Identity
- Device Name
- ELSA-CA15-3 EUDAMED
- Model / Reference
- ELSA-CA15-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770024321104 EUDAMED
- Basic UDI-DI
- B-03770024321104 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 EUDAMED
Classification
- Device Class
- Class IVD General 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
Elsa-Ca15-3 by Cisbio Bioassays — 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-03770024321104 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cisbio Bioassays
- EUDAMED SRN
- FR-MF-000024051
Sources (1)
- EUDAMED 376d7ddf-106a-4fd4-8d2d-8ffa39bc569c 61 fields · synced Jul 11, 2026