FDA device listing
BARRIER ENVELOPE,IP BAG
FDA device listing 1679172184 · WUXI LYUSMILE IMP AND EXP CO.,LTD
Key facts
| Proprietary names | BARRIER ENVELOPE,IP BAG |
|---|---|
| Owner/operator | WUXI LYUSMILE IMP AND EXP CO.,LTD |
| Owner/operator number | 10082225 |
| Product codes | LMB |
| Device names | LMB - Device, Digital Image Storage, Radiological |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.2010 |
| Review panels | Radiology |
| Registered establishments | WUXI LYUSMILE IMP AND EXP CO.,LTD |
| Establishment registrations | 3021023132 |
| FEI numbers | 3021023132 |
| Establishment operations | Foreign Private Label Distributor |
| 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