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    <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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    <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>
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    <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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    <basicUdiDi>0858092006DDCTZ3</basicUdiDi>
    <tradeName>QBC Capillary Blood Tube, 100 Test Kit</tradeName>
    <deviceName>QBC Capillary Blood Tube</deviceName>
    <manufacturerName>Drucker Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000031517</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424241</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:42:45.688Z</lastUpdated>
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    <udiDi>00858092006390</udiDi>
    <basicUdiDi>0858092006DDVT2X</basicUdiDi>
    <tradeName>QBC Venous Blood Tube, 100 Test Kit</tradeName>
    <deviceName>QBC Venous Blood Tube</deviceName>
    <manufacturerName>Drucker Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000031517</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424240</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:42:44.899Z</lastUpdated>
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    <udiDi>00858092006383</udiDi>
    <basicUdiDi>0858092006DDATYV</basicUdiDi>
    <tradeName>QBC AccuTube 100 Test Kit</tradeName>
    <deviceName>QBC AccuTube</deviceName>
    <manufacturerName>Drucker Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000031517</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423406</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:42:44.095Z</lastUpdated>
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    <udiDi>00858092006291</udiDi>
    <basicUdiDi>0858092006DDST2N</basicUdiDi>
    <tradeName>QBC STAR Tube, 100 Test Kit</tradeName>
    <deviceName>QBC STAR Tube</deviceName>
    <manufacturerName>Drucker Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000031517</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>429625</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:42:43.293Z</lastUpdated>
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    <udiDi>10850045030008</udiDi>
    <basicUdiDi>0850045030MXCT-2500L5</basicUdiDi>
    <tradeName>MagCTL Collection Tube (2500 tubes)</tradeName>
    <deviceName>MagCTL Collection Tube (2500 tubes)</deviceName>
    <manufacturerName>MagBio Genomics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038221</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXCT-2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:14.971Z</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>00850059420119</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>30 Microliters MICROSAFE, 2000 tubes</tradeName>
    <deviceName>MICROSAFE</deviceName>
    <manufacturerName>Drummond Scientific Company</manufacturerName>
    <manufacturerSrn>US-MF-000039345</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:30:49.058Z</lastUpdated>
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    <udiDi>00850049735490</udiDi>
    <basicUdiDi>0850049735MXCT-57N</basicUdiDi>
    <tradeName>MagCTL Collection Tube (5 tubes)</tradeName>
    <deviceName>MagCTL Collection Tube (5 tubes)</deviceName>
    <manufacturerName>MagBio Genomics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038221</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXCT-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:30:01.195Z</lastUpdated>
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    <udiDi>00850045030018</udiDi>
    <basicUdiDi>0850045030MXCT-100B9</basicUdiDi>
    <tradeName>MagCTL Collection Tube (100 tubes)</tradeName>
    <deviceName>MagCTL Collection Tube (100 tubes)</deviceName>
    <manufacturerName>MagBio Genomics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038221</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXCT-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:28:59.944Z</lastUpdated>
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    <udiDi>00850039198007</udiDi>
    <basicUdiDi>0850039198105VD</basicUdiDi>
    <tradeName>903™</tradeName>
    <deviceName>903 Filter Paper</deviceName>
    <manufacturerName>Eastern Business Forms, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000047033</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W211 / 105xxxxx</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:41.332Z</lastUpdated>
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    <udiDi>00850038691110</udiDi>
    <basicUdiDi>0850038691TassoTileQE</basicUdiDi>
    <tradeName>Tile-T20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tasso, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017355</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN0583-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:20.982Z</lastUpdated>
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    <basicUdiDi>0850038691TassoKitKY</basicUdiDi>
    <tradeName>Tasso+ EDTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tasso, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000037252</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K1025-01-EDT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:20.169Z</lastUpdated>
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    <udiDi>00850027600543</udiDi>
    <basicUdiDi>0850027600R1160UDL</basicUdiDi>
    <tradeName>DNA/RNA Shield SafeCollect Swab Collection Kit (2mL)</tradeName>
    <deviceName>DNA/RNA Shield SafeCollect Swab Collection Kit</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>BIOTIKA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000045231</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1161-H</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:45.621Z</lastUpdated>
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    <udiDi>00850027600147</udiDi>
    <basicUdiDi>0850027600R1102F6</basicUdiDi>
    <tradeName>DNA/RNA Shield Collection Tube - 50 pack</tradeName>
    <deviceName>DNA/RNA Shield Collection Tube</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000006724</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1102-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:40.866Z</lastUpdated>
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    <udiDi>00850027600116</udiDi>
    <basicUdiDi>0850027600R1160FL</basicUdiDi>
    <tradeName>DNA/RNA Shield SafeCollect Saliva Collection Kit</tradeName>
    <deviceName>DNA/RNA Shield SafeCollect Swab Collection Kit (1mL)</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1211-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:39.732Z</lastUpdated>
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    <basicUdiDi>0850027600R1101F4</basicUdiDi>
    <tradeName>DNA/RNA Shield-Fecal Collection Tube - 10 pack</tradeName>
    <deviceName>DNA/RNA Shield Fecal Collection Tube - DX</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1101-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:23.152Z</lastUpdated>
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    <tradeName>DNA/RNA Shield Collection Tube w/Swab - DX (1 ml fill)</tradeName>
    <deviceName>DNA/RNA Shield Collection Tube w/ Swab - DX</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1107-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:18.352Z</lastUpdated>
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    <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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