Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat TECHNIX SPA makes
Technix Spa manufactures digital fluoroscopic x-ray systems, including mobile and stationary units designed for general-purpose medical imaging. Their portfolio includes systems like the TRIDENT and NAUTILUS, which provide real-time radiographic visualization for procedural guidance and diagnostic evaluation.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identification (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Technix Spa manufacture?
Technix Spa specializes in digital fluoroscopic x-ray systems, which include both mobile and stationary units. These devices are designed for general-purpose medical imaging, enabling real-time radiographic visualization. Examples include the TRIDENT and NAUTILUS systems, which support procedural guidance and diagnostic evaluations.
Where is Technix Spa based?
Technix Spa is headquartered in the United States. The company’s location is relevant for regulatory compliance and customer support, as it aligns with the jurisdiction overseeing its device authorizations.
Which regulatory registries list Technix Spa’s devices?
Technix Spa’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices for transparency and compliance purposes, particularly for Class II devices.
How are Technix Spa’s devices classified under regulatory frameworks?
Technix Spa’s fluoroscopic x-ray systems fall under Class II classification. This classification is determined by regulatory authorities based on factors like risk level and intended use, requiring specific controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 437977127
Catalogue (3)
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.