<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944413826069</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100BN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:35.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826052</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-85AN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:34.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826038</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-85AN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:32.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826021</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-115BY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:28.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826007</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-115BY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:26.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413825994</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100AY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:24.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413825970</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100AY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:22.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942826216675</udiDi>
    <basicUdiDi>697079159CATA000A00N78</basicUdiDi>
    <tradeName>CITOGLAS</tradeName>
    <deviceName>Capillary Tubes</deviceName>
    <manufacturerName>CITOTEST LABWARE MANUFACTURING CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017214</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5810-0002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T00:42:45.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500594200586</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>5 Microliters MICROSAFE, 2000 tubes</tradeName>
    <deviceName></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>1005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:01.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500594200654</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>10 Microliters MICROSAFE (short), 2000 tubes</tradeName>
    <deviceName></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>1010S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:01.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500594200722</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>15 Microliters MICROSAFE, 2000 tubes</tradeName>
    <deviceName></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>1015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:01.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500594200890</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>17 Microliters MICROSAFE, 2000 tubes</tradeName>
    <deviceName></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>1017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:01.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500594200968</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>20 Microliters MICROSAFE, 2000 tubes</tradeName>
    <deviceName></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>1020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:01.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500594201026</udiDi>
    <basicUdiDi>0850059420MICROSAF8090NR</basicUdiDi>
    <tradeName>25 Microliters MICROSAFE, 2000 tubes</tradeName>
    <deviceName></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>1025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:01.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600609449078</udiDi>
    <basicUdiDi>56006094490DEVICE2B</basicUdiDi>
    <tradeName>spinit®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>biosurfit SA</manufacturerName>
    <manufacturerSrn>PT-MF-000033920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950105</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:42:01.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600609449092</udiDi>
    <basicUdiDi>56006094490AHLTTA2Z</basicUdiDi>
    <tradeName>At-home Lab Testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>biosurfit SA</manufacturerName>
    <manufacturerSrn>PT-MF-000033920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0501010280</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHLT_006</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:42:01.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009710130308</udiDi>
    <basicUdiDi>600971013DBSC5</basicUdiDi>
    <tradeName>DBS KIT (TFN; 20) WITHOUT CAPILLARY TUBES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lasec International (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000040804</manufacturerSrn>
    <authorisedRepresentativeName>TNMC Devices Llc</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HR-AR-000019582</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KKIT-EXP20TSU-TFN-CB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:53:52.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>06429810164056</udiDi>
    <basicUdiDi>6429810164DBSKIT9M</basicUdiDi>
    <tradeName>Blood Collection Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nightingale Health Oyj</manufacturerName>
    <manufacturerSrn>FI-MF-000021253</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGH-0701</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:52.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065019690012</udiDi>
    <basicUdiDi>5065019690AHBCKUS</basicUdiDi>
    <tradeName>Immuno-T At Home Blood Collection Kit II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ImmunoServ Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000049445</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHBCK II</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:20.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850024881082</udiDi>
    <basicUdiDi>850024881BOSB</basicUdiDi>
    <tradeName>LetsGetChecked Blood Home Sample Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PrivaPath Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000045162</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>BO11I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:45.195Z</lastUpdated>
  </row>
</eudamedExport>