<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10810018096646</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:30.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430250</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430267</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430274</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430298</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430304</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430311</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062430335</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062431035</udiDi>
    <basicUdiDi>081006243ACC2UM</basicUdiDi>
    <tradeName>SOL-M Syringe Tip Cap, Blue (Bulk, Sterile)</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>CAPS OR OBTURATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STCB01BS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062431042</udiDi>
    <basicUdiDi>081006243ACC2UM</basicUdiDi>
    <tradeName>SOL-M Syringe Tip Cap, Red (Bulk, Sterile)</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>CAPS OR OBTURATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STCB02BS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062431837</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062433848</udiDi>
    <basicUdiDi>081006243ADR1W5</basicUdiDi>
    <tradeName>SOL-GUARD Auto-Disable 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>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADR012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810062434852</udiDi>
    <basicUdiDi>081006243NDL1YE</basicUdiDi>
    <tradeName>SOL-M Hypodermic 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112234</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392010319</udiDi>
    <basicUdiDi>081006243ORL11WQ</basicUdiDi>
    <tradeName>SOL-M Catheter Tip 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>180060CT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392010586</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SN2115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392010593</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SN2010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392010609</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SN2015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392010630</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SN1810</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392010647</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SN1815</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>10818392011750</udiDi>
    <basicUdiDi>081006243ORL638</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21001OC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:17.688Z</lastUpdated>
  </row>
</eudamedExport>