Identity
- Trade Name
- Alpha-1 EUDAMED
- Device Name
- Clinical Centrifuge iFuge CS03 NXT EUDAMED
- Model / Reference
- iFuge CS03 NXT EUDAMEDAlpha-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89080197338534 EUDAMED
- Basic UDI-DI
- 8908019733CLI-CEN-03TM EUDAMED
- Direct Marketing DI
- 89080197338534 EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
Alpha-1 by Accumax Lab Devices Private Limited — 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 | 8908019733CLI-CEN-03TM | Class A | Active |
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Manufacturer
- Manufacturer
- Accumax Lab Devices Private Limited
- EUDAMED SRN
- IN-MF-000028076
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 9c147a36-9a65-4072-acc1-3ab729f22f2a 61 fields · synced Jun 18, 2026