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    <tradeName>GlucoSmart® Swing2 Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-4000-C3-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.650Z</lastUpdated>
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    <udiDi>08806128351008</udiDi>
    <basicUdiDi>88061283AGM513SCHX</basicUdiDi>
    <tradeName>familyDr.™ Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-513S-C2-S1</reference>
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    <lastUpdated>2026-07-30T22:26:45.240Z</lastUpdated>
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    <udiDi>08806128351107</udiDi>
    <basicUdiDi>88061283ABM513SCFA</basicUdiDi>
    <tradeName>familyDr.™ BLE Control Solution</tradeName>
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    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <udiDi>08806128351800</udiDi>
    <basicUdiDi>88061283AGM513SCHX</basicUdiDi>
    <tradeName>VERI-Q PRO Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-513S-C4-S1</reference>
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    <lastUpdated>2026-07-30T22:26:44.725Z</lastUpdated>
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    <udiDi>08806128351909</udiDi>
    <basicUdiDi>88061283AGM514PCHT</basicUdiDi>
    <tradeName>trister® P Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-514P-C2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:44.620Z</lastUpdated>
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    <udiDi>08806128352005</udiDi>
    <basicUdiDi>88061283ABM514PCF6</basicUdiDi>
    <tradeName>trister® P BLE Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABM-514P-C2-S1</reference>
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    <lastUpdated>2026-07-30T22:26:44.510Z</lastUpdated>
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    <udiDi>03701700826026</udiDi>
    <basicUdiDi>37017008PRTU04JP</basicUdiDi>
    <tradeName>MICROPROTEIN Standard</tradeName>
    <deviceName>MICROPROTEIN Standard</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRTU-4020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:52:20.294Z</lastUpdated>
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    <udiDi>03701700824008</udiDi>
    <basicUdiDi>37017008ISCA049C</basicUdiDi>
    <tradeName>ISE CALIBRATORS</tradeName>
    <deviceName>ISE CALIBRATORS</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISCA-0250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:46.502Z</lastUpdated>
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    <udiDi>03701700823308</udiDi>
    <basicUdiDi>37017008IPRO04DS</basicUdiDi>
    <tradeName>PROTEIN IP CALIBRATOR SET</tradeName>
    <deviceName>PROTEIN IP CALIBRATOR SET</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPRO-0043</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:38.502Z</lastUpdated>
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    <udiDi>03701700821601</udiDi>
    <basicUdiDi>37017008HLCA046J</basicUdiDi>
    <tradeName>HDL LDL CALIBRATOR</tradeName>
    <deviceName>HDL LDL CALIBRATOR</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLCA-0041</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:01.942Z</lastUpdated>
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    <udiDi>03701700819400</udiDi>
    <basicUdiDi>37017008CONT05AY</basicUdiDi>
    <tradeName>ELITROL I</tradeName>
    <deviceName>ELITROL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONT-0060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:43.531Z</lastUpdated>
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    <udiDi>03701700818908</udiDi>
    <basicUdiDi>37017008CKMB056K</basicUdiDi>
    <tradeName>CK-MB CONTROL</tradeName>
    <deviceName>CK-MB CONTROL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CKMB-0900</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:37.137Z</lastUpdated>
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    <udiDi>03701700817802</udiDi>
    <basicUdiDi>37017008CALI043X</basicUdiDi>
    <tradeName>ELICAL 2</tradeName>
    <deviceName>ELICAL 2</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALI-0550</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:30.734Z</lastUpdated>
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    <udiDi>03610230004852</udiDi>
    <basicUdiDi>361023pentra_ferr_calZS</basicUdiDi>
    <tradeName>ABX Pentra Ferritin Cal</tradeName>
    <deviceName>ABX Pentra Ferritin Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01619</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:52.082Z</lastUpdated>
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    <udiDi>03607360047675</udiDi>
    <basicUdiDi>3607364767BUFW</basicUdiDi>
    <tradeName>MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2)</tradeName>
    <deviceName>MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4767</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:35.579Z</lastUpdated>
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    <udiDi>03607360047651</udiDi>
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    <tradeName>daratumumab CONTROL</tradeName>
    <deviceName>daratumumab CONTROL</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4765</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:34.802Z</lastUpdated>
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    <tradeName>isatuximab CONTROL</tradeName>
    <deviceName>isatuximab CONTROL</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>4764</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:30.836Z</lastUpdated>
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    <basicUdiDi>3607364755BUFD</basicUdiDi>
    <tradeName>Hb A1c CAPILLARY CALIBRATORS (2)</tradeName>
    <deviceName>Hb A1c CAPILLARY CALIBRATORS (2)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:29.995Z</lastUpdated>
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    <tradeName>CK-MB Control Serum Level 2</tradeName>
    <deviceName>CK-MB Control Serum Level 2</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODR30036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:17.843Z</lastUpdated>
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    <tradeName>CK-MB Control Serum Level 1</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODR30035</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:16.243Z</lastUpdated>
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