FDA device listing
QiVi Lite Male External Urine Management Device
FDA device listing 1954172489 · CM Technologies, Inc.
Key facts
| Proprietary names | QiVi Lite Male External Urine Management Device |
|---|---|
| Owner/operator | CM Technologies, Inc. |
| Owner/operator number | 10049590 |
| Product codes | NOA |
| Device names | NOA - Device, Paste-On For Incontinence, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CM Technologies, Inc., QNQ Design and Development Pvt. Ltd. |
| Establishment registrations | 3011802696, 3013524793 |
| FEI numbers | 3011802696, 3013524793 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database