Identity
- Trade Name
- ISA Refrigerated 230V EUDAMED
- Device Name
- ISA Refrigerated Centrifuge, 230V IVD EUDAMED
- Model / Reference
- AFI-CI060R-E/IVD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760369880008 EUDAMED
- Basic UDI-DI
- 376036988CI060R-EFL EUDAMED
- Direct Marketing DI
- 03760369880008 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
ISA Refrigerated 230V by AFI Centrifuge — Class A — 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 | 376036988CI060R-EFL | Class A | Active |
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Manufacturer
- Manufacturer
- AFI Centrifuge
- EUDAMED SRN
- FR-MF-000001636
Sources (1)
- EUDAMED 925cab7f-6801-41dc-a103-d7d519dc6f2e 61 fields · synced Aug 1, 2026