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    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-17T01:30:47.833Z</lastUpdated>
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    <udiDi>D-7184BM</udiDi>
    <basicUdiDi>B-7184BM</basicUdiDi>
    <tradeName>Bioeurope 4 Food Intolerance Test (ref:7184)</tradeName>
    <deviceName>Bioeurope 4 Food Intolerance Test (ref:7184)</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
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    <lastUpdated>2026-07-17T01:30:36.636Z</lastUpdated>
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    <udiDi>D-7182BH</udiDi>
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    <tradeName>Bioeurope 14 Food Intolerance Test (ref:7182)</tradeName>
    <deviceName>Bioeurope 14 Food Intolerance Test (ref:7182)</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
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    <lastUpdated>2026-07-17T01:30:32.589Z</lastUpdated>
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    <udiDi>D-7181BF</udiDi>
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    <deviceName>Bioeurope 7 Food Intolerance Test (ref:7181)</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
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    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:29.980Z</lastUpdated>
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    <udiDi>D-7180BD</udiDi>
    <basicUdiDi>B-7180BD</basicUdiDi>
    <tradeName>Bioeurope 90 Food Intolernace Test (ref:7180)</tradeName>
    <deviceName>Bioeurope 90 Food Intolerance Test (ref:7180)</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:28.797Z</lastUpdated>
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    <udiDi>+ENTIDNOV10204</udiDi>
    <basicUdiDi>B-+ENTIDNOV10204</basicUdiDi>
    <tradeName>+ENTIDNOV10204</tradeName>
    <deviceName>IgE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNOV102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:05.098Z</lastUpdated>
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    <udiDi>04050598012509</udiDi>
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    <tradeName>Histamin Eliminierungs-Ratio (HERO) ELISA</tradeName>
    <deviceName>IDK® DAO ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HISTAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y8215</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:30:14.194Z</lastUpdated>
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    <udiDi>00630414636511</udiDi>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
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    <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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    <udiDi>00630414636535</udiDi>
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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>
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    <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>
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    <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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    <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>
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    <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>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11643681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:07.757Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Allergen-Specific  IgG4</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Allergen-Specific IgG4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380879</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:55.130Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Allergy Specific IgG</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380880</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:54.429Z</lastUpdated>
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    <udiDi>00630414966083</udiDi>
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    <tradeName>IMMULITE 2000 Total IgE</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Total IgE</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380873</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:48.724Z</lastUpdated>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380878</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:37.416Z</lastUpdated>
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