Identity
- Trade Name
- bCUBE3 EUDAMED
- Device Name
- bCUBE3 EUDAMED
- Model / Reference
- bCUBE3 EUDAMEDH0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80575074300166 EUDAMED
- Basic UDI-DI
- 805750743H0001XV EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
Category: Nucleic acid sample preparation instrument IVD
bCUBE3 by Hyris Srl — 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 | 805750743H0001XV | Class A | Active |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (1)
- EUDAMED 3b8d21be-d253-42b3-b6cc-cfa1175188a8 61 fields · synced Jun 18, 2026