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Auto Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref EHBT-75Ref VXL-STAR5Model VXELL FIVE Stellar
Identity
- Trade Name
- Auto Hematology Analyzer EUDAMEDAuto Hemotology Analyzer EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMEDAuto Hemotology Analyzer EUDAMED
- Model / Reference
- EHBT-75 EUDAMEDVXELL FIVE Stellar EUDAMEDVXL-STAR5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975679490305 EUDAMED06975679490794 EUDAMED
- Basic UDI-DI
- B-06975679490305 EUDAMEDB-06975679490794 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDItaly 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
Auto Hematology Analyzer by Hunan Ehome Health Technology Company Limited — 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-06975679490305 | Class IVD General | 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 (2)
- EUDAMED 44abe3be-73b0-4df6-a079-032c8a5c1f7f 61 fields · synced Oct 6, 2026
- EUDAMED c3359a60-bfa6-48e4-a9fd-979a4df53e15 61 fields · synced Jul 14, 2026