Identity
- Trade Name
- ABX Pentra Ferritin Cal EUDAMED
- Device Name
- ABX Pentra Ferritin Cal EUDAMED
- Model / Reference
- A11A01619 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230004852 EUDAMED
- Basic UDI-DI
- 361023pentra_ferr_calZS EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
ABX Pentra Ferritin Cal by Horiba Abx Sas — 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 | 361023pentra_ferr_calZS | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (1)
- EUDAMED aa965505-d2ff-4455-8fec-6b8d647a84cd 61 fields · synced Jul 25, 2026