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    <basicUdiDi>B-00816426020108</basicUdiDi>
    <tradeName>K-ASSAY IgG</tradeName>
    <deviceName>IgG Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-014</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:04.456Z</lastUpdated>
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    <udiDi>00816426020092</udiDi>
    <basicUdiDi>B-00816426020092</basicUdiDi>
    <tradeName>K-ASSAY IgA</tradeName>
    <deviceName>IgA Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-013</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:27.498Z</lastUpdated>
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    <udiDi>08707696700024</udiDi>
    <basicUdiDi>872076967ZNV4ST</basicUdiDi>
    <tradeName>08707696700024</tradeName>
    <deviceName>Diagnostic Consumable Kit Ziehl Neelsen (ZN) V4</deviceName>
    <manufacturerName>Svizera Europe BV</manufacturerName>
    <manufacturerSrn>NL-MF-000047495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Diagnostic Consumable Kit Ziehl Neelsen (ZN) V4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:52:53.029Z</lastUpdated>
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    <udiDi>08707696700017</udiDi>
    <basicUdiDi>87076967AuramineV4C3</basicUdiDi>
    <tradeName>08707696700017</tradeName>
    <deviceName>Diagnostic Consumable Kit Auramine V4</deviceName>
    <manufacturerName>Svizera Europe BV</manufacturerName>
    <manufacturerSrn>NL-MF-000047495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Auramine V4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:16:47.721Z</lastUpdated>
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    <udiDi>08434477208126</udiDi>
    <basicUdiDi>843447708-IGDCC</basicUdiDi>
    <tradeName>08434477208126</tradeName>
    <deviceName>IgD Immunoglobulins</deviceName>
    <manufacturerName>Trimero Diagnostics SL</manufacturerName>
    <manufacturerSrn>ES-MF-000000563</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010103</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-42650</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:37:57.854Z</lastUpdated>
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    <udiDi>08426950036951</udiDi>
    <basicUdiDi>842695003695173</basicUdiDi>
    <tradeName>IgG</tradeName>
    <deviceName>IgG</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-2269</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:09.755Z</lastUpdated>
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    <udiDi>08426950036944</udiDi>
    <basicUdiDi>842695003694476</basicUdiDi>
    <tradeName>IgA</tradeName>
    <deviceName>IgA</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-2268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:07.358Z</lastUpdated>
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    <udiDi>08426950013006</udiDi>
    <basicUdiDi>842695001300646</basicUdiDi>
    <tradeName>IgM</tradeName>
    <deviceName>IgM</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-2270</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:51.363Z</lastUpdated>
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    <udiDi>08058945155813</udiDi>
    <basicUdiDi>8058945153APL1000MPD</basicUdiDi>
    <tradeName>Evo Autoimmune M</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgM Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgM Specifici</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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3aPL1000M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:16:04.359Z</lastUpdated>
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    <udiDi>08058945155806</udiDi>
    <basicUdiDi>8058945153APL1000GNZ</basicUdiDi>
    <tradeName>Evo Autoimmune G</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgG Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgG Specifici</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3aPL1000G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:16:03.510Z</lastUpdated>
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    <udiDi>08058945155790</udiDi>
    <basicUdiDi>8058945153AU1000AA5</basicUdiDi>
    <tradeName>Evo Autoimmune A</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgA Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgA Specifici</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU1000A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:16:02.711Z</lastUpdated>
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    <udiDi>08058945155783</udiDi>
    <basicUdiDi>8058945153AU1000G2FK</basicUdiDi>
    <tradeName>Evo Autoimmune G</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgG Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgG Specifici</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU1000G2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:57.913Z</lastUpdated>
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    <udiDi>08058945155776</udiDi>
    <basicUdiDi>8058945153AU1000G1FH</basicUdiDi>
    <tradeName>Evo Autoimmune G</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgG Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgG Specifici</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU1000G1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:57.107Z</lastUpdated>
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    <udiDi>08058945155745</udiDi>
    <basicUdiDi>8058945151N1000G42L</basicUdiDi>
    <tradeName>Evo Specific G4</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgG4 Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgG4 Specifici</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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N1000G4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:51.506Z</lastUpdated>
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    <udiDi>08058945155738</udiDi>
    <basicUdiDi>8058945151N1000GY5</basicUdiDi>
    <tradeName>Evo Specific G</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgG Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgG Specifici</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N1000G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:50.709Z</lastUpdated>
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    <udiDi>07333066022796</udiDi>
    <basicUdiDi>7333066BUDI0031LR</basicUdiDi>
    <tradeName>ImmunoCAP Specific IgG4 Calibrator Strip</tradeName>
    <deviceName>ImmunoCAP Specific IgG4</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</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>10-9550-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:22.666Z</lastUpdated>
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    <udiDi>07333066022789</udiDi>
    <basicUdiDi>7333066BUDI0067ME</basicUdiDi>
    <tradeName>ImmunoCAP Specific IgG4 Conjugate 50</tradeName>
    <deviceName>ImmunoCAP Specific IgG4</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</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>10-9549-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:21.869Z</lastUpdated>
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    <udiDi>07333066019765</udiDi>
    <basicUdiDi>7333066BUDI0055M7</basicUdiDi>
    <tradeName>ImmunoCAP Specific IgG Conjugate 50</tradeName>
    <deviceName>ImmunoCAP Specific IgG</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-9318-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:01.058Z</lastUpdated>
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    <udiDi>07333066014708</udiDi>
    <basicUdiDi>7333066BUDI0089MQ</basicUdiDi>
    <tradeName>EliA IgM Calibrator Well</tradeName>
    <deviceName>EliA IgM Method reagents</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5527-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:20.900Z</lastUpdated>
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    <basicUdiDi>7333066BUDI0082MA</basicUdiDi>
    <tradeName>EliA IgA Calibrator Well</tradeName>
    <deviceName>EliA IgA Method Reagents</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5516-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:16.096Z</lastUpdated>
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