<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00818392011012</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>N42001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011029</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>N42007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011074</udiDi>
    <basicUdiDi>081006243SIS132</basicUdiDi>
    <tradeName>SOL-CARE Insulin 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>INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100020IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011081</udiDi>
    <basicUdiDi>081006243SISR32F</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>100006IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011098</udiDi>
    <basicUdiDi>081006243SISR32F</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>100007IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011104</udiDi>
    <basicUdiDi>081006243SISR32F</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>100008IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011111</udiDi>
    <basicUdiDi>081006243SISR32F</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>100009IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011128</udiDi>
    <basicUdiDi>081006243SISR32F</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>100010IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011135</udiDi>
    <basicUdiDi>081006243SISR32F</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>100011IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011142</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>100060IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:49.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011166</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>100062IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011180</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>100064IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011210</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>100068IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011227</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>140084IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011234</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>140060IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011258</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>140075IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011265</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>140062IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011289</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>140077IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011296</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>140065IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818392011302</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>160084IM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:15:30.497Z</lastUpdated>
  </row>
</eudamedExport>