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Sign in to claim this brandLUMENDI LLC
United States·US-MF-000036672
Last updated May 24, 2026
Information
- Country
- United States
- Address
- 253, 253 Post Road West, WestPort, United States
- Website
- www.lumendi.com
- —
- —
- [email protected]
- Phone
- 8444810822
- PRRC Contact
- Dennis Daniels
- EUDAMED SRN
- US-MF-000036672
- FDA FEI Number
- —
- DUNS Number
- 859290897
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DiLumen Endolumenal Interventional Platform | DiLumen | FDA UDI | Class II | Active |
| DiLumen C1, 103 cm | DiLumen C1, 103 cm | EUDAMEDFDA UDI | Class II | Active |
| DiLumen C2 | DiLumen C2.2 130 cm | FDA UDI | Class II | Active |
| DiLumen C2 | DiLumen C2 103 cm | FDA UDI | Class II | Active |
| DiLumen C2 | DiLumen C2 130 cm | FDA UDI | Class II | Active |
| DiLumen Ig Interventional Grasper | DiLumen Ig 140 cm | FDA UDI | Class II | Active |
| DiLumen Is Endolumenal Interventional Scissors | DiLumen Is 95 cm | FDA UDI | Class II | Active |
| DiLumen C2 | DiLumen C2.2 103 cm | FDA UDI | Class II | Active |
| DiLumen C1, 130 cm | DiLumen C1, 130 cm | EUDAMEDFDA UDI | Class II | Active |
| DiLumen EZ1, 130 cm | DiLumen EZ1, 130 cm | EUDAMEDFDA UDI | Class II | Active |
| DiLumen Ik Endolumenal Interventional Knife | DiLumen Ik 95 cm | FDA UDI | Class II | Active |
| DiLumen C2 | DiLumen C2 168 cm | FDA UDI | Class II | Active |
| DiLumen EZ1, 103 cm | DiLumen EZ1, 103 cm | EUDAMEDFDA UDI | Class II | Active |
| DiLumen Is Endolumenal Interventional Scissors | DiLumen Is 140 cm | FDA UDI | Class II | Active |
| DiLumen Interventional Grasper | IgE 125cm | FDA UDI | Class II | Active |
| DiLumen Endolumenal Interventional Platform, 103 cm | DiLumen, 103 cm | EUDAMEDFDA UDI | Class II | Active |
| DiLumen Ik Endolumenal Interventional Knife | DiLumen Ik 140 cm | FDA UDI | Class II | Active |
| DiLumen Endolumenal Interventional Platform, 130 cm | DiLumen, 130 cm | EUDAMEDFDA UDI | Class II | Active |
| DiLumen Im Interventional Tool Mount | DiLumen Im | FDA UDI | Class I | Active |
| DiLumen Ig Interventional Grasper | DiLumen Ig 95 cm | FDA UDI | Class II | Active |
| DiLumen C2; DiLumen Tool Mount | K173317 | FDA 510(k) | Class II | Active |
| DiLumen Endolumenal Interventional Platform | K162428 | FDA 510(k) | Class II | Active |
| DiLumen C1, EZ1 and Tool Mount | K221452 | FDA 510(k) | Class II | Active |
| DiLumen C2 and Tool Mount | K211819 | FDA 510(k) | Class II | Active |
| DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | K183112 | FDA 510(k) | Class II | Active |
| DiLumen Endolumenal Interventional Scissors (DiLumen Is) | K173405 | FDA 510(k) | Class II | Active |
| DiLumen Endolumenal Interventional Platform (DiLumen) | K210851 | FDA 510(k) | Class II | Active |
| DiLumen Endolumenal Interventional Platform | K182540 | FDA 510(k) | Class II | Active |
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