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    <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>I23404</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:33.563Z</lastUpdated>
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    <udiDi>06949236204896</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>I23404</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:57:03.800Z</lastUpdated>
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    <udiDi>08809445832151</udiDi>
    <basicUdiDi>B-08809445832151</basicUdiDi>
    <tradeName>TopFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34G(0.18mm) x 8mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:49.522Z</lastUpdated>
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    <udiDi>08809445832144</udiDi>
    <basicUdiDi>B-08809445832144</basicUdiDi>
    <tradeName>TopFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33G(0.20mm) x 8mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:45.507Z</lastUpdated>
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  <row>
    <udiDi>08809445832137</udiDi>
    <basicUdiDi>B-08809445832137</basicUdiDi>
    <tradeName>TopFine®</tradeName>
    <deviceName>Insullin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29G(0.33mm)x12mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:44.705Z</lastUpdated>
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  <row>
    <udiDi>08809445832120</udiDi>
    <basicUdiDi>B-08809445832120</basicUdiDi>
    <tradeName>TopFine®</tradeName>
    <deviceName>Insullin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29G(0.33mm)x10mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:43.908Z</lastUpdated>
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    <udiDi>08809445832090</udiDi>
    <basicUdiDi>B-08809445832090</basicUdiDi>
    <tradeName>TopFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32G(0.23mm) x 4mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:43.102Z</lastUpdated>
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  <row>
    <udiDi>08809445832076</udiDi>
    <basicUdiDi>B-08809445832076</basicUdiDi>
    <tradeName>TopFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33G(0.20mm) x 4mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:39.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809445832014</udiDi>
    <basicUdiDi>B-08809445832014</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34G(0.18mm) x 5mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:38.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809445832007</udiDi>
    <basicUdiDi>B-08809445832007</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34G(0.18mm) x 4mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:37.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809445831994</udiDi>
    <basicUdiDi>B-08809445831994</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33G(0.20mm) x 5mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:36.708Z</lastUpdated>
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  <row>
    <udiDi>08809445831987</udiDi>
    <basicUdiDi>B-08809445831987</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33G(0.20mm) x 4mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:08:04.358Z</lastUpdated>
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  <row>
    <udiDi>08809445831970</udiDi>
    <basicUdiDi>B-08809445831970</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32G(0.23mm) x 6mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:08:03.921Z</lastUpdated>
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  <row>
    <udiDi>08809445831963</udiDi>
    <basicUdiDi>B-08809445831963</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32G(0.23mm) x 5mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:08:02.737Z</lastUpdated>
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  <row>
    <udiDi>08809445831956</udiDi>
    <basicUdiDi>B-08809445831956</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32G(0.23mm) x 4mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:08:01.147Z</lastUpdated>
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  <row>
    <udiDi>08809445831949</udiDi>
    <basicUdiDi>B-08809445831949</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31G(0.25mm) x 8mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:07:58.733Z</lastUpdated>
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  <row>
    <udiDi>08809445831932</udiDi>
    <basicUdiDi>B-08809445831932</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31G(0.25mm) x 6mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:07:57.139Z</lastUpdated>
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  <row>
    <udiDi>08809445831925</udiDi>
    <basicUdiDi>B-08809445831925</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WellFine® 31G(0.25mm) x 5mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:07:56.331Z</lastUpdated>
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  <row>
    <udiDi>08809445831918</udiDi>
    <basicUdiDi>B-08809445831918</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30G(0.30mm) x 8mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:07:54.750Z</lastUpdated>
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  <row>
    <udiDi>08809445831901</udiDi>
    <basicUdiDi>B-08809445831901</basicUdiDi>
    <tradeName>WellFine®</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Medexel Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016654</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29G(0.33) x 12.7mm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:07:52.334Z</lastUpdated>
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