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Administration Kit for Advate, ADMIN KIT, ADV, BJ3, 2ML
EUDAMEDClass IIa (EU MDR)
Ref 3400784Ref 3400776
Identity
- Trade Name
- Administration Kit for Advate, ADMIN KIT, ADV, BJ3, 2ML EUDAMED
- Device Name
- Administration Kits for Advate, Adynovi and Rixubis EUDAMED
- Model / Reference
- 3400784 EUDAMED3400776 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688697 EUDAMED00850025688567 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, 2ML 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850025688Lessines_PackSE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
- EUDAMED SRN
- US-PR-000007896
Sources (2)
- EUDAMED 79a37ef6-8bbe-4b7d-89bf-c467d9c788a6 61 fields · synced Jul 21, 2026
- EUDAMED 55eacee9-361d-4eec-ae13-c30570ac79a4 61 fields · synced May 18, 2026