Identity
- Device Name
- [AUTOANALYZER] BA400 EUDAMED
- Model / Reference
- 83400ISE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287112290 EUDAMED
- Basic UDI-DI
- 8435287191BA40000000J5 EUDAMED
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
[autoanalyzer] Ba400 by Biosystems S.a. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8435287191BA40000000J5 | Class A | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (1)
- EUDAMED ef80e748-fa6a-4106-9472-b20c02db9a74 61 fields · synced Jun 19, 2026