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    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card: Single strip cards, no lines</deviceName>
    <manufacturerName>Advance Dx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044758</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMT01.1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:58.688Z</lastUpdated>
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    <udiDi>00860013988050</udiDi>
    <basicUdiDi>08600139880BUDI0008GB</basicUdiDi>
    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card: (5-100 Packs) 500 single strip cards and 500 foil</deviceName>
    <manufacturerName>Advance Dx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044758</manufacturerSrn>
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    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WTSSNG500</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:56.285Z</lastUpdated>
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    <udiDi>00860013988043</udiDi>
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    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card100 single strip cards and 100 foil</deviceName>
    <manufacturerName>Advance Dx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044758</manufacturerSrn>
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    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
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    <reference>WTSSNG100</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:55.508Z</lastUpdated>
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    <udiDi>00860013988036</udiDi>
    <basicUdiDi>08600139880BUDI0006G7</basicUdiDi>
    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card (5-100 Packs) 500 Double strip cards and 500 foil-Lifeline</deviceName>
    <manufacturerName>Advance Dx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044758</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LLS200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:53.898Z</lastUpdated>
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    <udiDi>00860013988029</udiDi>
    <basicUdiDi>08600139880BUDI0005G5</basicUdiDi>
    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card (5-100 Packs) 500 Single strip cards and 500 foil-Lifeline</deviceName>
    <manufacturerName>Advance Dx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044758</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WTS500</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:51.483Z</lastUpdated>
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    <udiDi>00860013988005</udiDi>
    <basicUdiDi>08600139880BUDI0003FZ</basicUdiDi>
    <tradeName>"Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx 100 Blood Collection Card</deviceName>
    <manufacturerName>Advance Dx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044758</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMT01</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:49.886Z</lastUpdated>
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    <udiDi>00860006973513</udiDi>
    <basicUdiDi>0860006973517L</basicUdiDi>
    <tradeName>AAV5 NAb Test Specimen Collection Kit</tradeName>
    <deviceName>AAV5 NAb Test Specimen Collection Kit</deviceName>
    <manufacturerName>Precision for Medicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007346</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTKIT80001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:51:30.253Z</lastUpdated>
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    <udiDi>00851802007113</udiDi>
    <basicUdiDi>08518020070L9</basicUdiDi>
    <tradeName>00851802007113</tradeName>
    <deviceName>SELPHYL PRP Tube</deviceName>
    <manufacturerName>Factor Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041642</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0363</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:35:10.864Z</lastUpdated>
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    <udiDi>40844509002251</udiDi>
    <basicUdiDi>08445090CFBCTCEBX</basicUdiDi>
    <tradeName>Streck Cell-Free DNA BCT CE</tradeName>
    <deviceName>Cell-Free DNA BCT CE</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:26:55.797Z</lastUpdated>
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    <udiDi>20812589020010</udiDi>
    <basicUdiDi>081258902GR22624</basicUdiDi>
    <tradeName>Revvity 226 Sample Collection Device</tradeName>
    <deviceName>Revvity 226 Sample Collection Device</deviceName>
    <manufacturerName>Revvity Health Sciences, Inc . - SC</manufacturerName>
    <manufacturerSrn>US-MF-000022419</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR226XXXX</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:49.770Z</lastUpdated>
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    <udiDi>50382903643160</udiDi>
    <basicUdiDi>038290UJSKOQNYN5</basicUdiDi>
    <tradeName>Preset</tradeName>
    <deviceName>BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010103</emdnCode>
    <emdnDescription>BLOOD GAS SAMPLES COLLECTION, SYRINGES WITHOUT NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>364316</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:51:02.307Z</lastUpdated>
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    <udiDi>30382903610175</udiDi>
    <basicUdiDi>038290OBCGTWMK7H</basicUdiDi>
    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® K3E Aprotinin Blood Collection Tube</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>361017</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:49:24.335Z</lastUpdated>
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    <udiDi>00382903649020</udiDi>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® Luer-Lok™ Access Device</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36490200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:34.438Z</lastUpdated>
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    <udiDi>00382903600632</udiDi>
    <basicUdiDi>038290OKYSFZWGPF</basicUdiDi>
    <tradeName>Vacutainer Barricor</tradeName>
    <deviceName>BD Vacutainer® Barricor™ LH Plasma Blood Collection Tube</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360063</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:31.982Z</lastUpdated>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® CPT™ Cell Preparation Tube</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>362780</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:39:30.244Z</lastUpdated>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® Blood Transfer Device</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36481000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:33:42.278Z</lastUpdated>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® Trace Element Blood Collection Tube</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® ACD Blood Collection Tube</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360085</reference>
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    <lastUpdated>2026-07-15T20:33:41.337Z</lastUpdated>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® Fluoride Blood Collection Tubes</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360068</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:33:35.316Z</lastUpdated>
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    <tradeName>Vacutainer</tradeName>
    <deviceName>BD Vacutainer® Citrate Blood Collection Tubes</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000019182</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360066</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:33:34.513Z</lastUpdated>
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