FDA device listing
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System)
FDA device listing 1438751756 · Ankon Medical Technologies (Shanghai) Co., Ltd.
Key facts
| Proprietary names | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) |
|---|---|
| Owner/operator | Ankon Medical Technologies (Shanghai) Co., Ltd. |
| Owner/operator number | 10062371 |
| Product codes | QKZ |
| Device names | QKZ - Magnetically Maneuvered Capsule Endoscopy System |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1310 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | ANKON MEDICAL TECHNOLOGIES (SHANGHAI) CO., LTD. |
| Establishment registrations | 3015198783 |
| FEI numbers | 3015198783 |
| 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