Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBLUO ELECTRONICS SRL
US
Last updated May 30, 2026
What BLUO ELECTRONICS SRL makes
BLUO Electronics SRL manufactures a range of dental radiographic systems, including stationary and mobile intraoral x-ray units (both digital and analogue), as well as stationary panoramic and panoramic/tomographic systems (digital and analogue). Their product line also includes intraoral digital imaging sensors and cephalometric x-ray systems for dental and maxillofacial assessments. These devices are designed for intraoral and extraoral imaging in dental practices.
The company’s devices fall under Class II regulatory classification in the US, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to applicable US regulatory requirements for medical imaging equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does BLUO Electronics SRL manufacture?
BLUO Electronics SRL manufactures dental radiographic systems including stationary and mobile intraoral x-ray units (digital and analogue), stationary panoramic and panoramic/tomographic systems (digital and analogue), intraoral digital imaging sensors, and cephalometric x-ray systems for dental and maxillofacial imaging.
Where is BLUO Electronics SRL based?
BLUO Electronics SRL is based in the United States, where they manufacture their dental imaging equipment and adhere to applicable US regulatory requirements for medical devices.
Which regulatory registries list BLUO Electronics SRL's devices?
BLUO Electronics SRL's devices are listed in the FDA's Unique Device Identifier (UDI) database, which is the primary registry for medical devices in the United States where the company is based.
How are BLUO Electronics SRL's devices classified?
BLUO Electronics SRL's dental radiographic systems and imaging sensors are classified as Class II medical devices in the US regulatory system, indicating they require special controls for safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- fonadental.it
- —
- —
- [email protected]
- Phone
- +390245712171
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 514320345
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FONA ART Plus C | 8468463121 | FDA UDI | Class II | Active |
| StarX-1 | 9380000100 | FDA UDI | Class II | Active |
| PantOs DG xp | 8468200300 | FDA UDI | Class II | Active |
| PantOs 16 xp | 8468200100 | FDA UDI | Class II | Active |
| StarX PRO-1 | 9380001100 | FDA UDI | Class II | Active |
| StarX PRO-2 | 9380001200 | FDA UDI | Class II | Active |
| Stellaris 3D | 8468600000 | FDA UDI | Class II | Active |
| Stellaris 2D Ceph | 8468600008 | FDA UDI | Class II | Active |
| Stellaris 2D | 8468600007 | FDA UDI | Class II | Active |
| PantOs 16 xp Ceph | 8468200500 | FDA UDI | Class II | Active |
| FONA ART Plus | 8468260320 | FDA UDI | Class II | Active |
| IntraOs DG | 9325001300 | FDA UDI | Class II | Active |
| StarX-2 | 9380000200 | FDA UDI | Class II | Active |
| PantOs 16 xp | 8468201200 | FDA UDI | Class II | Active |
| Vario DG | 6280270 | FDA UDI | Class II | Active |
| Stellaris 3D Ceph | 8468600002 | FDA UDI | Class II | Active |
| FONA ART Plus C | 8468463221 | FDA UDI | Class II | Active |
| Fona Xdc | 9319001700 | FDA UDI | Class II | Active |
| IntraOs 70 | 9320201300 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.