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    <basicUdiDi>5061107470184RR</basicUdiDi>
    <tradeName>05061107470184</tradeName>
    <deviceName>Inuvi-005/CE Collection Kit</deviceName>
    <manufacturerName>Inuvi Health Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000057167</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Inuvi-005/CE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:51:13.781Z</lastUpdated>
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    <udiDi>05061107470177</udiDi>
    <basicUdiDi>5061107470177RU</basicUdiDi>
    <tradeName>05061107470177</tradeName>
    <deviceName>Inuvi-004/CE Collection Kit</deviceName>
    <manufacturerName>Inuvi Health Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000057167</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Inuvi-004/CE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:51:09.758Z</lastUpdated>
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    <udiDi>05061107470160</udiDi>
    <basicUdiDi>5061107470160RB</basicUdiDi>
    <tradeName>05061107470160</tradeName>
    <deviceName>Inuvi-003/CE Collection Kit</deviceName>
    <manufacturerName>Inuvi Health Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000057167</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Inuvi-003/CE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:51:08.957Z</lastUpdated>
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    <udiDi>05061107470153</udiDi>
    <basicUdiDi>5061107470153RE</basicUdiDi>
    <tradeName>05061107470153</tradeName>
    <deviceName>Inuvi-001/CE Collection Kit</deviceName>
    <manufacturerName>Inuvi Health Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000057167</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Inuvi-001/CE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:51:08.158Z</lastUpdated>
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    <udiDi>04262522490684</udiDi>
    <basicUdiDi>426252249SCKTAPC9</basicUdiDi>
    <tradeName>04262522490684</tradeName>
    <deviceName>TAP Micro Select Sampling Kit</deviceName>
    <manufacturerName>Probatix Health GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000048885</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>SCK_TAP-1S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:21:55.191Z</lastUpdated>
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    <udiDi>04262522490646</udiDi>
    <basicUdiDi>426252249SCKTASSO2S</basicUdiDi>
    <tradeName>04262522490646</tradeName>
    <deviceName>Capillary Blood Sampling Kit SCK_TASSO</deviceName>
    <manufacturerName>Probatix Health GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000048885</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>SCK_TASSO-1S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:21:54.873Z</lastUpdated>
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    <udiDi>04251620707268</udiDi>
    <basicUdiDi>42516207002JR</basicUdiDi>
    <tradeName>cerascreen® Histamin-Intoleranz Test</tradeName>
    <deviceName>Probenahme- und Einsende-Kit Trockenblut</deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010520</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:09:23.313Z</lastUpdated>
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    <udiDi>04251620700344</udiDi>
    <basicUdiDi>42516207001JP</basicUdiDi>
    <tradeName>cerascreen® Kombi-Paket Berufliche Leistungsfähigke</tradeName>
    <deviceName>Probenahme- und Einsende-Kit Flüssigblut</deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99040007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:09:22.516Z</lastUpdated>
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    <udiDi>14053228010361</udiDi>
    <basicUdiDi>4053228MDIGENE0010000016Q</basicUdiDi>
    <tradeName>digene HC2 DNA Collection Device</tradeName>
    <deviceName>digene HC2 DNA Collection Device</deviceName>
    <manufacturerName>QIAGEN Sciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014502</manufacturerSrn>
    <authorisedRepresentativeName>QIAGEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004971</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>619234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:36:58.571Z</lastUpdated>
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    <udiDi>04066916059354</udiDi>
    <basicUdiDi>4038917SARTD02200U5T</basicUdiDi>
    <tradeName>Stuhlröhre 101x16,5mm</tradeName>
    <deviceName>Stuhlröhren</deviceName>
    <manufacturerName>SARSTEDT AG &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005649</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80.623.058</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:15.399Z</lastUpdated>
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  <row>
    <udiDi>10844509000836</udiDi>
    <basicUdiDi>08445090BCTTZ</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213559</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:07:19.876Z</lastUpdated>
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    <udiDi>00860013997663</udiDi>
    <basicUdiDi>08600139976PDSCK30BM026UC</basicUdiDi>
    <tradeName>Predicine Bone Marrow Aspirate (BMA) Collection Kit™</tradeName>
    <deviceName>Predicine Bone Marrow Aspirate (BMA) Collection Kit™</deviceName>
    <manufacturerName>Predicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031888</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>PD-SCK30BM-026,  PD-SCK30BM-027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:10.917Z</lastUpdated>
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    <udiDi>00860013997618</udiDi>
    <basicUdiDi>08600139976PDSCK30U003VU</basicUdiDi>
    <tradeName>Predicine Urine Collection Kit</tradeName>
    <deviceName>Predicine Urine Collection Kit</deviceName>
    <manufacturerName>Predicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031888</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010203</emdnCode>
    <emdnDescription>URINE COLLECTION, CONTAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD-SCK30U-003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:09.583Z</lastUpdated>
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    <udiDi>00860013997601</udiDi>
    <basicUdiDi>08600139976PDSCK30B007RX</basicUdiDi>
    <tradeName>Predicine Blood Collection Kit</tradeName>
    <deviceName>Predicine Blood Collection Kit</deviceName>
    <manufacturerName>Predicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031888</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>PD-SCK30B-007</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:05.894Z</lastUpdated>
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    <udiDi>00860013988098</udiDi>
    <basicUdiDi>08600139880BUDI0012G2</basicUdiDi>
    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card: Double-Double strip cards</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-DBL200SQ</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:03.487Z</lastUpdated>
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    <udiDi>00860013988081</udiDi>
    <basicUdiDi>08600139880BUDI0011FY</basicUdiDi>
    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card: Triple-Single strip cards</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-MEGA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:02.701Z</lastUpdated>
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    <udiDi>00860013988074</udiDi>
    <basicUdiDi>08600139880BUDI0010FW</basicUdiDi>
    <tradeName>Advance Dx Blood Collection Card</tradeName>
    <deviceName>Advance Dx Blood Collection Card: Double strip cards</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-DBL</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:01.091Z</lastUpdated>
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    <udiDi>00860013988067</udiDi>
    <basicUdiDi>08600139880BUDI0009GD</basicUdiDi>
    <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>
    <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>WTSSNG500</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:56.285Z</lastUpdated>
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    <udiDi>00860013988043</udiDi>
    <basicUdiDi>08600139880BUDI0007G9</basicUdiDi>
    <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>
    <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>WTSSNG100</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:54:55.508Z</lastUpdated>
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