<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05907996094035</udiDi>
    <basicUdiDi>B-05907996094035</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>Pen needle</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6758013-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:09:04.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996094011</udiDi>
    <basicUdiDi>B-05907996094011</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>Pen needle</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6758012-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:09:04.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996091676</udiDi>
    <basicUdiDi>B-05907996091676</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>pen needle</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8167</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:09:04.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996091669</udiDi>
    <basicUdiDi>B-05907996091669</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>pen needle</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8166</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:08:59.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907506237754</udiDi>
    <basicUdiDi>B-05907506237754</basicUdiDi>
    <tradeName>Haemofine</tradeName>
    <deviceName>pen needle</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8000</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:08:58.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607410</udiDi>
    <basicUdiDi>B-05904109607410</basicUdiDi>
    <tradeName>DOZ MED Injection needle 18G/1,2 mmx40 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-12X40-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:18.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607397</udiDi>
    <basicUdiDi>B-05904109607397</basicUdiDi>
    <tradeName>DOZ MED Injection needle 21G/0,8 mmx40 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-08X40-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:13.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607403</udiDi>
    <basicUdiDi>B-05904109607403</basicUdiDi>
    <tradeName>DOZ MED Injection needle 20G/0,9 mmx40 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-09X40-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:12.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607380</udiDi>
    <basicUdiDi>B-05904109607380</basicUdiDi>
    <tradeName>DOZ MED Injection needle 22G/0,7 mmx30 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-07X30-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:11.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607373</udiDi>
    <basicUdiDi>B-05904109607373</basicUdiDi>
    <tradeName>DOZ MED Injection needle 23G/0,6 mmx30 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-06X30-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:10.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607366</udiDi>
    <basicUdiDi>B-05904109607366</basicUdiDi>
    <tradeName>DOZ MED Injection needle 23G/0,6 mmx25 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-06X25-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:05.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109607359</udiDi>
    <basicUdiDi>B-05904109607359</basicUdiDi>
    <tradeName>DOZ MED Injection needle 25G/0,5 mmx16 mm</tradeName>
    <deviceName>sterile hypodermic needles</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-05X16-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:07:04.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045106154</udiDi>
    <basicUdiDi>88000451002MW</basicUdiDi>
    <tradeName>Feel Fine</tradeName>
    <deviceName>Sterile Single-use Insulin Pen Needle</deviceName>
    <manufacturerName>FEEL TECH BIO CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000032555</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPN-001</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:17.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>18058090055386</udiDi>
    <basicUdiDi>8058090PN510000FL</basicUdiDi>
    <tradeName>Ultimate V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pikdare S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000010069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81031531007000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:13:09.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058090054979</udiDi>
    <basicUdiDi>8058090PN310000ES</basicUdiDi>
    <tradeName>Ultimate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pikdare S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000010069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81021830101000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:09:28.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972857296124</udiDi>
    <basicUdiDi>697285729042A</basicUdiDi>
    <tradeName>Contour comfort</tradeName>
    <deviceName>Pen Needles</deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04-3204</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:01:51.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971227409577</udiDi>
    <basicUdiDi>697122740SPNRK</basicUdiDi>
    <tradeName>verifine</tradeName>
    <deviceName>safety pen needle</deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPN-31*5</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:59:31.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971227403346</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>Verifine</tradeName>
    <deviceName>Insulin Pen Needles</deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPN-31-6</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:59:26.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958697622781</udiDi>
    <basicUdiDi>69586976HWZSZ0017B</basicUdiDi>
    <tradeName>WOLF Hypodermic needle 14G X 1 1/2"</tradeName>
    <deviceName>Sterile hypodermic needles for single use</deviceName>
    <manufacturerName>Anhui Hongyu Wuzhou Medical Manufacturer CO.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029789</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T10916</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:52:31.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>06957138617157</udiDi>
    <basicUdiDi>69571386PD08VB</basicUdiDi>
    <tradeName>06957138617157</tradeName>
    <deviceName>Pen needle</deviceName>
    <manufacturerName>Tianjin Huahong Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015849</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:51:54.798Z</lastUpdated>
  </row>
</eudamedExport>