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Baxject Ii
EUDAMEDClass I (EU MDR)
Ref 3400737Model BaxjectRef 3400740Ref 3400739
Identity
- Trade Name
- BAXJECT II EUDAMEDBAXJECT II, HI-FLOW EUDAMED
- Model / Reference
- Baxject EUDAMED3400737 EUDAMED3400740 EUDAMED3400739 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688000 EUDAMED00850025688031 EUDAMED00850025688024 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 EUDAMEDAustria 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 (3)
- EUDAMED a9ea676f-5c84-4789-9d66-9b8713c5279f 61 fields · synced Jul 26, 2026
- EUDAMED ac471704-adb0-48d8-bfa6-b428cb8539b9 61 fields · synced May 17, 2026
- EUDAMED f3bafafb-0b91-49bf-9376-c17e0ec77da8 61 fields · synced May 18, 2026