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<eudamedExport entity="devices">
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    <udiDi>00630414961057</udiDi>
    <basicUdiDi>0405686901363VH</basicUdiDi>
    <tradeName>IMMULITE 2000AlaTOP Allergy Screen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_AlaTOP</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380878</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:37.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-LBL417A</udiDi>
    <basicUdiDi>B-ILE-LBL417A</basicUdiDi>
    <tradeName>ILE-LBL417A</tradeName>
    <deviceName>LINEBLOT IGE US9</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:37.335Z</lastUpdated>
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  <row>
    <udiDi>D-ILE-LBL4078</udiDi>
    <basicUdiDi>B-ILE-LBL4078</basicUdiDi>
    <tradeName>D-ILE-LBL4078</tradeName>
    <deviceName>LINEBLOT IGE US8</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:22.116Z</lastUpdated>
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    <udiDi>D-ILE-LBL397P</udiDi>
    <basicUdiDi>B-ILE-LBL397P</basicUdiDi>
    <tradeName>D-ILE-LBL397P</tradeName>
    <deviceName>LINEBLOT IGE US7</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL39</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:20.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-LBL387M</udiDi>
    <basicUdiDi>B-ILE-LBL387M</basicUdiDi>
    <tradeName>D-ILE-LBL387M</tradeName>
    <deviceName>LINEBLOT IGE US6</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL38</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:19.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030585</udiDi>
    <basicUdiDi>B-08684595030585</basicUdiDi>
    <tradeName>RapidFor™ Total IgE Rapid Test Kit</tradeName>
    <deviceName>Total IgE Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:14:26.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491761287</udiDi>
    <basicUdiDi>B-06975491761287</basicUdiDi>
    <tradeName>06975491761287</tradeName>
    <deviceName>Dust Mite Component Allergen specific IgE Multiplex-antibodies Detection Kit (Microarray chip )</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:15.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260153751266</udiDi>
    <basicUdiDi>B-04260153751266</basicUdiDi>
    <tradeName>immunoLINE IgE Nutritional KW1</tradeName>
    <deviceName>immunoLINE IgE Nutritional KW1</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:50:51.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251342603756</udiDi>
    <basicUdiDi>B-04251342603756</basicUdiDi>
    <tradeName>Panel 30 RESP EGY-A</tradeName>
    <deviceName>AllergyScreen®/AlleisaScreen®</deviceName>
    <manufacturerName>MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik</manufacturerName>
    <manufacturerSrn>DE-MF-000004992</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:43.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251342603039</udiDi>
    <basicUdiDi>B-04251342603039</basicUdiDi>
    <tradeName>Panel 30 Mix B</tradeName>
    <deviceName>AllergyScreen®/AlleisaScreen®</deviceName>
    <manufacturerName>MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik</manufacturerName>
    <manufacturerSrn>DE-MF-000004992</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:41.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251342601257</udiDi>
    <basicUdiDi>B-04251342601257</basicUdiDi>
    <tradeName>Panel 30 Resp A</tradeName>
    <deviceName>AllergyScreen®/AlleisaScreen®</deviceName>
    <manufacturerName>MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik</manufacturerName>
    <manufacturerSrn>DE-MF-000004992</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:39.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>48058945152797</udiDi>
    <basicUdiDi>8058945151N3500X33</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Mixes - Allergia SPA Miscele</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3500 GX1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:26.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>48058945152438</udiDi>
    <basicUdiDi>8058945151N3255C2C</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Drugs - Allergia SPA Farmaci</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3255 C1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:25.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>48058945152223</udiDi>
    <basicUdiDi>8058945151N3100EYW</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Epithelia - Allergia SPA Epiteli</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 E1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:24.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>48058945152094</udiDi>
    <basicUdiDi>8058945151N3100IZ6</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Insects - Allergia SPA Insetti</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 I1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:20.499Z</lastUpdated>
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    <udiDi>48058945151899</udiDi>
    <basicUdiDi>8058945151N3100MZE</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Molds - Allergia SPA Muffe</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 M1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:19.703Z</lastUpdated>
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    <udiDi>48058945151851</udiDi>
    <basicUdiDi>8058945151N3100PZL</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Parasites - Allergia SPA Parassiti</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 P1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:18.901Z</lastUpdated>
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    <udiDi>48058945150953</udiDi>
    <basicUdiDi>8058945151N3100FYY</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Foods - Allergia SPA Alimenti</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 F1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:18.105Z</lastUpdated>
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    <udiDi>48058945150700</udiDi>
    <basicUdiDi>8058945151N3100TZU</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Trees - Allergia SPA Alberi</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 T1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:14.091Z</lastUpdated>
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    <udiDi>48058945150595</udiDi>
    <basicUdiDi>8058945151N3100KZA</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Occupationals - Allergia SPA Professionali</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3100 K74</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:13.295Z</lastUpdated>
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