FDA device listing
Ameda GLO Wearable Breast Pump (Model W8S),ardo melia wearable breast pump (Model melia),Ardo Melia Wearable Breast Pump…
FDA device listing 1979239851 · TPH TECHNOLOGY MALAYSIA SDN. BHD.
Key facts
| Proprietary names | Ameda GLO Wearable Breast Pump (Model W8S),ardo melia wearable breast pump (Model melia),Ardo Melia Wearable Breast Pump (Model W8),breast shell insert,Wearable Breast Pump (Model APEX10),Wearable Breast Pump (Model Comfort+) |
|---|---|
| Owner/operator | TPH TECHNOLOGY MALAYSIA SDN. BHD. |
| Owner/operator number | 10090984 |
| Premarket submissions | K242850 |
| 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 | TPH TECHNOLOGY MALAYSIA SDN. BHD. |
| Establishment registrations | 3031566471 |
| FEI numbers | 3031566471 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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