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    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6003</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:07.028Z</lastUpdated>
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    <udiDi>04260605480140</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>Mister Size 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6010</reference>
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    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>Mister Size 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
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    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:06.966Z</lastUpdated>
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    <udiDi>04260605480171</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>Mister Size 64</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:06.931Z</lastUpdated>
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    <udiDi>04260605480188</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>Mister Size 64</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6436</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:06.885Z</lastUpdated>
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    <udiDi>04260605480201</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>Mister Size 69</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6910</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:06.855Z</lastUpdated>
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    <udiDi>04260605480218</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>Mister Size 69</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS6936</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:06.827Z</lastUpdated>
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    <udiDi>00816426021679</udiDi>
    <basicUdiDi>B-00816426021679</basicUdiDi>
    <tradeName>K-ASSAY hsCRP Control</tradeName>
    <deviceName>hsCRP Control</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K180C-2M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:47.785Z</lastUpdated>
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    <udiDi>00816426021617</udiDi>
    <basicUdiDi>B-00816426021617</basicUdiDi>
    <tradeName>K-ASSAY Cystatin C Control</tradeName>
    <deviceName>Cystatin C Control</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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K200C-2M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:46.175Z</lastUpdated>
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    <udiDi>00816426021600</udiDi>
    <basicUdiDi>B-00816426021600</basicUdiDi>
    <tradeName>K-ASSAY Cystatin C Calibrator</tradeName>
    <deviceName>Cystatin C Calibrator</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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-200C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:45.383Z</lastUpdated>
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    <udiDi>00816426021594</udiDi>
    <basicUdiDi>B-00816426021594</basicUdiDi>
    <tradeName>K-ASSAY UIBC</tradeName>
    <deviceName>UIBC 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>W0102070107</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-305</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:43.776Z</lastUpdated>
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    <udiDi>00816426021556</udiDi>
    <basicUdiDi>B-00816426021556</basicUdiDi>
    <tradeName>K-ASSAY CRP Calibrator (Ver.2)</tradeName>
    <deviceName>CRP Calibrator (Ver.2)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-376C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:41.371Z</lastUpdated>
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    <udiDi>00816426021570</udiDi>
    <basicUdiDi>B-00816426021570</basicUdiDi>
    <tradeName>K-ASSAY KL-6 Calibrator (Ver.2)</tradeName>
    <deviceName>KL-6 Calibrator (Ver.2)</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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-351C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:39.771Z</lastUpdated>
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    <udiDi>00816426021563</udiDi>
    <basicUdiDi>B-00816426021563</basicUdiDi>
    <tradeName>K-ASSAY KL-6 (Ver.2)</tradeName>
    <deviceName>KL-6 (Ver.2) 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-350</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:38.972Z</lastUpdated>
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    <udiDi>00816426021549</udiDi>
    <basicUdiDi>B-00816426021549</basicUdiDi>
    <tradeName>K-ASSAY CRP (Ver.2)</tradeName>
    <deviceName>CRP (Ver.2) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-375</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:37.479Z</lastUpdated>
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    <udiDi>00816426021457</udiDi>
    <basicUdiDi>B-00816426021457</basicUdiDi>
    <tradeName>K-ASSAY RF (Ver.2)</tradeName>
    <deviceName>RF (Ver.2) 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-230</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:21.408Z</lastUpdated>
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    <udiDi>00816426021419</udiDi>
    <basicUdiDi>B-00816426021419</basicUdiDi>
    <tradeName>K-ASSAY UIBC Calibrator</tradeName>
    <deviceName>UIBC Calibrator</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>W0102070107</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-302C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:19.707Z</lastUpdated>
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    <udiDi>00816426021365</udiDi>
    <basicUdiDi>B-00816426021365</basicUdiDi>
    <tradeName>K-ASSAY Insulin Control</tradeName>
    <deviceName>Insulin Control</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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K73C-4M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:18.909Z</lastUpdated>
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    <basicUdiDi>B-00816426021303</basicUdiDi>
    <tradeName>K-ASSAY Beta-2 Microglobulin Urine Calibrator</tradeName>
    <deviceName>Beta-2 Microglobulin Urine Calibrator</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-282C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:14.911Z</lastUpdated>
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    <udiDi>00816426021297</udiDi>
    <basicUdiDi>B-00816426021297</basicUdiDi>
    <tradeName>K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator</tradeName>
    <deviceName>Beta-2 Microglobulin Serum/Plasma Calibrator</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-281C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:14.112Z</lastUpdated>
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