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Bilirubin Direct 4+1
EUDAMEDFDA UDIClass B (EU MDR)
Ref BIDI-0250Ref BIDI-0500Ref BITD-6250
Identity
- Trade Name
- BILIRUBIN DIRECT 4+1 EUDAMEDFDA UDIBILIRUBIN DIRECT EUDAMED
- Generic Name
- Conjugated (direct) bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- BILIRUBIN DIRECT 4+1 EUDAMEDBILIRUBIN TOTAL DIRECT EUDAMED
- Model / Reference
- BIDI-0250 EUDAMEDFDA UDIBIDI-0500 EUDAMEDBITD-6250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700817208 EUDAMEDFDA UDI03701700817307 EUDAMED03701700817321 EUDAMED
- Basic UDI-DI
- 37017008BIDI004A EUDAMED37017008BITD006Z EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
- GMDN Term
- Conjugated (direct) 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 Direct 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 | 37017008BIDI004A | 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 (4)
- EUDAMED 99963fed-1379-4628-9390-286b17dc4fe0 61 fields · synced Sep 17, 2026
- EUDAMED 1b1196aa-0f21-4350-affa-72b4091aa39a 61 fields · synced May 17, 2026
- FDA UDI a445d802-6873-4104-8a1c-22f86fde022e 32 fields · synced May 30, 2026
- EUDAMED f933969f-b3ba-49e1-bfd7-41dfd24a7614 61 fields · synced Jul 8, 2026