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Bilirubin Total 4+1
EUDAMEDClass B (EU MDR)
Ref BITD-6400Ref BITO-5220Model BITO-0250Ref BITO-0600Ref BITO-5600
Identity
- Trade Name
- BILIRUBIN TOTAL 4+1 EUDAMED
- Device Name
- BILIRUBIN TOTAL DIRECT EUDAMEDBILIRUBIN TOTAL 4+1 EUDAMED
- Model / Reference
- BITD-6400 EUDAMEDBITO-0250 EUDAMEDBITO-5220 EUDAMEDBITO-0600 EUDAMEDBITO-5600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700817529 EUDAMED03701700817413 EUDAMED03701700817505 EUDAMED03701700817512 EUDAMED
- Basic UDI-DI
- 37017008BITD006Z EUDAMED37017008BITO008Q 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 Total 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 | 37017008BITD006Z | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (4)
- EUDAMED da3aaa94-3878-4c09-9451-003cffe28ec2 61 fields · synced Jul 30, 2026
- EUDAMED a716c461-f2ba-40fd-988f-33c9469ef2b1 61 fields · synced May 18, 2026
- EUDAMED ec5f4d05-da0f-45b1-a4fc-a8ffb0eb5f4e 61 fields · synced Jul 13, 2026
- EUDAMED 9a8b38fd-1e49-4c6f-aff2-f3fdbfec300e 61 fields · synced Jul 30, 2026