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    <tradeName>Precise Path</tradeName>
    <deviceName>Precise Path</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:45:59.683Z</lastUpdated>
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    <basicUdiDi>B-08053172971151</basicUdiDi>
    <tradeName>Precise Norm</tradeName>
    <deviceName>Precise Norm</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
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    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>B-08053172971144</basicUdiDi>
    <tradeName>Precise Norm</tradeName>
    <deviceName>Precise Norm</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
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    <lastUpdated>2026-07-07T16:45:54.893Z</lastUpdated>
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    <udiDi>08053172971069</udiDi>
    <basicUdiDi>B-08053172971069</basicUdiDi>
    <tradeName>Controllo HDL/LDL</tradeName>
    <deviceName>Controllo HDL/LDL - HDL/LDL Control</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:45:54.078Z</lastUpdated>
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    <udiDi>08053172971052</udiDi>
    <basicUdiDi>B-08053172971052</basicUdiDi>
    <tradeName>Calibratore Chimica Clinica</tradeName>
    <deviceName>Calibratore Chimica Clinica/Clinical Chemistry Calibrator</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6002/6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:45:53.484Z</lastUpdated>
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    <udiDi>08053172971045</udiDi>
    <basicUdiDi>B-08053172971045</basicUdiDi>
    <tradeName>Calibratore Chimica Clinica</tradeName>
    <deviceName>Calibratore Chimica Clinica/Clinical Chemistry Calibrator</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6002/12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:45:48.476Z</lastUpdated>
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    <udiDi>08033673124089</udiDi>
    <basicUdiDi>B-08033673124089</basicUdiDi>
    <tradeName>CONTROL FOR BIOGENIC AMINES IN URINE - LEVELS 1 AND 2</tradeName>
    <deviceName>Control for Biogenic Amines in urine - Levels 1 and 2</deviceName>
    <manufacturerName>EUREKA S.R.L. LAB DIVISION</manufacturerName>
    <manufacturerSrn>IT-MF-000034499</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z10559</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:16:42.878Z</lastUpdated>
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    <udiDi>08032937230443</udiDi>
    <basicUdiDi>B-08032937230443</basicUdiDi>
    <tradeName>MulticareIN Triglycerides Control Solution - ITA / ENG</tradeName>
    <deviceName>MulticareIN Triglycerides Control Solution - ITA / ENG</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3830303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:20.996Z</lastUpdated>
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    <udiDi>08032937230436</udiDi>
    <basicUdiDi>B-08032937230436</basicUdiDi>
    <tradeName>MulticareIN Cholesterol Control Solution - ITA / ENG</tradeName>
    <deviceName>MulticareIN Cholesterol Control Solution - ITA / ENG</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3830302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:20.194Z</lastUpdated>
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    <udiDi>07798100046006</udiDi>
    <basicUdiDi>B-07798100046006</basicUdiDi>
    <tradeName>HbA1c Control Turbitest AA</tradeName>
    <deviceName>HbA1c Control Turbitest AA</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1999702</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:12.678Z</lastUpdated>
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    <udiDi>07798100044682</udiDi>
    <basicUdiDi>B-07798100044682</basicUdiDi>
    <tradeName>CK-MB Control 3 niveles</tradeName>
    <deviceName>CK-MB Control 3 niveles</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1271553</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:12.050Z</lastUpdated>
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    <udiDi>07798100043357</udiDi>
    <basicUdiDi>B-07798100043357</basicUdiDi>
    <tradeName>Standatrol S-E 2 niveles</tradeName>
    <deviceName>Standatrol S-E 2 niveles</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1937553</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:04.668Z</lastUpdated>
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    <udiDi>07798100043296</udiDi>
    <basicUdiDi>B-07798100043296</basicUdiDi>
    <tradeName>Calibrador A plus</tradeName>
    <deviceName>Calibrador A plus</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1918005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:58.264Z</lastUpdated>
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    <udiDi>07798100040240</udiDi>
    <basicUdiDi>B-07798100040240</basicUdiDi>
    <tradeName>HbA1c Calibrator Turbitest AA</tradeName>
    <deviceName>HbA1c Calibrator Turbitest AA</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1999880</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:18.207Z</lastUpdated>
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    <udiDi>07640402711178</udiDi>
    <basicUdiDi>B-07640402711178</basicUdiDi>
    <tradeName>FORA Control Solution High</tradeName>
    <deviceName>Blood Glucose Control Solution</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ACS016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:23.946Z</lastUpdated>
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    <udiDi>07640402711161</udiDi>
    <basicUdiDi>B-07640402711161</basicUdiDi>
    <tradeName>FORA Control Solution Low</tradeName>
    <deviceName>Blood Glucose Control Solution</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ACS014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:23.881Z</lastUpdated>
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    <udiDi>07640402710126</udiDi>
    <basicUdiDi>B-07640402710126</basicUdiDi>
    <tradeName>FORA Control Solution Normal</tradeName>
    <deviceName>Blood Glucose Control Solution</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ACS015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:11.770Z</lastUpdated>
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    <udiDi>07640143658299</udiDi>
    <basicUdiDi>B-07640143658299</basicUdiDi>
    <tradeName>FORA Control Solution KB Level 2</tradeName>
    <deviceName>𝝱-Ketone Control Solution</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:54.586Z</lastUpdated>
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    <udiDi>07640143658251</udiDi>
    <basicUdiDi>B-07640143658251</basicUdiDi>
    <tradeName>FORA Control Solution UA Normal</tradeName>
    <deviceName>Uric Acid Control Solution</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:50.575Z</lastUpdated>
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    <udiDi>07640143658220</udiDi>
    <basicUdiDi>B-07640143658220</basicUdiDi>
    <tradeName>FORA Control Solution TCH Normal</tradeName>
    <deviceName>Total Cholesterol Control Solution</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:49.878Z</lastUpdated>
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