FDA device listing
Fundus Camera,Model:Kestrel 300,Fundus Camera,Model:RetiCam 3100 Plus
FDA device listing 1808575060 · Chongqing Bio NewVision Medical Equipment Ltd.
Key facts
| Proprietary names | Fundus Camera,Model:Kestrel 300,Fundus Camera,Model:RetiCam 3100 Plus |
|---|---|
| Owner/operator | Chongqing Bio NewVision Medical Equipment Ltd. |
| Owner/operator number | 10062546 |
| Product codes | PJZ |
| Device names | PJZ - Camera, Ophthalmic, General-Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.1120 |
| Review panels | Ophthalmic |
| Registered establishments | CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD. |
| Establishment registrations | 3016589969 |
| FEI numbers | 3016589969 |
| Establishment operations | 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