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<eudamedExport entity="devices">
  <row>
    <udiDi>00842768006692</udiDi>
    <basicUdiDi>0405686900884WB</basicUdiDi>
    <tradeName>N Latex IgG4</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_IGG4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:07.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768006166</udiDi>
    <basicUdiDi>0405686900917VZ</basicUdiDi>
    <tradeName>Dimension Vista Immunoglobulin A Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_C_KIT_V_IGA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:18:50.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768009815</udiDi>
    <basicUdiDi>0405686900180UY</basicUdiDi>
    <tradeName>N Antiserum to Human IgM</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_AS_IGM</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:11.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768009778</udiDi>
    <basicUdiDi>0405686900179VF</basicUdiDi>
    <tradeName>N Antiserum to Human IgG</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_AS_IGG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:08.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768009730</udiDi>
    <basicUdiDi>0405686900178VD</basicUdiDi>
    <tradeName>N Antiserum to Human IgA</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_AS_IGA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446292</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:06.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414954134</udiDi>
    <basicUdiDi>0405686900221UM</basicUdiDi>
    <tradeName>IMMULITE 2000 OM-MA Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_OM-MA_Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387067</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:50.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414953496</udiDi>
    <basicUdiDi>0405686900218UY</basicUdiDi>
    <tradeName>IMMULITE 2000 3g Allergy Specific IgE Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_3g Allergy Spfc IgE Sample Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10283033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:49.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414312446</udiDi>
    <basicUdiDi>0405686900184V8</basicUdiDi>
    <tradeName>N FLC Supplementary Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_A_PROF_REAG_N_FLC_Sup</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873769</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:25.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PartNummber447460R4</udiDi>
    <basicUdiDi>B-PartNummber447460R4</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:19.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IgM601LH</udiDi>
    <basicUdiDi>B-IgM601LH</basicUdiDi>
    <tradeName>Immunoglobulin M Reagent Kit</tradeName>
    <deviceName>Immunoglobulin M 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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IgM6011Y, IgM6012Y, IgM6013Y, IgM6014Y, IgM6015Y, IgM6011N, IgM6012N, IgM6013N, IgM6014N, IgM6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:46.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IgG601K7</udiDi>
    <basicUdiDi>B-IgG601K7</basicUdiDi>
    <tradeName>Immunoglobulin G Reagent Kit</tradeName>
    <deviceName>Immunoglobulin G 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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IgG6011Y, IgG6012Y, IgG6013Y, IgG6014Y, IgG6015Y, IgG6011N, IgG6012N, IgG6013N, IgG6014N, IgG6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:46.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IgA601HV</udiDi>
    <basicUdiDi>B-IgA601HV</basicUdiDi>
    <tradeName>Immunoglobulin A Reagent Kit</tradeName>
    <deviceName>Immunoglobulin A 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IgA6011Y, IgA6012Y, IgA6013Y, IgA6014Y, IgA6015Y, IgA6011N, IgA6012N, IgA6013N, IgA6014N, IgA6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:41.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0223NC</udiDi>
    <basicUdiDi>B-I0223NC</basicUdiDi>
    <tradeName>Lambda Light Chain</tradeName>
    <deviceName>Lambda Light Chain</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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0223</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:48.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0222NA</udiDi>
    <basicUdiDi>B-I0222NA</basicUdiDi>
    <tradeName>Kappa Light Chain</tradeName>
    <deviceName>Kappa Light Chain</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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:47.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0208NG</udiDi>
    <basicUdiDi>B-I0208NG</basicUdiDi>
    <tradeName>Immunoglobulin M (IgM)</tradeName>
    <deviceName>Immunoglobulin M (IgM)</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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0208</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:28.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0207NE</udiDi>
    <basicUdiDi>B-I0207NE</basicUdiDi>
    <tradeName>Immunoglobulin G (IgG)</tradeName>
    <deviceName>Immunoglobulin G (IgG)</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0207</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:26.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0206NC</udiDi>
    <basicUdiDi>B-I0206NC</basicUdiDi>
    <tradeName>Immunoglobulin A (IgA)</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0206</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:22.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05063087R</udiDi>
    <basicUdiDi>B-ECH05063087R</basicUdiDi>
    <tradeName>D-ECH05063087R</tradeName>
    <deviceName>Immunoglobulin M (IgM)</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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0506308</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:24.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05063077P</udiDi>
    <basicUdiDi>B-ECH05063077P</basicUdiDi>
    <tradeName>D-ECH05063077P</tradeName>
    <deviceName>Immunoglobulin A (IgA)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0506307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:23.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05063067M</udiDi>
    <basicUdiDi>B-ECH05063067M</basicUdiDi>
    <tradeName>D-ECH05063067M</tradeName>
    <deviceName>Immunoglobulin G (IgG)</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0506306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:22.321Z</lastUpdated>
  </row>
</eudamedExport>