FDA device listing
Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
FDA device listing 1919440607 · HuiZhou LVB Maternal and Infant Supplies Co., Ltd.
Key facts
| Proprietary names | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) |
|---|---|
| Owner/operator | HuiZhou LVB Maternal and Infant Supplies Co., Ltd. |
| Owner/operator number | 10089060 |
| Product codes | HGX |
| Device names | HGX - Pump, Breast, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.5160 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO., LTD. |
| Establishment registrations | 3029952735 |
| FEI numbers | 3029952735 |
| 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