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    <basicUdiDi>5051700MSR801.MJ4</basicUdiDi>
    <tradeName>EXENT® Immunoglobulin Isotypes (GAM) Control Pack</tradeName>
    <deviceName>Immunoglobulin Isotypes (GAM) for the EXENT® Analyser</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSQ801.M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:54.647Z</lastUpdated>
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    <udiDi>05051700019897</udiDi>
    <basicUdiDi>5051700LK018.M.OPTKT</basicUdiDi>
    <tradeName>Optilite® Freelite Mx™ Lambda Free Kit</tradeName>
    <deviceName>Optilite® Freelite Mx™ Lambda Free Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK018.M.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:52.909Z</lastUpdated>
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    <udiDi>05051700019880</udiDi>
    <basicUdiDi>5051700LK016.M.OPTJR</basicUdiDi>
    <tradeName>Optilite® Freelite Mx™ Kappa Free Kit</tradeName>
    <deviceName>Optilite® Freelite Mx™ Kappa Free Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK016.M.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:50.512Z</lastUpdated>
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    <udiDi>05051700018753</udiDi>
    <basicUdiDi>5051700LK018.OPT57</basicUdiDi>
    <tradeName>Optilite® Freelite® Lambda Free Control Pack</tradeName>
    <deviceName>Optilite® Freelite® Lambda Free Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ018.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:41.737Z</lastUpdated>
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  <row>
    <udiDi>05051700017213</udiDi>
    <basicUdiDi>5051700LK016.OPT4H</basicUdiDi>
    <tradeName>Optilite Freelite Kappa Free Kit</tradeName>
    <deviceName>Optilite® Freelite®  Kappa Free kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK016.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:56.829Z</lastUpdated>
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  <row>
    <udiDi>05051700012096</udiDi>
    <basicUdiDi>5051700LK016.CBXD</basicUdiDi>
    <tradeName>Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems</tradeName>
    <deviceName>Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK016.CB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:34.052Z</lastUpdated>
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  <row>
    <udiDi>05051700012102</udiDi>
    <basicUdiDi>5051700LK018.CBXT</basicUdiDi>
    <tradeName>Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems</tradeName>
    <deviceName>Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK018.CB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:31.152Z</lastUpdated>
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    <udiDi>00842768031410</udiDi>
    <basicUdiDi>0405686902230V4</basicUdiDi>
    <tradeName>N Latex FLC kappa</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10482437</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:37.007Z</lastUpdated>
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    <udiDi>00842768031427</udiDi>
    <basicUdiDi>0405686902230V4</basicUdiDi>
    <tradeName>N Latex FLC lamdba</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10482438</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:18:06.006Z</lastUpdated>
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  <row>
    <udiDi>80536177207262Q</udiDi>
    <basicUdiDi>B-80536177207262Q</basicUdiDi>
    <tradeName>Lambda Light Chain Antibody + Cal/Cont</tradeName>
    <deviceName>Lambda Light Chain Antibody + Cal/Cont</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB1150</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:22:09.039Z</lastUpdated>
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  <row>
    <udiDi>80536177207022A</udiDi>
    <basicUdiDi>B-80536177207022A</basicUdiDi>
    <tradeName>Kappa Light Chain Antibody + Cal/Cont</tradeName>
    <deviceName>Kappa Light Chain Antibody + Cal/Cont</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB1140</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:22:00.323Z</lastUpdated>
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  <row>
    <udiDi>06947145551322</udiDi>
    <basicUdiDi>69471455569X4</basicUdiDi>
    <tradeName>Biossays Lambda Light Chain (Immunoturbidimetric)</tradeName>
    <deviceName>Lambda Light Chain (Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130508017S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:29.143Z</lastUpdated>
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  <row>
    <udiDi>06947145551087</udiDi>
    <basicUdiDi>69471455568X2</basicUdiDi>
    <tradeName>Biossays Kappa Light Chain (Immunoturbidimetric)</tradeName>
    <deviceName>Kappa Light Chain (Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130508016S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:27.539Z</lastUpdated>
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  <row>
    <udiDi>00630414312439</udiDi>
    <basicUdiDi>0405686902230V4</basicUdiDi>
    <tradeName>N Latex FLC lambda</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:54.104Z</lastUpdated>
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    <udiDi>00630414312446</udiDi>
    <basicUdiDi>0405686900184V8</basicUdiDi>
    <tradeName>N FLC Supplementary Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_A_PROF_REAG_N_FLC_Sup</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873769</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:25.170Z</lastUpdated>
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    <udiDi>D-I0223NC</udiDi>
    <basicUdiDi>B-I0223NC</basicUdiDi>
    <tradeName>Lambda Light Chain</tradeName>
    <deviceName>Lambda Light Chain</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0223</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:48.208Z</lastUpdated>
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    <udiDi>D-I0222NA</udiDi>
    <basicUdiDi>B-I0222NA</basicUdiDi>
    <tradeName>Kappa Light Chain</tradeName>
    <deviceName>Kappa Light Chain</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:47.111Z</lastUpdated>
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    <udiDi>D-446470QA</udiDi>
    <basicUdiDi>B-446470QA</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>446470</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:06.861Z</lastUpdated>
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    <udiDi>D-446440PZ</udiDi>
    <basicUdiDi>B-446440PZ</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>446440</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:01.277Z</lastUpdated>
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    <udiDi>D-152H50TSC4F</udiDi>
    <basicUdiDi>B-152H50TSC4F</basicUdiDi>
    <tradeName>Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:08.265Z</lastUpdated>
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