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ADMIN KIT, Adynovi, BJ3, 5ML

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

Ref 3400809

EMDN A030499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850025688Lessines_PackSE Basic UDI-DIDate10 Dec 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Administration Kits for Advate, Adynovi and Rixubis
Model / Reference
3400809
Primary DI / UDI-DI
00198815000077
Basic UDI-DI
0850025688Lessines_PackSE
EMDN Code
A030499 Administration kits - other
Device Class
Class IIa
Medical Purpose
This administration kit is used for intravenous administration of your coagulation medicine, as indicated by your treating physician and described in the package leaflet.

Manufacturer details

EUDAMED SRN
US-PR-000007896

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

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 00198815000077|0850025688LESSINES_PACKSE 61 fields · synced 24 Oct 2026