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Sign in to claim this brandVIOPTIX, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 39655 Eureka Dr, Newark, CA, 94560
- Website
- vioptix.com
- —
- —
- [email protected]
- Phone
- 510-226-5860
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003965364
- DUNS Number
- 127211923
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| T.Ox SP Sensor | OXY-2-SPD-1 | FDA UDI | Class II | Active |
| Intra.Ox Smart Sensor | OXY2-DUR-1 | FDA UDI | Class II | Active |
| Intra.Ox Disposable Sheath | OXY2-STH-1 | FDA UDI | Class II | Active |
| Intra.Ox Optical QC Target | OXY2-QCT-1 | FDA UDI | Class II | Active |
| T.Ox SS Sensor | OXY2-SPI-1 | FDA UDI | Class II | Active |
| Intra.Ox™ 2.0 Handheld Tissue Oximeter | K233488 | FDA 510(k) | Class II | Active |
| Intra.Ox 2.0 Handheld Tissue Oximeter | K221010 | FDA 510(k) | Class II | Active |
| Intra.Ox Handheld Tissue Oximeter | K163472 | FDA 510(k) | Class II | Active |
| Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | K042657 | FDA 510(k) | Class II | Active |
| Lap.Ox™ Laparoscopic Tissue Oximeter | K250519 | FDA 510(k) | Class II | Active |
| Odissey Tissue Oximeter | K141234 | FDA 510(k) | Class II | Active |
| Intra. Ox Handheld Tissue Oximeter | K133983 | FDA 510(k) | Class II | Active |
| Intra.Ox 2.0 Handheld Tissue Oximeter | K191676 | FDA 510(k) | Class II | Active |
| Vesselink Microvascular Anastomotic Coupler System | K090679 | FDA 510(k) | Class II | Active |
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