Identity
- Trade Name
- BILIRUBIN TOTAL 4+1 EUDAMEDFDA UDI
- Generic Name
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- BILIRUBIN TOTAL 4+1 EUDAMED
- Model / Reference
- BITO-0250 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700817406 EUDAMEDFDA UDI
- Basic UDI-DI
- 37017008BITO008Q EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
- GMDN Term
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bilirubin Total 4+1 by Vitalscientific — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008BITO008Q | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 806c1cef-a857-4287-b06b-0db9a7d317e1 61 fields · synced Jun 8, 2026
- FDA UDI 271ff5d8-8935-47f5-8a37-ad81c805c67a 32 fields · synced May 30, 2026