Identity
- Trade Name
- Direct Bilirubin EUDAMED
- Device Name
- Direct Bilirubin EUDAMED
- Model / Reference
- C0164 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-C0164LK EUDAMED
- Basic UDI-DI
- B-C0164LK EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
Direct Bilirubin by C.p.m. Compagnia Per La Medicina S.r.l. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-C0164LK | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C.p.m. Compagnia Per La Medicina S.r.l.
- EUDAMED SRN
- IT-MF-000010738
Sources (1)
- EUDAMED f5cc088c-1df8-4467-936d-d0a2d913ef9d 61 fields · synced Jun 18, 2026