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    <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>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385975</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:29.243Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:28.440Z</lastUpdated>
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    <basicUdiDi>0405686900462VD</basicUdiDi>
    <tradeName>IMMULITE 2000 Inhalant Panel 3 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Inhalant Panel 3 Spfc Algn</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385970</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:27.650Z</lastUpdated>
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    <udiDi>00630414960524</udiDi>
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    <tradeName>IMMULITE 2000 Cultivated Corn Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Cultivated Corn Spfc Algn</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>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385914</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:26.860Z</lastUpdated>
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    <udiDi>00630414960395</udiDi>
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    <tradeName>IMMULITE 2000 Food Panel 25 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Food Panel 25 Spfc Algn</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>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385884</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:22.834Z</lastUpdated>
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    <udiDi>00630414960388</udiDi>
    <basicUdiDi>0405686900399VX</basicUdiDi>
    <tradeName>IMMULITE 2000 Food Panel 24 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Food Panel 24 Spfc Algn</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 - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385883</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:22.038Z</lastUpdated>
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    <basicUdiDi>0405686900410US</basicUdiDi>
    <tradeName>IMMULITE 2000 Food Panel 73 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Food Panel 73 Spfc Algn</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:21.241Z</lastUpdated>
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    <udiDi>00630414960425</udiDi>
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    <tradeName>IMMULITE 2000 Food Panel 51 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Food Panel 51 Spfc Algn</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>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385895</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:20.559Z</lastUpdated>
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    <udiDi>00630414960364</udiDi>
    <basicUdiDi>0405686900397VT</basicUdiDi>
    <tradeName>IMMULITE 2000 Food Panel 15 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Food Panel 15 Spfc Algn</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>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385880</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:03.570Z</lastUpdated>
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    <udiDi>00630414960074</udiDi>
    <basicUdiDi>0405686900325V2</basicUdiDi>
    <tradeName>IMMULITE 2000 Chick Pea Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Chick Pea Specific Allergen</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>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385790</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:02.761Z</lastUpdated>
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    <udiDi>00630414960029</udiDi>
    <basicUdiDi>0405686900378VP</basicUdiDi>
    <tradeName>IMMULITE 2000 Eggplant Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Eggplant Specific Allergen</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>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385756</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:01.962Z</lastUpdated>
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    <udiDi>00630414959870</udiDi>
    <basicUdiDi>0405686900253V2</basicUdiDi>
    <tradeName>IMMULITE 2000 Animal Panel 72 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Animal Panel 72 Spfc Algn</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>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385683</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:01.162Z</lastUpdated>
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    <udiDi>00630414959863</udiDi>
    <basicUdiDi>0405686900252UY</basicUdiDi>
    <tradeName>IMMULITE 2000 Animal Panel 71 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Animal Panel 71 Spfc Algn</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>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:58.310Z</lastUpdated>
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    <udiDi>00630414959627</udiDi>
    <basicUdiDi>0405686900469VT</basicUdiDi>
    <tradeName>IMMULITE 2000 Insulin Porcine Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Insulin Porcine Spfc Algn</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>
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    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:58.296Z</lastUpdated>
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    <udiDi>00630414959603</udiDi>
    <basicUdiDi>0405686900246V5</basicUdiDi>
    <tradeName>IMMULITE 2000 Amoxicillin Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Amoxicillin Specific Allergen</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>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:55.554Z</lastUpdated>
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    <basicUdiDi>0405686900247V7</basicUdiDi>
    <tradeName>IMMULITE 2000 Ampicillin Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Ampicillin Specific Allergen</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385621</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:54.755Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
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    <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>
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    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Chironomus spp Spfc Algn</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385963</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:31.541Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Grass Panel 5 Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Grass Panel 5 Spfc Algn</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020203</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10635710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:30.768Z</lastUpdated>
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