FDA device listing
Callisto Fibre Optic Disposable,Easy Bright Laryngoscope,Europa Disposable,Freeway Plastic Disposable,ION, Timesco ION…
FDA device listing 1822011196 · Timesco Healthcare Ltd
Key facts
| Proprietary names | Callisto Fibre Optic Disposable,Easy Bright Laryngoscope,Europa Disposable,Freeway Plastic Disposable,ION, Timesco ION R, ION R, Timesco,Lunar Conventional,Optima Clx FIbre Optic,Optima Fibre Optic,Optima View RU Blade Video Laryngoscope,Optima View SU Blade Video Laryngoscope,Optima XL Fibre Optic,Shakerscope, Shakerscope, Timesco Single Use Skin,Sirius Eclipse, Optima Eclipse, Timesco ION,Sirius… |
|---|---|
| Owner/operator | Timesco Healthcare Ltd |
| Owner/operator number | 8021788 |
| Product codes | CCW |
| Device names | CCW - Laryngoscope, Rigid |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5540 |
| Review panels | Anesthesiology |
| Registered establishments | Timesco Healthcare Ltd |
| Establishment registrations | 8021788 |
| FEI numbers | 5682 |
| Establishment operations | Manufacturer, Remanufacturer, Repackager/Relabeler, Specification Developer |
| 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