Is this your brand? Sign in to claim ownership.
Sign in to claim this brandElite Biomedical Solutions
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elite Biomedical Solutions | B | FDA UDI | Class II | Active |
| Elite Biomedical Solutions Dose Request Cord | K220695 | 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 Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 3, 2015 | Z-2371-2015 | — | terminated | Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. |
| Jun 3, 2015 | Z-2372-2015 | — | terminated | Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. |