FDA device listing
QiVi Acute MEC,VERSETTE
FDA device listing 1269448056 · Madewell Medical Technology (Malaysia) Sdn., Bhd.
Key facts
| Proprietary names | QiVi Acute MEC,VERSETTE |
|---|---|
| Owner/operator | Madewell Medical Technology (Malaysia) Sdn., Bhd. |
| Owner/operator number | 10092929 |
| Product codes | NZU |
| Device names | NZU - Collector, Urine, Powered, Non Indwelling Catheter |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | MADEWELL MEDICAL TECHNOLOGY (MALAYSIA) SDN., BHD. |
| Establishment registrations | 3038139564 |
| FEI numbers | 3038139564 |
| Establishment operations | 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