<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <basicUdiDi>B-8047BH</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>droplet</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>8047</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:59.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8046BF</udiDi>
    <basicUdiDi>B-8046BF</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>8046</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:58.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8045BD</udiDi>
    <basicUdiDi>B-8045BD</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>8045</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:57.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7349BV</udiDi>
    <basicUdiDi>B-7349BV</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>7349</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:10.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7348BT</udiDi>
    <basicUdiDi>B-7348BT</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>7348</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:09.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564461051</udiDi>
    <basicUdiDi>B-16971564461051</basicUdiDi>
    <tradeName>Critical Healthcare</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD DC05318</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:21.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564461044</udiDi>
    <basicUdiDi>B-16971564461044</basicUdiDi>
    <tradeName>Critical Healthcare</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD DC05316</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:21.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564461037</udiDi>
    <basicUdiDi>B-16971564461037</basicUdiDi>
    <tradeName>Critical Healthcare</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD DC05315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:18.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564461020</udiDi>
    <basicUdiDi>B-16971564461020</basicUdiDi>
    <tradeName>Critical Healthcare</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD DC05314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:16.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564461013</udiDi>
    <basicUdiDi>B-16971564461013</basicUdiDi>
    <tradeName>Critical Healthcare</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD DC05324</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:14.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564460764</udiDi>
    <basicUdiDi>B-16971564460764</basicUdiDi>
    <tradeName>CAINA</tradeName>
    <deviceName>Disposable Safety Insulin Pen Needles</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC06305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:14.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971564460757</udiDi>
    <basicUdiDi>B-16971564460757</basicUdiDi>
    <tradeName>CAINA</tradeName>
    <deviceName>Disposable Insulin Pen Needles</deviceName>
    <manufacturerName>Jiangsu Caina Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC05304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:27:12.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935491715304</udiDi>
    <basicUdiDi>B-16935491715304</basicUdiDi>
    <tradeName>SAFETY A.T/G</tradeName>
    <deviceName>Disposable Insulin Pen Needles</deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-10-632</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:29.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935491715236</udiDi>
    <basicUdiDi>B-16935491715236</basicUdiDi>
    <tradeName>SAFETY A.T/G</tradeName>
    <deviceName>Disposable Insulin Pen Needles</deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-10-631</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:28.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236204759</udiDi>
    <basicUdiDi>69492362N001QE</basicUdiDi>
    <tradeName>Sterile Insulin pen needles for Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Berpu Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000012430</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>I23304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:36.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236204766</udiDi>
    <basicUdiDi>69492362N001QE</basicUdiDi>
    <tradeName>Sterile Insulin pen needles for Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Berpu Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000012430</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>I23204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:34.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236204773</udiDi>
    <basicUdiDi>69492362N001QE</basicUdiDi>
    <tradeName>Sterile Insulin pen needles for Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Berpu Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000012430</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>I23204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:34.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236204797</udiDi>
    <basicUdiDi>69492362N001QE</basicUdiDi>
    <tradeName>Sterile Insulin pen needles for Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Berpu Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000012430</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>I23105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:33.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236204810</udiDi>
    <basicUdiDi>69492362N001QE</basicUdiDi>
    <tradeName>Sterile Insulin pen needles for Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Berpu Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000012430</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>I23106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:33.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236204834</udiDi>
    <basicUdiDi>69492362N001QE</basicUdiDi>
    <tradeName>Sterile Insulin pen needles for Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Berpu Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000012430</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>I23108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:33.677Z</lastUpdated>
  </row>
</eudamedExport>