<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00818392018141</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>SN2558S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018158</udiDi>
    <basicUdiDi>081006243BCA2UN</basicUdiDi>
    <tradeName>SOL-M Tube Holder with Luer Lock Adapter</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>HOLDERS FOR COLLECTION NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110201050003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018172</udiDi>
    <basicUdiDi>081006243SR320UD</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe without 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 WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018196</udiDi>
    <basicUdiDi>081006243SR320UD</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe without 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 WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018219</udiDi>
    <basicUdiDi>081006243SR320UD</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe without 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 WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018240</udiDi>
    <basicUdiDi>081006243SR320UD</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe without 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 WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018257</udiDi>
    <basicUdiDi>081006243SR320UD</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe without 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 WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018264</udiDi>
    <basicUdiDi>081006243SR320UD</basicUdiDi>
    <tradeName>SOL-M Luer Lock Syringe without 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 WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018271</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>N42009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018288</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Winged Infusion Set</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>213412SI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018295</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Winged Infusion Set</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>233412SI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018301</udiDi>
    <basicUdiDi>081006243SBC1YC</basicUdiDi>
    <tradeName>SOL-CARE Safety Winged Infusion Set</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>253412SI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018394</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>160072IMPRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018400</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>190072IMPRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018417</udiDi>
    <basicUdiDi>081006243SSR64T</basicUdiDi>
    <tradeName>SOL-CARE Safety 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>INFUSION AND IRRIGATION SYRINGES, WITHOUT CONE, WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100006IMPRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018844</udiDi>
    <basicUdiDi>081006243SSC93L</basicUdiDi>
    <tradeName>SOL-CARE Luer Lock Syringe with 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>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12338SN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018936</udiDi>
    <basicUdiDi>081006243SSC93L</basicUdiDi>
    <tradeName>SOL-CARE Luer Lock Syringe with 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>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52215SN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392018950</udiDi>
    <basicUdiDi>081006243SSC93L</basicUdiDi>
    <tradeName>SOL-CARE Luer Lock Syringe with 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>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12558SN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392019230</udiDi>
    <basicUdiDi>081006243ORL434</basicUdiDi>
    <tradeName>SOL-M Oral Dispensing Syringe Clear with Tip Cap</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>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21001GC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392019247</udiDi>
    <basicUdiDi>081006243ORL434</basicUdiDi>
    <tradeName>SOL-M Oral Dispensing Syringe Clear with Tip Cap</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>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21003GC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:25.513Z</lastUpdated>
  </row>
</eudamedExport>