FDA device listing
Manual Breast Pump XB-8610,Manual Breast Pump XB-8611,Manual Breast Pump XB-8612,Manual Breast Pump XB-8639,MOTIF…
FDA device listing 1188573313 · Jiangsu Xinbei Electrical Appliances Co., Ltd
Key facts
| Proprietary names | Manual Breast Pump XB-8610,Manual Breast Pump XB-8611,Manual Breast Pump XB-8612,Manual Breast Pump XB-8639,MOTIF COLLECTION CUP RESUPPLY,MOTIF ROAM 28MM BREAST SHIELD,MOTIF ROAM BOTTLES,MOTIF ROAM COLLECTION CUP & SHIELDS,MOTIF ROAM DIAPHRAGMS,MOTIF ROAM FLANGE RESUPPLY,MOTIF ROAM INSERTS (15/13MM),MOTIF ROAM INSERTS (24/21/19/16MM),MOTIF ROAM LANYARD,MOTIF ROAM NIPPLES,MOTIF ROAM TUBING… |
|---|---|
| Owner/operator | Jiangsu Xinbei Electrical Appliances Co., Ltd |
| Owner/operator number | 10048891 |
| Product codes | HGY |
| Device names | HGY - Pump, Breast, Non-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 884.5150 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Jiangsu Xinbei Electrical Appliances CO., LTD. |
| Establishment registrations | 3010334650 |
| FEI numbers | 3010334650 |
| 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