Identity
- Device Name
- CaloPix 5.2.12 EUDAMED
- Model / Reference
- CaloPix 5.2.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FRMF000002560CPX52126V EUDAMED
- Basic UDI-DI
- B-FRMF000002560CPX52126V EUDAMED
- EMDN Code
- W0202050392 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
CaloPix 5.2.12 by Tribun Health — 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-FRMF000002560CPX52126V | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tribun Health
- EUDAMED SRN
- FR-MF-000002560
Sources (1)
- EUDAMED 2a2006dc-5e98-4056-a59e-4501236d4cb7 61 fields · synced Jun 18, 2026