FDA device listing
Helmet, Cranial, for Protective Use
FDA device listing 1854484174 · Guangmei VN Production Service Trade Company Limited
Key facts
| Proprietary names | Helmet, Cranial, for Protective Use |
|---|---|
| Owner/operator | Guangmei VN Production Service Trade Company Limited |
| Owner/operator number | 10090820 |
| Product codes | NDA |
| Device names | NDA - Helmet, Cranial, For Protective Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | GUANGMEI VN PRODUCTION SERVICE TRADE COMPANY LIMITED |
| Establishment registrations | 3031231834 |
| FEI numbers | 3031231834 |
| Establishment operations | Contract 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