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Administration Kit for Advate, ADMIN KIT, ADV, BJ3, 5ML

EUDAMED

Class IIa (EU MDR)

Ref 3400779

by Takeda Pharmaceuticals U.S.A., Inc.

Identity

Trade Name
Administration Kit for Advate, ADMIN KIT, ADV, BJ3, 5ML EUDAMED
Device Name
Administration Kits for Advate, Adynovi and Rixubis EUDAMED
Model / Reference
3400779 EUDAMED

Identifiers

Primary DI / UDI-DI
00850025688574 EUDAMED
Basic UDI-DI
0850025688Lessines_PackSE EUDAMED
EMDN Code
A030499 ADMINISTRATION KITS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
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. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Administration Kit for Advate, ADMIN KIT, ADV, BJ3, 5ML by Takeda Pharmaceuticals U.S.A., Inc. — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Takeda Pharmaceuticals U.S.A., Inc.
EUDAMED SRN
US-PR-000007896

Sources (1)

  • EUDAMED 3b0f39ce-3a00-47c9-b6e5-5138e26b14df 61 fields · synced Jun 19, 2026