<?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>00850025688314</udiDi>
    <basicUdiDi>0850025688myPKFiT_HCPsEF</basicUdiDi>
    <tradeName>00850025688314</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688321</udiDi>
    <basicUdiDi>0850025688myPKFiT_PatYV</basicUdiDi>
    <tradeName>00850025688321</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688338</udiDi>
    <basicUdiDi>0850025688Natpar_MixingFX</basicUdiDi>
    <tradeName>NATPAR MIXING DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000416</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688345</udiDi>
    <basicUdiDi>0850025688Natpar_MixingFX</basicUdiDi>
    <tradeName>NATPAR MIXING DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000505</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688352</udiDi>
    <basicUdiDi>0850025688Natpar_MixingFX</basicUdiDi>
    <tradeName>NATPAR MIXING DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000771</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688376</udiDi>
    <basicUdiDi>0850025688Natpar_MixingFX</basicUdiDi>
    <tradeName>NATPAR MIXING DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688383</udiDi>
    <basicUdiDi>0850025688Natpar_MixingFX</basicUdiDi>
    <tradeName>NATPAR MIXING DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000506</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688390</udiDi>
    <basicUdiDi>0850025688Natpar_MixingFX</basicUdiDi>
    <tradeName>NATPAR MIXING DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688406</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000418</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:44.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688413</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000494</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688420</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000495</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688437</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>5000498</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688444</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000489</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688451</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000770</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688468</udiDi>
    <basicUdiDi>0850025688Natpar_PenUH</basicUdiDi>
    <tradeName>Natpar Pen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Shire Pharmaceuticals Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000593</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000491</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.870Z</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>
</eudamedExport>