FDA device listing
xp-35A,xp-35B,XP-35C
FDA device listing 1971802268 · Guilin Yikeshi Medical Instrument Co Ltd
Key facts
| Proprietary names | xp-35A,xp-35B,XP-35C |
|---|---|
| Owner/operator | Guilin Yikeshi Medical Instrument Co Ltd |
| Owner/operator number | 10047368 |
| Product codes | EKG |
| Device names | EKG - Condenser, Amalgam And Foil, Operative |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | GUILIN YIKESHI Medical Device CO LTD |
| Establishment registrations | 3011215096 |
| FEI numbers | 3011215096 |
| 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