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<eudamedExport entity="devices">
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    <udiDi>06978111927490</udiDi>
    <basicUdiDi>697122740SPNRK</basicUdiDi>
    <tradeName>SPN-29*5</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>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Verifine</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:15.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111927513</udiDi>
    <basicUdiDi>697122740SPNRK</basicUdiDi>
    <tradeName>SPN-31*4</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>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Microdot</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:15.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08012992495032</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</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>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:25:53.503Z</lastUpdated>
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  <row>
    <udiDi>08012992495049</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</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>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DropSafe</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:25:53.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564462964</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564462971</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564462988</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564462995</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS2905</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564463008</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS2908</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564463015</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564463022</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>56971564463039</udiDi>
    <basicUdiDi>69715644600410ZQ</basicUdiDi>
    <tradeName>bexen medical</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:16:58.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>86992417733278</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>CCMED İINSULIN PEN NEEDLE 5mm 31 G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCF3105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>86992417733346</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>CCMED İINSULIN PEN NEEDLE 6mm 31 G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCF3106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.403Z</lastUpdated>
  </row>
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    <udiDi>86992417733414</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>CCMED İNSÜLİN KALEM İĞNESİ 8mm 31 G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCF3108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>86992417745776</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>İyon INSULIN PEN NEEDLE  8 mm  31G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN3108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.260Z</lastUpdated>
  </row>
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    <udiDi>86992417748814</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>İyon  INSULIN PEN NEEDLE 4 mm 31 G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN3104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>86992417748982</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>İyon INSULIN PEN NEEDLE 4mm 32 G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN3204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>86992417749040</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>İyon INSULIN PEN NEEDLE  5 mm 31G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN3105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>86992417749118</udiDi>
    <basicUdiDi>869924177PN6P</basicUdiDi>
    <tradeName>İyon INSULIN PEN NEEDLE  6mm 31 G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027085</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN3106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:31:08.184Z</lastUpdated>
  </row>
</eudamedExport>