Identity
- Device Name
- CONCENTRATED WASHING SOLUTION EUDAMED
- Model / Reference
- BO13416 EUDAMEDAC16434 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287134162 EUDAMED08435287106138 EUDAMED
- Basic UDI-DI
- 8435287190CONCWASHSoTF EUDAMED
- EMDN Code
- W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Concentrated Washing Solution 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 | 8435287190CONCWASHSoTF | Class A | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 13bd4e09-69dc-4836-96ae-020f7ac24f08 61 fields · synced Jul 11, 2026
- EUDAMED 063a80d3-5c68-4108-bb9d-5f85bad2df0b 61 fields · synced May 19, 2026