<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04250203263023</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Katheter ohne Ballon, a 10 Stück im Beutel, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275095</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Kinderkatheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275101</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Luftkatheter, a 10 Stück im Beutel, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13704</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275118</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Ballonkatheter, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13706</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275125</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Ballonkatheter lang, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13708</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275132</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Luftkatheter mit Ballon, a 10 Stück im Beutel + 1 Luer-Lock Spritze pro Beutel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007341025</udiDi>
    <basicUdiDi>5065007341EnemaBulbU2</basicUdiDi>
    <tradeName>Enema Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>T2 Corporation Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045342</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-2024-A002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:42.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007341032</udiDi>
    <basicUdiDi>5065007341EnemaBulbU2</basicUdiDi>
    <tradeName>Enema Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>T2 Corporation Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045342</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-2024-A003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:42.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007341049</udiDi>
    <basicUdiDi>5065007341EnemaBulbU2</basicUdiDi>
    <tradeName>Enema Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>T2 Corporation Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045342</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-2024-A004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:42.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007341056</udiDi>
    <basicUdiDi>5065007341EnemaBulbU2</basicUdiDi>
    <tradeName>Enema Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>T2 Corporation Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045342</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-2024-A005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:42.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007341063</udiDi>
    <basicUdiDi>5065007341EnemaBulbU2</basicUdiDi>
    <tradeName>Enema Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>T2 Corporation Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045342</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-2024-A006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:42.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007341070</udiDi>
    <basicUdiDi>5065007341EnemaBulbU2</basicUdiDi>
    <tradeName>Enema Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>T2 Corporation Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045342</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-2024-A007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:14:42.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060551222707</udiDi>
    <basicUdiDi>5060551Enema5Z</basicUdiDi>
    <tradeName>Enema Irrigation Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FBGC LIMITED</manufacturerName>
    <manufacturerSrn>UK-MF-000046785</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-INT-EIK01-PNK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:12:09.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060551222387</udiDi>
    <basicUdiDi>5060551Enema5Z</basicUdiDi>
    <tradeName>Enema Irrigation Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FBGC LIMITED</manufacturerName>
    <manufacturerSrn>UK-MF-000046785</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-INT-TIK01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:11:54.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056622100258</udiDi>
    <basicUdiDi>5056622111583UX</basicUdiDi>
    <tradeName>05056622100258</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010291</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0106</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:21.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056622100241</udiDi>
    <basicUdiDi>5056622111583UX</basicUdiDi>
    <tradeName>05056622100241</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010291</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0144</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:20.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056622100234</udiDi>
    <basicUdiDi>5056622111583UX</basicUdiDi>
    <tradeName>05056622100234</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010291</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0142</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:19.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056622100227</udiDi>
    <basicUdiDi>5056622111583UX</basicUdiDi>
    <tradeName>05056622100227</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010291</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0139</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:18.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056622100210</udiDi>
    <basicUdiDi>5056622111583UX</basicUdiDi>
    <tradeName>05056622100210</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010291</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0135</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:17.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056622100203</udiDi>
    <basicUdiDi>5056622111583UX</basicUdiDi>
    <tradeName>05056622100203</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010291</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0134</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:16.764Z</lastUpdated>
  </row>
</eudamedExport>