<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-7103AT</udiDi>
    <basicUdiDi>B-7103AT</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7103</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:39.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7102AR</udiDi>
    <basicUdiDi>B-7102AR</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:31.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996098798</udiDi>
    <basicUdiDi>B-05907996098798</basicUdiDi>
    <tradeName>Medlance Plus, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8474</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:10:29.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996098781</udiDi>
    <basicUdiDi>B-05907996098781</basicUdiDi>
    <tradeName>Medlance Plus, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8473</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:10:29.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996098538</udiDi>
    <basicUdiDi>B-05907996098538</basicUdiDi>
    <tradeName>Medlance Plus, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8727</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:10:28.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996098477</udiDi>
    <basicUdiDi>B-05907996098477</basicUdiDi>
    <tradeName>Medlance Plus, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8726</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:09:10.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996098460</udiDi>
    <basicUdiDi>B-05907996098460</basicUdiDi>
    <tradeName>Medlance Plus, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8725</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:09:09.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996098453</udiDi>
    <basicUdiDi>B-05907996098453</basicUdiDi>
    <tradeName>Medlance Plus, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8724</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:09:08.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999610159</udiDi>
    <basicUdiDi>B-05903999610159</basicUdiDi>
    <tradeName>Haemolance Plus</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6841</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:06:57.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999610142</udiDi>
    <basicUdiDi>B-05903999610142</basicUdiDi>
    <tradeName>Haemolance Plus</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6840</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:06:56.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999604486</udiDi>
    <basicUdiDi>B-05903999604486</basicUdiDi>
    <tradeName>Acti-Lance</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7999</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:06:55.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999604479</udiDi>
    <basicUdiDi>B-05903999604479</basicUdiDi>
    <tradeName>Acti-Lance</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7998</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:06:54.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903999604462</udiDi>
    <basicUdiDi>B-05903999604462</basicUdiDi>
    <tradeName>Acti-Lance</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7997</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:06:49.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06957138617027</udiDi>
    <basicUdiDi>69571386SL02WU</basicUdiDi>
    <tradeName>06957138617027</tradeName>
    <deviceName>Safety lancet</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>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:51:52.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715571828</udiDi>
    <basicUdiDi>69507155KKIT5SB</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName>blood glucose monitoring system</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-B12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:30.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715571804</udiDi>
    <basicUdiDi>69507155KKIT3S7</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName>blood glucose monitoring system</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-B12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:29.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715571798</udiDi>
    <basicUdiDi>69507155CKIT5PK</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName>blood glucose monitoring system</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGH10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:27.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715571781</udiDi>
    <basicUdiDi>69507155CKIT3PF</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGH10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:25.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715563076</udiDi>
    <basicUdiDi>69507155CKIT4PH</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName>blood glucose monitoring system</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGH11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:09.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945630144711</udiDi>
    <basicUdiDi>6945630101B9</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Disposable Blood Lancets</deviceName>
    <manufacturerName>Sterilance Medical (Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000002860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Soft 28G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:44:03.717Z</lastUpdated>
  </row>
</eudamedExport>