Identity
- Trade Name
- Multi-functional Analyzer EUDAMED
- Device Name
- Multi-functional Analyzer EUDAMED
- Model / Reference
- VXELL FIVE EUDAMEDVXL-F05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975679490787 EUDAMED
- Basic UDI-DI
- 697567949VXLF05BB EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Multi-functional Analyzer by Hunan Ehome Health Technology Company Limited — 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 | 697567949VXLF05BB | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Ehome Health Technology Company Limited
- EUDAMED SRN
- CN-MF-000045177
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED d36d6fc8-b67c-4176-96dc-9906ec43fb60 61 fields · synced Jun 18, 2026