FDA device listing
SOFTGUARDS Disposable Medical Mask
FDA device listing 1787142856 · KAO CHEN ENTERPRISE CO., LTD.
Key facts
| Proprietary names | SOFTGUARDS Disposable Medical Mask |
|---|---|
| Owner/operator | KAO CHEN ENTERPRISE CO., LTD. |
| Owner/operator number | 9060675 |
| Product codes | QKR |
| Device names | QKR - Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QKR |
| Review panels | General Hospital |
| Registered establishments | KAO CHEN ENTERPRISE CO., LTD. |
| Establishment registrations | 3004129296 |
| FEI numbers | 3004129296 |
| 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