Identity
- Trade Name
- BILIRUBIN DIRECT 4+1 EUDAMED
- Device Name
- BILIRUBIN DIRECT 4+1 EUDAMED
- Model / Reference
- BIDI-0250 EUDAMEDBIDI-6050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700817222 EUDAMED
- Basic UDI-DI
- 37017008BIDI004A EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
Bilirubin Direct 4+1 by Vitalscientific — Class B — 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 | 37017008BIDI004A | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (1)
- EUDAMED 810e0de5-e627-409f-b764-ccc05c9bc9e8 61 fields · synced May 23, 2026