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    <tradeName>IMMULITE 2000 rAra h 9 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_Ara h 9</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643850</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:31.520Z</lastUpdated>
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    <tradeName>IMMULITE 2000 rDer p 23 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_B_REAG_Der p 23</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>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643852</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:30.717Z</lastUpdated>
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    <udiDi>00630414636504</udiDi>
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    <tradeName>IMMULITE 2000 rAra h 8 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_Ara h 8</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643849</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:30.376Z</lastUpdated>
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    <udiDi>00630414636528</udiDi>
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    <tradeName>IMMULITE 2000 rDer p 10 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_B_REAG_Der p 10</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>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643851</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:30.373Z</lastUpdated>
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    <udiDi>00630414636498</udiDi>
    <basicUdiDi>0405686902342VG</basicUdiDi>
    <tradeName>IMMULITE 2000 nAra h 6 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_Ara h 6</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643848</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:12.385Z</lastUpdated>
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    <udiDi>00630414636382</udiDi>
    <basicUdiDi>0405686902337VP</basicUdiDi>
    <tradeName>IMMULITE 2000 nAra h 3 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_Ara h 3</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643847</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:12.371Z</lastUpdated>
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    <udiDi>00630414636375</udiDi>
    <basicUdiDi>0405686902336VM</basicUdiDi>
    <tradeName>IMMULITE 2000 nAra h 1 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_Ara h 1</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643846</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:12.363Z</lastUpdated>
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  <row>
    <udiDi>00630414636368</udiDi>
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    <tradeName>IMMULITE 2000 Tri a 19 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_Tri a 19</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643682</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:07.761Z</lastUpdated>
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    <udiDi>00630414636351</udiDi>
    <basicUdiDi>0405686902335VK</basicUdiDi>
    <tradeName>IMMULITE 2000 rAra h 2 Specific Allergen</tradeName>
    <deviceName>IVDR_27_LLB_DUB-C_C_REAG_rAra h 2</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:07.757Z</lastUpdated>
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    <udiDi>ILR-E02XC</udiDi>
    <basicUdiDi>B-ILR-E02XC</basicUdiDi>
    <tradeName>Specific IgE RIA</tradeName>
    <deviceName>Specific IgE RIA</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>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILR-E02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:34.205Z</lastUpdated>
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  <row>
    <udiDi>ILR-E01XA</udiDi>
    <basicUdiDi>B-ILR-E01XA</basicUdiDi>
    <tradeName>ILR-E01XA</tradeName>
    <deviceName>Tracer IgE</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>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILR-E01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:33.407Z</lastUpdated>
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  <row>
    <udiDi>D-37700277936012B</udiDi>
    <basicUdiDi>B-37700277936012B</basicUdiDi>
    <tradeName>PEO WB IgG</tradeName>
    <deviceName>PEO WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEO-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:33.060Z</lastUpdated>
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  <row>
    <udiDi>D-377002779359539</udiDi>
    <basicUdiDi>B-377002779359539</basicUdiDi>
    <tradeName>PEO WB IgG</tradeName>
    <deviceName>PEO WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEO-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:31.455Z</lastUpdated>
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    <udiDi>D-37700277935883C</udiDi>
    <basicUdiDi>B-37700277935883C</basicUdiDi>
    <tradeName>PEO WB IgG</tradeName>
    <deviceName>PEO WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEO-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:29.059Z</lastUpdated>
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    <udiDi>D-377002779339733</udiDi>
    <basicUdiDi>B-377002779339733</basicUdiDi>
    <tradeName>PEO ICT IgG-IgM</tradeName>
    <deviceName>PEO ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPEO Ab ICT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:01.030Z</lastUpdated>
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    <udiDi>D-37700277933802J</udiDi>
    <basicUdiDi>B-37700277933802J</basicUdiDi>
    <tradeName>PEO ICT IgG-IgM</tradeName>
    <deviceName>PEO ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPEO Ab ICT20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:56.252Z</lastUpdated>
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    <udiDi>111872012053</udiDi>
    <basicUdiDi>B-111872012053</basicUdiDi>
    <tradeName>mediLance</tradeName>
    <deviceName>Allergy Lancet</deviceName>
    <manufacturerName>KERN LIEBERS Schwabmünchen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01F005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:06.472Z</lastUpdated>
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    <udiDi>04262550790022</udiDi>
    <basicUdiDi>B-04262550790022</basicUdiDi>
    <tradeName>FD Anti-WGA IgG Elisa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FROST Diagnostika GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000034832</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-WGA-G-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:56:24.842Z</lastUpdated>
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    <udiDi>04050598010376</udiDi>
    <basicUdiDi>B-04050598010376</basicUdiDi>
    <tradeName>Tryptase ELISA</tradeName>
    <deviceName>Tryptase ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6814</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:56.579Z</lastUpdated>
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    <udiDi>08051513880018</udiDi>
    <basicUdiDi>805151388CYTOTESTD6</basicUdiDi>
    <tradeName>CYTOTEST</tradeName>
    <deviceName>CYTOTEST - CYTOTOXIC TEST</deviceName>
    <manufacturerName>Cytodiagnostic srl</manufacturerName>
    <manufacturerSrn>SM-MF-000045033</manufacturerSrn>
    <authorisedRepresentativeName>Dott. Carmelo Rizzo</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000040805</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5FHCT51</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:00:52.072Z</lastUpdated>
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