<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00818392016987</udiDi>
    <basicUdiDi>081006243SR34ZM</basicUdiDi>
    <tradeName>SOL-M Allergy Syringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392016994</udiDi>
    <basicUdiDi>081006243SN33YX</basicUdiDi>
    <tradeName>SOL-M Syringe with Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, WITHOUT CONE, WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017007</udiDi>
    <basicUdiDi>081006243SN33YX</basicUdiDi>
    <tradeName>SOL-M Sterile Syringe Multi-Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, WITHOUT CONE, WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017014</udiDi>
    <basicUdiDi>081006243penneedleKE</basicUdiDi>
    <tradeName>SOL-M Pen Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N42008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017021</udiDi>
    <basicUdiDi>081006243SIS132</basicUdiDi>
    <tradeName>SOL-CARE Insulin Safety Syringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100017IMPRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017038</udiDi>
    <basicUdiDi>081006243SSR14H</basicUdiDi>
    <tradeName>SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100072IMPRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017045</udiDi>
    <basicUdiDi>081006243SSR14H</basicUdiDi>
    <tradeName>SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>140072IMPRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017052</udiDi>
    <basicUdiDi>081006243SN32YV</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe with Exchangeable Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18323125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017069</udiDi>
    <basicUdiDi>081006243SN32YV</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe with Exchangeable Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18523125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017250</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Blood Collection Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201030030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017267</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Blood Collection Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201030031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017274</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Blood Collection Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201030032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017281</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Blood Collection Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201030033</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017298</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Blood Collection Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201030034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:26.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017304</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Blood Collection Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201030035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017359</udiDi>
    <basicUdiDi>081006243INS1ZJ</basicUdiDi>
    <tradeName>SOL-M Insulin Syringe with Fixed Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1653051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017366</udiDi>
    <basicUdiDi>081006243INS1ZJ</basicUdiDi>
    <tradeName>SOL-M Insulin Syringe with Fixed Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1613051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017441</udiDi>
    <basicUdiDi>081006243INS1ZJ</basicUdiDi>
    <tradeName>SOL-M Insulin Syringe with Fixed Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1653151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392017458</udiDi>
    <basicUdiDi>081006243INS1ZJ</basicUdiDi>
    <tradeName>SOL-M Insulin Syringe with Fixed Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1613151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018134</udiDi>
    <basicUdiDi>081006243SND12E</basicUdiDi>
    <tradeName>SOL-CARE Safety Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sol-Millennium Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010890</manufacturerSrn>
    <authorisedRepresentativeName>Sol-Millennium Europe Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000010397</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SN2310S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.905Z</lastUpdated>
  </row>
</eudamedExport>