Identity
- Trade Name
- bCUBE 2.0 EUDAMEDbCUBE FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification instrument IVD, manual FDA UDI
- Device Name
- bCUBE 2.0 EUDAMEDReal-time PCR instrument. FDA UDI
- Model / Reference
- bCUBE 2.0 EUDAMEDFDA UDI
- Description
- Real-time PCR instrument. FDA UDI
Identifiers
- Catalog Number
- bCUBE 2.0 FDA UDI
- Primary DI / UDI-DI
- 80575074300098 EUDAMED08057507430009 FDA UDI
- Basic UDI-DI
- 805750743BCUBEA9 EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W02050180 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification instrument IVD, manual FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
bCUBE 2.0 by Hyris Srl — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 805750743BCUBEA9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (2)
- EUDAMED 5c6b6734-df5c-4b2a-bf23-18f62a0f9289 61 fields · synced Jun 19, 2026
- FDA UDI 0c47141f-d273-4841-83a2-2c385b42977b 34 fields · synced May 30, 2026