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    <tradeName>α1-Microglobulin</tradeName>
    <deviceName>a1-Microglobulin</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08944539190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:30.933Z</lastUpdated>
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    <udiDi>04987481164833</udiDi>
    <basicUdiDi>49874814987481164833V4</basicUdiDi>
    <tradeName>Autokit CH50 Set</tradeName>
    <deviceName>Autokit CH50 Set, CH50 Calibrator Set, Complement Control Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TOTAL COMPLEMENT ACTIVITY (CH50)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993-40601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:49.125Z</lastUpdated>
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    <tradeName>NESCAUTO Cp Auto AA01</tradeName>
    <deviceName>NESCAUTO Cp Auto AA01</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>912682</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>NESCAUTO Cp Auto NS-Prime</tradeName>
    <deviceName>NESCAUTO Cp Auto NS-Prime</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>912681</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:01.937Z</lastUpdated>
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    <udiDi>04719879490664</udiDi>
    <basicUdiDi>471987949E103017J</basicUdiDi>
    <tradeName>DNlite-IVD103</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8103106 (4oC)</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:46:42.406Z</lastUpdated>
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    <udiDi>04719879490053</udiDi>
    <basicUdiDi>471987949E103017J</basicUdiDi>
    <tradeName>DNlite-IVD103</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8103106 (-20oC)</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:39:37.512Z</lastUpdated>
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    <udiDi>04260157630840</udiDi>
    <basicUdiDi>426015763816BAFPKDil0XXNY</basicUdiDi>
    <tradeName>B·R·A·H·M·S AFP KRYPTOR DILUENT</tradeName>
    <deviceName>B·R·A·H·M·S AFP KRYPTOR DILUENT</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081693N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:08.802Z</lastUpdated>
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    <udiDi>03701700823209</udiDi>
    <basicUdiDi>37017008IPAL039J</basicUdiDi>
    <tradeName>PREALBUMIN IP</tradeName>
    <deviceName>PREALBUMIN IP</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPAL-0400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:33.704Z</lastUpdated>
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    <udiDi>03701700823100</udiDi>
    <basicUdiDi>37017008IORO03DD</basicUdiDi>
    <tradeName>OROSOMUCOID IP</tradeName>
    <deviceName>OROSOMUCOID IP</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IORO-0400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:32.914Z</lastUpdated>
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    <udiDi>03701700823001</udiDi>
    <basicUdiDi>37017008IMAL008B</basicUdiDi>
    <tradeName>µALBUMIN IP</tradeName>
    <deviceName>µALBUMIN IP</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMAL-0400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:32.097Z</lastUpdated>
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    <udiDi>03701700822301</udiDi>
    <basicUdiDi>37017008IHAP037E</basicUdiDi>
    <tradeName>HAPTOGLOBIN IP</tradeName>
    <deviceName>HAPTOGLOBIN IP</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHAP-0400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:24.114Z</lastUpdated>
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    <udiDi>03701700807803</udiDi>
    <basicUdiDi>37017008TRF201BR</basicUdiDi>
    <tradeName>TRANSFERRIN</tradeName>
    <deviceName>TRANSFERRIN</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRF2-M230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:00.288Z</lastUpdated>
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    <udiDi>03701700805007</udiDi>
    <basicUdiDi>37017008IMAL018D</basicUdiDi>
    <tradeName>MICROALBUMIN IP</tradeName>
    <deviceName>MICROALBUMIN IP</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMAL-M230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:49:37.324Z</lastUpdated>
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    <udiDi>03607360045886</udiDi>
    <basicUdiDi>3607364588BUFT</basicUdiDi>
    <tradeName>IF SAMPLE DILUENT</tradeName>
    <deviceName>IF SAMPLE DILUENT</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010111</emdnCode>
    <emdnDescription>IMMUNOFIXATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4588</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:23.591Z</lastUpdated>
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    <basicUdiDi>150995901447720LE</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems CER Ceruloplasmin 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010301</emdnCode>
    <emdnDescription>CERULOPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447720</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:35.608Z</lastUpdated>
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    <tradeName>IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010299</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447760</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:34.813Z</lastUpdated>
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    <tradeName>IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447780</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:34.008Z</lastUpdated>
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    <tradeName>IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447790</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:33.222Z</lastUpdated>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:29.210Z</lastUpdated>
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    <tradeName>IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447730</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:28.407Z</lastUpdated>
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