Is this your brand? Sign in to claim ownership.
Sign in to claim this brandELUCENT MEDICAL INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6509 Flying Cloud Drive, Eden Prairie, MN, 55344
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014653199
- DUNS Number
- —
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SmartClip Secure | SMARTCLIP-SEC-GRN | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP-GRN-10 | FDA UDI | Class II | Unknown |
| SmartClip Secure | SMARTCLIP-SEC-PNK | FDA UDI | Class II | Active |
| EnVisio | NAV-SLIM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, GREEN, 7.5CM | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP LITE, PINK, 7.5CM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PURPLE, 5CM | FDA UDI | Class II | Unknown |
| EnVisio System | ENVISIO-SYS | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP LITE, GREEN, 10CM | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP LITE, GREEN, 5CM | FDA UDI | Class II | Active |
| EnVisio | ENVISIO-HUD1 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PURPLE, 5CM | FDA UDI | Class II | Active |
| EnVisio | ENVISIO-HUD2 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PINK, 10CM | FDA UDI | Class II | Unknown |
| SmartClip Secure | SMARTCLIP-SEC-PURP | FDA UDI | Class II | Active |
| EnVisio | NAV-SLIM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, GREEN, 10CM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP-PINK-10 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PINK, 5CM | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP LITE, PINK, 10CM | FDA UDI | Class II | Active |
| EnVisio | ENVISIO-SYS | FDA UDI | Class II | Active |
| EnVisio | ENVISIO-HUD2 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PURPLE, 7.5CM | FDA UDI | Class II | Active |
| SmartSensor | SMARTSENSOR | FDA UDI | Class II | Active |
| EnVisio | ENVISIO-PP1 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, GREEN, 7.5CM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PURPLE, 7.5CM | FDA UDI | Class II | Unknown |
| EnVisio | ENVISIO-PP1 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP-PINK-10 | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, GREEN, 5CM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PINK, 5CM | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP-PURP-10 | FDA UDI | Class II | Unknown |
| EnVisio | NAV-PENCIL | FDA UDI | Class II | Unknown |
| SmartClip | SMARTCLIP LITE, PINK, 7.5CM | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP LITE, PURPLE, 10CM | FDA UDI | Class II | Active |
| SmartClip | SMARTCLIP LITE, PURPLE, 10CM | FDA UDI | Class II | Unknown |
| SmartClip Delivery Catheter (ADR-1715) | K260565 | FDA 510(k) | Class II | Active |
| EnVisio Navigation Sytem | K183400 | FDA 510(k) | Class II | Active |
| SmartClip Secure Soft Tissue Marker | K233639 | FDA 510(k) | Class II | Active |
| SmartClip Soft Tissue Marker | K180640 | 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 (1)
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 |
|---|---|---|---|---|
| Nov 18, 2024 | Z-0806-2025 | — | open, classified | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. |