>Fibrinogen‐ONE Calibrator</tradeName>
    <deviceName>Fibrinogen‐ONE Calibrator</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS02295</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:07.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS022796</udiDi>
    <basicUdiDi>B-IS022796</basicUdiDi>
    <tradeName>Specific Proteins Multicalibrator</tradeName>
    <deviceName>Specific Proteins Multicalibrator</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0227</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:40:40.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02038Q</udiDi>
    <basicUdiDi>B-IS02038Q</basicUdiDi>
    <tradeName>Cystatin C Standard</tradeName>
    <deviceName>Cystatin C Standard</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS0203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:40:38.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS01ULKW9</udiDi>
    <basicUdiDi>B-IS01ULKW9</basicUdiDi>
    <tradeName>ULK (Urine Kappa and Lambda) Calibrator</tradeName>
    <deviceName>ULK (Urine Kappa and Lambda) Calibrator</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS01ULK</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:40:35.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS01274MP</udiDi>
    <basicUdiDi>B-IS01274MP</basicUdiDi>
    <tradeName>Microalbumin Calibrator</tradeName>
    <deviceName>Microalbumin Calibrator</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS01274</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:40:33.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CS02385K2</udiDi>
    <basicUdiDi>B-CS02385K2</basicUdiDi>
    <tradeName>TOTAL HEMOGLOBIN</tradeName>
    <deviceName>TOTAL HEMOGLOBIN</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS02385</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:36.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CALIBRATORE-HDL-LDLND</udiDi>
    <basicUdiDi>B-CALIBRATORE-HDL-LDLND</basicUdiDi>
    <tradeName>CALIBRATORE HDL/LDL</tradeName>
    <deviceName>CALIBRATORE HDL/LDL</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC40-1-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:33.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-87205897082359Z</udiDi>
    <basicUdiDi>B-87205897082359Z</basicUdiDi>
    <tradeName>HbA1c, Frozen Whole Blood</tradeName>
    <deviceName>HbA1c, Frozen Whole Blood, Level Low</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-03.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:26:14.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-87205897082429W</udiDi>
    <basicUdiDi>B-87205897082429W</basicUdiDi>
    <tradeName>HbA1c, Frozen Whole Blood</tradeName>
    <deviceName>HbA1c, Frozen Whole Blood, Level High</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-03.3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:26:13.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897082286</udiDi>
    <basicUdiDi>B-87205897082286</basicUdiDi>
    <tradeName>HbA1c, ingevroren volbloed Level 2</tradeName>
    <deviceName>HbA1c, ingevroren volbloed</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-01.2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:23.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897082118</udiDi>
    <basicUdiDi>B-87205897082118</basicUdiDi>
    <tradeName>HbA1c, ingevroren volbloed Level 1</tradeName>
    <deviceName>HbA1c, ingevroren volbloed</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-01.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:23.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897082040</udiDi>
    <basicUdiDi>B-87205897082040</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level High</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.2 CV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:23.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081982</udiDi>
    <basicUdiDi>B-87205897081982</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level Low</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.1 CV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:22.961Z</lastUpdated>
  </row>
</eudamedExport>