<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05903999607210</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607227</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607234</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607241</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4031</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607258</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4032</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607265</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4033</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607272</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4034</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607289</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4035</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607296</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4036</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607302</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4037</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607319</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4038</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607326</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4039</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607357</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>AutoProtect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607364</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>AutoProtect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607388</udiDi>
    <basicUdiDi>B-05903999607388</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9627</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607593</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4071</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607609</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4072</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607616</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4073</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:12.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607623</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>Microdot droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4074</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:12.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999607630</udiDi>
    <basicUdiDi>590799609810EFH</basicUdiDi>
    <tradeName>Microdot droplet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4075</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:12.954Z</lastUpdated>
  </row>
</eudamedExport>