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Direct Bilirubin
EUDAMEDClass B (EU MDR)
Ref BIDI-5600Model BIDI-0250Ref BIDI-6M10Model BIDI-M430
Identity
- Trade Name
- DIRECT BILIRUBIN EUDAMED
- Device Name
- BILIRUBIN DIRECT 4+1 EUDAMEDDIRECT BILIRUBIN EUDAMED
- Model / Reference
- BIDI-0250 EUDAMEDBIDI-5600 EUDAMEDBIDI-M430 EUDAMEDBIDI-6M10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700817314 EUDAMED03701700801825 EUDAMED03701700801801 EUDAMED
- Basic UDI-DI
- 37017008BIDI004A EUDAMED37017008BIDI014C 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
Direct Bilirubin 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 (3)
- EUDAMED 1e5f134f-274b-402e-8b4d-f0a2e7f54a31 61 fields · synced Jul 19, 2026
- EUDAMED ba149286-8a6b-48e3-a5c1-6f129404959e 61 fields · synced May 18, 2026
- EUDAMED 19567bcc-3f7b-4541-91c3-6ac271522cc9 61 fields · synced May 18, 2026