FDA device listing
CO2-CRYO Cryo Therapy System
FDA device listing 1704248192 · Rhein Laser Technologies Co., Ltd.
Key facts
| Proprietary names | CO2-CRYO Cryo Therapy System |
|---|---|
| Owner/operator | Rhein Laser Technologies Co., Ltd. |
| Owner/operator number | 10087178 |
| Product codes | KSP |
| Device names | KSP - Apparatus, Cell-Freezing And Reagents |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.9225 |
| Review panels | Hematology |
| Registered establishments | RHEIN LASER TECHNOLOGIES CO., LTD. |
| Establishment registrations | 3026038437 |
| FEI numbers | 3026038437 |
| 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