Identity
- Trade Name
- BAXJECT II EUDAMED
- Model / Reference
- Baxject EUDAMED3400738 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688017 EUDAMED
- Basic UDI-DI
- 0850025688Baxject_IIF8 EUDAMED
- EMDN Code
- A04010102 ASPIRATION AND TRANSFER FILTERS (>= 5 MICRONS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Baxject Ii by Takeda Pharmaceuticals U.S.A., Inc. — Class I — 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 | 0850025688Baxject_IIF8 | Class I | Active |
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Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
- EUDAMED SRN
- US-MF-000014749
- Authorised Representative
- Takeda Pharmaceuticals International AG Ireland Branch IE-AR-000037116
Sources (1)
- EUDAMED 0e1a5c4f-6d1f-4bc0-b76e-d386c97200f9 61 fields · synced Jun 8, 2026