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    <tradeName>GlucoDr.PRO™ BLE Control Solution</tradeName>
    <deviceName>ABM-514P Control Solution</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>ABM-514P-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:29.343Z</lastUpdated>
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    <udiDi>08806128351305</udiDi>
    <basicUdiDi>88061283AGM514PCHT</basicUdiDi>
    <tradeName>GlucoDr.PRO™ Control Solution</tradeName>
    <deviceName>AGM-514P Control Solution</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-514P-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:08.016Z</lastUpdated>
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    <udiDi>08806128350605</udiDi>
    <basicUdiDi>88061283ABM513SCFA</basicUdiDi>
    <tradeName>GlucoDr.S™ BLE Control Solution</tradeName>
    <deviceName>ABM-513S Control Solution</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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    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABM-513S-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:01.541Z</lastUpdated>
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    <udiDi>08806128350407</udiDi>
    <basicUdiDi>88061283AGM513SCHX</basicUdiDi>
    <tradeName>GlucoDr.S™ Control Solution</tradeName>
    <deviceName>AGM-513S Control Solution</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-513S-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:56.257Z</lastUpdated>
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    <udiDi>08806128342006</udiDi>
    <basicUdiDi>88061283AGM4200CE6</basicUdiDi>
    <tradeName>GlucoDr.One™ Control Solution</tradeName>
    <deviceName>AGM-4200 Control Solution</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-4200-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:48.730Z</lastUpdated>
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    <udiDi>08806128340101</udiDi>
    <basicUdiDi>88061283AGM4000CDQ</basicUdiDi>
    <tradeName>GlucoDr.auto™ A Control Solution</tradeName>
    <deviceName>AGM-4000 Control Solution</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-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:42.328Z</lastUpdated>
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    <udiDi>08806128320004</udiDi>
    <basicUdiDi>88061283AGM2200CDG</basicUdiDi>
    <tradeName>GlucoDr.SuperSensor™ Control Solution</tradeName>
    <deviceName>AGM-2200 Control Solution</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>
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    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2200-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:35.936Z</lastUpdated>
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    <udiDi>08806128310500</udiDi>
    <basicUdiDi>88061283AGM2100CD9</basicUdiDi>
    <tradeName>GlucoDr.™ Control Solution</tradeName>
    <deviceName>AGM-2100 Control Solution</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-2100-C1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:29.569Z</lastUpdated>
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    <udiDi>06975984062044</udiDi>
    <basicUdiDi>6970341680320200101JD</basicUdiDi>
    <tradeName>HbA1c Control Material</tradeName>
    <deviceName>HbA1c Control Material</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320200301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:13:54.606Z</lastUpdated>
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    <udiDi>05055273220377</udiDi>
    <basicUdiDi>50552732BLOOSMC160RD</basicUdiDi>
    <tradeName>URINE LOW OSMOLALITY CONTROL</tradeName>
    <deviceName>URINE LOW OSMOLALITY CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC10650</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:14:06.454Z</lastUpdated>
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    <udiDi>05055273214802</udiDi>
    <basicUdiDi>50552732BLUCN121507N</basicUdiDi>
    <tradeName>CUSTOM LIQUID URINE CONTROL - LEVEL 1</tradeName>
    <deviceName>CUSTOM LIQUID URINE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC5170</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:27.362Z</lastUpdated>
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    <udiDi>05055273209075</udiDi>
    <basicUdiDi>50552732BSLDLCL099K6</basicUdiDi>
    <tradeName>sLDL CONTROL LEVEL 1 (sLDL CONTROL 1)</tradeName>
    <deviceName>sLDL CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE5013</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:54.459Z</lastUpdated>
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    <basicUdiDi>50552732BLPDCON080GR</basicUdiDi>
    <tradeName>LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)</tradeName>
    <deviceName>LIPID CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE2661</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:20.827Z</lastUpdated>
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    <udiDi>05055273201116</udiDi>
    <basicUdiDi>50552732BCSFCON038D6</basicUdiDi>
    <tradeName>CSF CONTROL - LEVEL 2  (CSF CONTROL 2)</tradeName>
    <deviceName>CSF CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050208</emdnCode>
    <emdnDescription>CSF CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF1500</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:07.220Z</lastUpdated>
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    <udiDi>05055273200096</udiDi>
    <basicUdiDi>50552732BALSCON005DZ</basicUdiDi>
    <tradeName>ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2)</tradeName>
    <deviceName>ALDOLASE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD5001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:06.424Z</lastUpdated>
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    <udiDi>04987503563088</udiDi>
    <basicUdiDi>4987503sdLDLconPA</basicUdiDi>
    <tradeName>small dense LDL-Control Set</tradeName>
    <deviceName>small dense LDL-Control Set</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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08834105190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:32.267Z</lastUpdated>
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    <udiDi>08806128310609</udiDi>
    <basicUdiDi>88061283AGM2100CD9</basicUdiDi>
    <tradeName>trister® 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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2100-C2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:46.178Z</lastUpdated>
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    <basicUdiDi>88061283AGM4000CDQ</basicUdiDi>
    <tradeName>G1 Advance 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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    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-4000-C2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.745Z</lastUpdated>
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    <basicUdiDi>88061283AGM4000CDQ</basicUdiDi>
    <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>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <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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    <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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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-513S-C2-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:26:45.240Z</lastUpdated>
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