<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850025688000</udiDi>
    <basicUdiDi>0850025688Baxject_IIF8</basicUdiDi>
    <tradeName>BAXJECT II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ASPIRATION AND TRANSFER FILTERS (&gt;= 5 MICRONS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3400737</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688017</udiDi>
    <basicUdiDi>0850025688Baxject_IIF8</basicUdiDi>
    <tradeName>BAXJECT II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ASPIRATION AND TRANSFER FILTERS (&gt;= 5 MICRONS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3400738</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688024</udiDi>
    <basicUdiDi>0850025688Baxject_IIF8</basicUdiDi>
    <tradeName>BAXJECT II, HI-FLOW</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ASPIRATION AND TRANSFER FILTERS (&gt;= 5 MICRONS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3400739</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688031</udiDi>
    <basicUdiDi>0850025688Baxject_IIF8</basicUdiDi>
    <tradeName>BAXJECT II, HI-FLOW</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ASPIRATION AND TRANSFER FILTERS (&gt;= 5 MICRONS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3400740</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688499</udiDi>
    <basicUdiDi>0850025688FlowEaseB7</basicUdiDi>
    <tradeName>FlowEase [Subcutaneous] Infusion Set, 6mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU1M3006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688505</udiDi>
    <basicUdiDi>0850025688FlowEaseB7</basicUdiDi>
    <tradeName>FlowEase [Subcutaneous] Infusion Set, 9mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU1M3009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688512</udiDi>
    <basicUdiDi>0850025688FlowEaseB7</basicUdiDi>
    <tradeName>FlowEase [Subcutaneous] Infusion Set, 12mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU1M3012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688949</udiDi>
    <basicUdiDi>0850025688VDZ-CDSTUK</basicUdiDi>
    <tradeName>00850025688949</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.428Z</lastUpdated>
  </row>
</eudamedExport>