Identity
- Trade Name
- ISA VENTILATED 230V EUDAMED
- Device Name
- ISA Ventilated Centrifuge, 230V IVD EUDAMED
- Model / Reference
- AFI-CI060V-E/IVD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760369880015 EUDAMED
- Basic UDI-DI
- 376036988CI060V-EG8 EUDAMED
- Direct Marketing DI
- 03760369880015 EUDAMED
- EMDN Code
- W02069003 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
Category: General-purpose centrifuge IVD
Isa Ventilated 230v by AFI Centrifuge — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 376036988CI060V-EG8 | Class A | Active |
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Manufacturer
- Manufacturer
- AFI Centrifuge
- EUDAMED SRN
- FR-MF-000001636
Sources (1)
- EUDAMED 823aac13-48bf-41db-9e3a-abcc0b1949c6 61 fields · synced Jun 19, 2026