<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06934047924705</udiDi>
    <basicUdiDi>69340479EU13RX</basicUdiDi>
    <tradeName>Insulin Pen Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Medsun Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011842</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>IPN3205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:45:03.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934047924712</udiDi>
    <basicUdiDi>69340479EU13RX</basicUdiDi>
    <tradeName>Insulin Pen Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Medsun Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011842</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>IPN3206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:45:03.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934047924729</udiDi>
    <basicUdiDi>69340479EU13RX</basicUdiDi>
    <tradeName>Insulin Pen Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Medsun Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011842</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>IPN3304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:45:02.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236215168</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>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:55.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236215175</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>I23205</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:55.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236215182</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>6611171</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:55.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236215199</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>6611172</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:55.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236216059</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>2026-07-09T08:58:54.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236216233</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>3664666010604</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:54.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236216240</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>3664666010598</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:54.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236216950</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>2026-07-09T08:58:54.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236220483</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>361310-31-5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:53.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949236220490</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>361310-32-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:58:53.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697427700945</udiDi>
    <basicUdiDi>B-08697427700945</basicUdiDi>
    <tradeName>AYSETFINE</tradeName>
    <deviceName>Aysetfine Insulin Pen Needles 32G 0.23x6mm</deviceName>
    <manufacturerName>AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000016409</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>70094</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:47:48.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697427700884</udiDi>
    <basicUdiDi>B-08697427700884</basicUdiDi>
    <tradeName>AYSETFINE</tradeName>
    <deviceName>Aysetfine Insulin Pen Needles 31G 0.25x6mm</deviceName>
    <manufacturerName>AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000016409</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>70088</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:47:46.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697427700877</udiDi>
    <basicUdiDi>B-08697427700877</basicUdiDi>
    <tradeName>AYSETFINE</tradeName>
    <deviceName>Aysetfine Insulin Pen Needles 31G 0.25x5mm</deviceName>
    <manufacturerName>AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000016409</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>70087</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:47:44.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996093434</udiDi>
    <basicUdiDi>590799609810MR</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:50:40.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996093441</udiDi>
    <basicUdiDi>590799609810MR</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:50:40.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996093458</udiDi>
    <basicUdiDi>590799609810MR</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:50:40.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996093465</udiDi>
    <basicUdiDi>590799609810MR</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:50:40.615Z</lastUpdated>
  </row>
</eudamedExport>