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    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
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    <reference>R1: 2×40 mL, R2: 1×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:18.017Z</lastUpdated>
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    <tradeName>06937287300315</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:51:47.994Z</lastUpdated>
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    <basicUdiDi>B-06937287300308</basicUdiDi>
    <tradeName>06937287300308</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:51:46.798Z</lastUpdated>
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    <basicUdiDi>5051700LK016.OPT4H</basicUdiDi>
    <tradeName>Optilite® Freelite® Kappa Free Control Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ016.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.487Z</lastUpdated>
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    <udiDi>05051700018838</udiDi>
    <basicUdiDi>5051700LK016.CBXD</basicUdiDi>
    <tradeName>Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ016.CB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.463Z</lastUpdated>
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    <udiDi>05051700018845</udiDi>
    <basicUdiDi>5051700LK018.CBXT</basicUdiDi>
    <tradeName>Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ018.CB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.440Z</lastUpdated>
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    <udiDi>05051700019644</udiDi>
    <basicUdiDi>5051700LK016.OPT4H</basicUdiDi>
    <tradeName>Optilite® Freelite® Kappa Free Kit (x10)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK016.10.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:15.796Z</lastUpdated>
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    <basicUdiDi>5051700LK018.OPT57</basicUdiDi>
    <tradeName>Optilite® Freelite® Lambda Free Kit (x10)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK018.10.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:15.770Z</lastUpdated>
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    <udiDi>05051700020206</udiDi>
    <basicUdiDi>5051700LK016.M.OPTJR</basicUdiDi>
    <tradeName>Optilite® Freelite Mx™ Kappa Free Control Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ016.M.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:15.630Z</lastUpdated>
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    <udiDi>05051700020213</udiDi>
    <basicUdiDi>5051700LK018.M.OPTKT</basicUdiDi>
    <tradeName>Optilite® Freelite Mx™ Lambda Free Control Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ018.M.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:15.613Z</lastUpdated>
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    <udiDi>05051700020701</udiDi>
    <basicUdiDi>5051700MSR801.MJ4</basicUdiDi>
    <tradeName>Immunoglobulin Isotypes (GAM) for the EXENT® Analyser</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSR801.M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:15.337Z</lastUpdated>
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    <udiDi>00842768012693</udiDi>
    <basicUdiDi>0405686900947WA</basicUdiDi>
    <tradeName>N Antiserum to Human Ig/L‑chain, λ‑type</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>10446596</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T03:48:35.653Z</lastUpdated>
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    <udiDi>00842768031434</udiDi>
    <basicUdiDi>0405686900184V8</basicUdiDi>
    <tradeName>N FLC Supplementary Reagent</tradeName>
    <deviceName></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>10482439</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T03:48:35.459Z</lastUpdated>
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    <udiDi>00842768012679</udiDi>
    <basicUdiDi>0405686900947WA</basicUdiDi>
    <tradeName>N Antiserum to Human Ig/L‑chain, κ‑type</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>10446594</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:49:42.574Z</lastUpdated>
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