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    <tradeName>Seronorm® Human</tradeName>
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    <manufacturerName>SERO AS</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-11T07:10:24.216Z</lastUpdated>
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    <tradeName>RNA Medical® Full Range CO-Oximeter Control</tradeName>
    <deviceName>RNA Medical® Full Range CO-Oximeter Control -multi level</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
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    <tradeName>RNA Medical® Full Range CO-Oximeter Control -level 1</tradeName>
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    <manufacturerName>Bionostics</manufacturerName>
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    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Multi</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
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    <lastUpdated>2026-07-11T01:41:59.611Z</lastUpdated>
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    <tradeName>RNA Medical® Full Range CO-Oximeter Control -level 3</tradeName>
    <deviceName>RNA Medical QC 253 Full Range CO-Oximeter Control-level 3</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <emdnCode>W0101050101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:58.760Z</lastUpdated>
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    <tradeName>RNA Medical QC 253 Full Range CO-Oximeter Control-level 2</tradeName>
    <deviceName>RNA Medical QC 253 Full Range CO-Oximeter Control-level 2</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 3</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 3</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
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    <lastUpdated>2026-07-11T01:41:41.091Z</lastUpdated>
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    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 2</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 2</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
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    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC527-level 2</reference>
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    <lastUpdated>2026-07-11T01:41:40.305Z</lastUpdated>
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    <udiDi>10851290002413</udiDi>
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    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- level 1</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- level 1</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC527-level 1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:39.489Z</lastUpdated>
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    <udiDi>08699015281812</udiDi>
    <basicUdiDi>B-08699015281812</basicUdiDi>
    <tradeName>HDL-LDL KALİBRATÖR (ARCAL LİPİT)</tradeName>
    <deviceName>HDL-LDL CALIBRATOR ( ARCAL LIPID)</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
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    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R95-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:54.098Z</lastUpdated>
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    <udiDi>08681812526289</udiDi>
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    <tradeName>ÇOK BİLEŞENLİ KALİBRATÖR</tradeName>
    <deviceName>MULTICONSTITUENT CALIBRATOR</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>06R56-02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:10.337Z</lastUpdated>
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    <udiDi>D-084360385825824H7</udiDi>
    <basicUdiDi>B-084360385825824H7</basicUdiDi>
    <tradeName>Contro-P, 4 x 5 mL</tradeName>
    <deviceName>Contro-P, 4 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0253</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:01.543Z</lastUpdated>
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    <udiDi>D-084360385815817GX</udiDi>
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    <tradeName>Contro-N, 4 x 5 mL</tradeName>
    <deviceName>Contro-N, 4 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0252</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:56.745Z</lastUpdated>
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    <tradeName>Contro-P, 20 x 5 mL</tradeName>
    <deviceName>Contro-P, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
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    <reference>101-0084</reference>
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    <lastUpdated>2026-07-07T21:29:06.229Z</lastUpdated>
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    <tradeName>Contro-N, 20 x 5 mL</tradeName>
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    <lastUpdated>2026-07-07T21:29:04.625Z</lastUpdated>
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    <deviceName>AMMONIA/ETHANOL/CO2 CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <lastUpdated>2026-07-07T20:41:58.620Z</lastUpdated>
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    <deviceName>AMMONIA/ETHANOL/CO2 CONTROL I/II</deviceName>
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