Is this your brand? Sign in to claim ownership.
Sign in to claim this brandVoluntis Sa.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Insulia | Redwing W_1.6_US | FDA UDI | Class II | Active |
| Insulia | Redwing 1WUS | FDA UDI | Class II | Unknown |
| Insulia | Redwing A_1.6_US | FDA UDI | Class II | Active |
| Insulia | Redwing I_1.6_US | FDA UDI | Class II | Active |
| Insulia | Redwing 1AUS | FDA UDI | Class II | Unknown |
| Insulia | REdwing 1IUS | FDA UDI | Class II | Unknown |
| Insulia Diabetes Management Companion | K202596 | FDA 510(k) | Class II | Active |
| Insulia Diabetes Management Companion | K172177 | FDA 510(k) | Class II | Active |
| Insulia Diabetes Management Companion | K170669 | FDA 510(k) | Class II | Active |
| Insulia Bolus Companion | K232451 | FDA 510(k) | Class II | Active |
| Insulia Diabetes Management Companion | K161433 | 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.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Voluntis Rueil-Malmaison Hauts-de-Seine · FR FEI 3013530341