<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00383017947736</udiDi>
    <basicUdiDi>0383017LGPNNDLSCPVK</basicUdiDi>
    <tradeName>Ultra-Fine Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>embecta Medical II LLC</manufacturerName>
    <manufacturerSrn>US-MF-000044225</manufacturerSrn>
    <authorisedRepresentativeName>embecta Penel Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000040945</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>329477</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:47.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383017947835</udiDi>
    <basicUdiDi>0383017LGPNNDLSCPVK</basicUdiDi>
    <tradeName>Micro-Fine Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>embecta Medical II LLC</manufacturerName>
    <manufacturerSrn>US-MF-000044225</manufacturerSrn>
    <authorisedRepresentativeName>embecta Penel Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000040945</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>329478</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:47.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>54031881904201</udiDi>
    <basicUdiDi>4031881G10-02aIIaUV</basicUdiDi>
    <tradeName>KD-PENOFINE</tradeName>
    <deviceName>KD-PENOFINE Pen Needles</deviceName>
    <manufacturerName>KD Medical GmbH Hospital Products</manufacturerName>
    <manufacturerSrn>DE-MF-000006773</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>904206T</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:10:32.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454197</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454203</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454210</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454234</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454265</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454289</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033454296</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:53.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033455019</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22912</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:52.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033455026</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED  Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:52.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033455095</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:52.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033455101</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:52.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923033455118</udiDi>
    <basicUdiDi>69230334202002a01901MY</basicUdiDi>
    <tradeName>INSUNEED Insulin pen needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Kindly Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007594</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:09:52.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975965294921</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>4SURE</tradeName>
    <deviceName></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>NPN-31*5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:47.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975965294938</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>4SURE</tradeName>
    <deviceName></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>NPN-31*6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:47.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975965294945</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>4SURE</tradeName>
    <deviceName></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>NPN-31*8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:47.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975965294952</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>4SURE</tradeName>
    <deviceName></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>NPN-32*4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:47.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975965294969</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>4SURE</tradeName>
    <deviceName></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>NPN-32*5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:47.254Z</lastUpdated>
  </row>
</eudamedExport>