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Baxject Ii, Hi-Flow

by Takeda Pharmaceuticals U.S.A., Inc. United States EUDAMED

Ref 3400740Model Baxject

EMDN A04010102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850025688Baxject_IIF8 Basic UDI-DIDate11 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Baxject, 3400740
Primary DI / UDI-DI
00850025688031
Basic UDI-DI
0850025688Baxject_IIF8
EMDN Code
A04010102 Aspiration and transfer filters (>= 5 microns)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000014749
Authorised representative
Takeda Pharmaceuticals International AG Ireland Branch IE-AR-000037116

Other devices from Takeda Pharmaceuticals U.S.A., Inc.

See all devices from Takeda Pharmaceuticals U.S.A., Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ac471704-adb0-48d8-bfa6-b428cb8539b9 61 fields · synced 22 Oct 2026