Identity
- Device Name
- UREA/BUN - COLOR EUDAMED
- Model / Reference
- 11536 EUDAMED11537 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287115369 EUDAMED08435287115376 EUDAMED
- Basic UDI-DI
- B-08435287115369 EUDAMEDB-08435287115376 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Urea/Bun - Color by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08435287115369 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED cd7db184-2279-4367-88d6-680d05b7d9ce 61 fields · synced Jul 30, 2026
- EUDAMED 496f61a4-a109-4292-8b7f-8841f668baa1 61 fields · synced May 18, 2026