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<eudamedExport entity="devices">
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    <udiDi>08806133080573</udiDi>
    <basicUdiDi>880613308057DQ</basicUdiDi>
    <tradeName>C-tip (10 μL)</tradeName>
    <deviceName>C-tip (10 μL)</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-91</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:44:12.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133080566</udiDi>
    <basicUdiDi>880613308056DN</basicUdiDi>
    <tradeName>C-tip (30 μL)</tradeName>
    <deviceName>C-tip (30 μL)</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-199</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:44:10.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133080030</udiDi>
    <basicUdiDi>880613308003CZ</basicUdiDi>
    <tradeName>Microcuvettes</tradeName>
    <deviceName>Microcuvettes</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-27</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:44:10.109Z</lastUpdated>
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  <row>
    <udiDi>06980231236109</udiDi>
    <basicUdiDi>698023123DVBCT001RY</basicUdiDi>
    <tradeName>06980231236109</tradeName>
    <deviceName>DISPOSABLE VACCUM BLOOD COLLECTION TUBE</deviceName>
    <manufacturerName>SHANGHAI SUNSHORE MEDICAL INSTRUMENTS CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000056183</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>13x75mm(1-5ml)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:30:40.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975387351363</udiDi>
    <basicUdiDi>697538735VBCTUP</basicUdiDi>
    <tradeName>06975387351363</tradeName>
    <deviceName>Vacuum Blood Collection Tube</deviceName>
    <manufacturerName>SHANDONG CHENGWU HUABO MEDICAL EQUIPMENT CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000055916</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>Plain Tube-PET  1ml</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:01.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974617178398</udiDi>
    <basicUdiDi>697461717GLNTT</basicUdiDi>
    <tradeName>06974617178398</tradeName>
    <deviceName>Capillary Tube</deviceName>
    <manufacturerName>Hubei MeterOmega Technology LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000016732</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>178650</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:12:17.504Z</lastUpdated>
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  <row>
    <udiDi>06974617178374</udiDi>
    <basicUdiDi>697461717PLNV8</basicUdiDi>
    <tradeName>06974617178374</tradeName>
    <deviceName>Capillary Tube</deviceName>
    <manufacturerName>Hubei MeterOmega Technology LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000016732</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>178210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:12:13.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>16954152760385</udiDi>
    <basicUdiDi>6954152720232AsJCXGR5</basicUdiDi>
    <tradeName>Blood collection tube</tradeName>
    <deviceName>Single-use Containers for Human Venous Blood Specimen Collection</deviceName>
    <manufacturerName>Guangdong Kindly Medical Device Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006505</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>6038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:53:49.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>16954152760149</udiDi>
    <basicUdiDi>6954152720231AsJCXGQL</basicUdiDi>
    <tradeName>Blood collection tube</tradeName>
    <deviceName>Single-use Containers for Human Venous Blood Specimen Collection</deviceName>
    <manufacturerName>Guangdong Kindly Medical Device Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006505</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>6014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:53:49.380Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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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