Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat OXAVITA S.R.L. makes
Oxavita S.R.L. manufactures portable hyperbaric chambers designed for medical and therapeutic use, including the Revitalair model. These devices are intended for controlled oxygen therapy in compact, mobile configurations, suitable for clinical or home settings.
The company’s products fall under FDA Class II regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. Oxavita S.R.L. 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 Oxavita S.R.L. manufacture?
Oxavita S.R.L. specializes in portable hyperbaric chambers, such as the Revitalair model. These devices are designed for controlled oxygen therapy and are intended for use in both clinical and home settings, offering a compact and mobile solution for therapeutic applications.
Where is Oxavita S.R.L. based?
Oxavita S.R.L. is headquartered in the United States. The company’s location influences its regulatory compliance and market focus, particularly in regions where its devices are authorized for use.
Which regulatory registries or databases list Oxavita S.R.L.’s devices?
Oxavita S.R.L.’s devices, including portable hyperbaric chambers like Revitalair, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for commercial distribution in the U.S.
How are Oxavita S.R.L.’s devices classified under FDA regulations?
Oxavita S.R.L.’s hyperbaric chambers, such as the Revitalair model, fall under FDA Class II classification. This classification typically applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sigmabiomedical.com
- —
- —
- [email protected]
- Phone
- 786-416-5587
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 979052144
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Revitalair | 430F | 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.