Identity
- Trade Name
- ADMIN KIT, Advate, BJ2, 5ML EUDAMED
- Device Name
- Administration Kits for Advate, Adynovi and Rixubis EUDAMED
- Model / Reference
- 6510330 EUDAMED6512370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688611 EUDAMED00850025688789 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
ADMIN KIT, Advate, BJ2, 5ML by Takeda Pharmaceuticals U.S.A., Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
- EUDAMED SRN
- US-PR-000007896
Sources (2)
- EUDAMED daae5c6c-88f3-4001-8905-bcb532552167 61 fields · synced Jul 9, 2026
- EUDAMED da7478e4-1cd6-47d1-91f5-7f623abd7417 61 fields · synced May 18, 2026