Is this your brand? Sign in to claim ownership.
Sign in to claim this brandZetrOZ Systems
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 56 Quarry Rd, Trumbull, CT, 06611
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010765975
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| sam | sam-12 | FDA UDI | Class II | Active |
| sam X1 | SA551 | FDA UDI | Class II | Active |
| sam 2.0 Long Duration Ultrasound Device for Home Use | SA271 | FDA UDI | Class II | Active |
| sam coupling patch | UB-12 | FDA UDI | Class II | Active |
| sam(R) Advanced Gel Capture Patch | UB-14 | FDA UDI | Class II | Active |
| sam(R) Advanced Gel Capture Patch | UB-14 | FDA UDI | Class II | Active |
| sam X1 Long Duration Ultrasound Device | K211513 | FDA 510(k) | Class II | Active |
| sam 2.0 Long Duration Ultrasound System | K191568 | FDA 510(k) | Class II | Active |
| SAM 3.0 Multi-Hour Continuous Ultrasound Device | K260076 | FDA 510(k) | Class II | Active |
| sam 2.0 Long Ultrasound Device | K223019 | FDA 510(k) | Class II | Active |
| sam CS Long Duration Ultrasound Device | K233210 | FDA 510(k) | 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.